Health & Medicine

American Institute of Health Science and Technology Provides the Best Training for Aspiring Doctors

The American Institute of Health Science and Technology is a medical school in Virginia that takes a progressive approach while training prospective doctors and medical experts so that they may treat their patients with a high level of efficiency. The medical training center adopts a diverse and efficient method of teaching medical students the ways of modern medicine so that they may attain success as practicing medical professionals. Health science is meant to preserve the health and well being of all people so that they can stay fit and have a better quality of life. At the American Institute of Health Science and Technology, students learn about the best ways in which they can diagnose and cure diseases and serve humanity in the best possible manner.

The Healthcare Administration Program as provided by American Institute of Health Science and Technology has been designed to make sure that all the students studying medical science at the institution are able to achieve success in their ventures and that they are able to accomplish their academic goals. The institution also guides young doctors in a way that they are able to use their skills to pursue a medical career direction that they feel is best for them. American Institute of Health Science and Technology is thoroughly committed to provide high quality education to students from the country and other parts of the world, while making sure that the prices are affordable.

One of the most notable programs offered at the American Institute of Health Science and Technology is its Dental Assistant Program. It is one of the best programs for anyone looking to pursue a career in the sphere of dentistry. The comprehensive program has been designed to help potential dental assistants to cultivate the skills and the knowledge that they need to have to resolve the dental problems that the patients may have. The program can help students to develop a strong understanding and foundation of dental assisting. It encompasses various subject matters central to dental healthcare, such as dental anatomy, dental radiography, infection control, dental materials, oral health education and chairside assisting techniques. The program combines the best of practical training and theory to make sure that the students are able to cultivate the necessary skills that they must have for providing top notch oral healthcare. 

By signing up for one of the medical assistant programs offered at the American Institute of Health Science and Technology, students can enhance their chances of success in the dynamic medical industry.

About American Institute of Health Science & Technology:

The American Institute of Health Science and Technology is one of the leading centers of medical training in the USA, offering a stellar infrastructure to students so that they can learn all about medical science. 

To know more about American Institute of Health Science and Technology, visit

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Elite Benefits Group offers affordable healthcare to all

At Elite Benefits Group, Sierra Gilmore assists individuals with gaining access to the health insurance premiums they deserve. She is a certified marketplace insurance expert. This simply means she has knowledge to navigate the marketplace for you and utilized the Affordable Care Act to ensure you are not overpaying for your health insurance. Many people do not know they qualify for free or super low budget premiums. Sierra knows and will ensure you get the health insurance you deserve. The affordable care act is income based. Therefore your premium is always affordable for you and your financial situation. 

Many people qualify for a subsidency from the government based on their annual income. She helps you access that information. Navigating the marketplace alone can be overwhelming but having an expert makes the process easier and most likely will save you money. 

Not only do she assist individuals but she also assist business such as daycares, home health care agencies and many more set up insurance plans for their employees. Many business say that having Sierra as their personal insurance agent has increased their retention rates. She give employers traditional and non traditional options to ensure they are providing their employees with benefits. 

Elite Benefit Group, a leading and reputable insurance brokerage company based in the US, assists numerous organizations and individuals in locating cost-efficient insurance coverage.

Given the rising cost of healthcare, affordable healthcare has long been a hot topic in the media and public discourse. In addition to assisting low-income families, self-employed individuals, daycare workers, and individuals in navigating the complex world of health insurance, Elite Benefits Group specializes in assisting individuals and businesses find affordable healthcare insurance by comparing plans and prices to find a plan that best suits their requirements and financial situation.

At Elite Benefits Group, a wide range of clients, from small businesses to large corporations and individuals, benefit from their diverse insurance services, which include health, life, and disability coverage, as well as other insurance options. The company is committed to offering personalized service, working closely with each client to identify their distinct needs and objectives, and crafting tailored insurance solutions that precisely match those requirements. The collaborative approach ensures that each client’s unique needs and objectives are fully comprehended, leading to the development of customized insurance solutions.

Angela Knight of House Of Pies, a client said “Being a small business trying to offer extensive benefits to your employees can be overwhelming and expensive. Elite Benefits Group made this task affordable, and understandable and gave our employees great coverage at a low cost to the company. I would and have recommended Elite Benefits Group to everyone!” 

Elite Benefits Group provides consulting services for employee benefits and human resources in addition to insurance brokerage services. Their services involve aiding businesses in creating and implementing employee benefits packages that not only attract and retain high-caliber talent but also ensure compliance with regulatory requirements. Elite Benefits Group understands the challenges of rising healthcare costs and the importance of having access to affordable healthcare. One way Elite Benefits Group helps its clients find affordable healthcare is by comparing plans from different insurance carriers. They can help clients understand the differences between plans, such as deductibles, copayments, and out-of-pocket maximums, and how those differences can affect the overall cost of the plan.

Elite Benefits Group also assists clients to navigate government programs like Medicaid and Medicare, as well as other options for low-cost or free healthcare. 


Elite Benefits Group is a company that specializes in providing insurance brokerage and consulting services to businesses and individuals. The company is based in the United States and has been in operation for over a decade and hope to reach anyone looking for affordable healthcare because it’s affordable to everyone. 

Business Health & Medicine Professional Services Public Affairs U.S

The Sosa Insurance Group Is Looking for Medicare Insurance Brokers To Join Their Brokarage Firm In New Jersey

West Orange, NJ — The Sosa Insurance Group, a trusted Medicare Health Plan Insurance Agency, is looking for new team members to help serve their growing customer base in New Jersey. With a study from the Social Security Administration showing that 13,000 individuals turn 65 every day, this demographic puts Medicare Insurance Health Plans in high demand.

George Sosa, the co-founder of The Sosa Insurance Group, said, “There are not enough insurance brokers in the field to inform and educate and, most importantly, find the right health plan to fit those Medicare-eligible individuals’ needs and affordability.”

The Sosa Insurance Group seeks a self-starter who would like to work as an independent contractor. As a Licensed Insurance Broker of The Sosa Insurance Group, the chosen individual will spend their time informing and educating the Medicare-eligible consumer, assisting the consumer in selecting the appropriate plan for them, and following up with the client to make sure that the application process goes smoothly from start to finish.

This position offers flexible hours and can be full-time or part-time, depending on availability. The ideal candidate is an individual with an entrepreneurial spirit, inherent self-discipline, good time management, a willingness to learn, and an aptitude for sales, and is comfortable working with computers and adapting to changes. Successful agents also have energetic and engaging personalities, excellent communication skills and empathy for others, a genuine passion for helping others, and the ability to overcome sales objections and close leads over the phone.

As an independent contractor, the chosen individual will have the freedom to achieve the level of success they deserve while they build a solid business that will give them an opportunity to receive Lifetime Residual Income, as long as the client is on their book of business. Compensation and benefits include uncapped commission potential, compensation based on a per-client basis, and lifetime residual income from clients assisted in the previous year(s).

The Sosa Insurance Group is unique in its training offerings, providing local support and training remotely, face-to-face, and in the field. Special preference is given to individuals with a health/life license in NJ.

For more information about the position, please visit our website at

About The Sosa Insurance Group  

The Sosa Insurance Group is proud to offer the West Orange, NJ community top-notch Medicare and Financial Service Plans. Founded in 2014 by George Sosa, we specialize in Medicare Supplement, Medigap, Medicare Advantage, Medicare and Medicaid, Stand-Alone Part D Prescription, Dental, Final Expense, Individual, Long-Term Care Plans, and Financial Service Plans.

George Sosa has been in the Sales and Marketing field for 30 years, holding a B.A. from Rutgers University and having completed numerous continuing education courses and seminars in sales, marketing. Fluent in Spanish, he is a devoted father of three children who founded the company to help retirees and provide flexibility and stable income to brokers. With a passion to inform and educate retirees on the importance of the right Medicare Health Plan, we have become a well-respected presence in West Orange.

Health & Medicine Science Technology U.K U.S

FDA Releases Draft Guidance for Decentralised Clinical Trials; Adoption of DCT is Expected to Increase

The US Food and Drug Administration (FDA) has reportedly released a draft guidance detailing its recommendations on performing decentralised clinical trials (DCTs) for drugs, biological products and medical devices.

With the draft, FDA is committed to providing trial sponsors, researchers, and other stakeholders with guidance on how to accelerate DCT adoption to facilitate drug development, reported European Pharmaceutical Review.

FDA’s New Draft Guidance

The newly issued draft guidance is developed on the recommendations the agency detailed in 2020. With the earlier guidance, FDA aimed to help study teams facilitate trial decentralisation in response to the disruptions (e.g. travel restrictions, site closure, quarantines) and public health emergencies caused by the COVID-19 pandemic. 

“The FDA has long considered the benefits of decentralised clinical trials. Advancements in digital health technologies and the COVID-19 pandemic – when in-person visits were limited or unavailable for many trial participants – have accelerated the broader adoption of these activities,” explained FDA Commissioner Dr. Robert Califf.

This new draft offers recommendations related to the FDA’s conditions for investigations of medicinal products when applied to decentralised studies and meets the requirement outlined in section 3606(a)(1), FDA Omnibus Reform Act (FDORA).

FDA released the guidance a few months after the EU regulators demonstrated their recommendations on DCT to help protect the rights and well-being of the trial participants.

In the draft guidance, FDA provides stakeholders with recommendations on DCT design, conducting remote clinical trial visits and clinical trial-related activities, the adoption of digital health technologies (DHT) as enablers of clinical research, the responsibilities of the involved stakeholders, and how investigational medicine should be administered.

Breaking Down the Recommendations

Providing a framework for DCT design, FDA stresses the importance of having a physical location while conducting DCTs to ensure easy access to participant records and investigators’ care.

The trial protocol should clearly define when a tele-health checkup is required and when a patient needs an in-person visit.

FDA urges investigators to confirm participant identity during each remote visit.

According to the agency, the protocols for using DHTs in a virtual trial to gather data for trial endpoints should be compatible with the draft guidance “Digital Health Technologies for Remote Data Acquisition in Clinical Investigation”.

Additionally, in the newly released draft guidance, the FDA has urged sponsors to strive for enhancing participant diversity and inclusiveness in clinical trials. 

FDA stresses the importance of engaging local healthcare providers (HCPs” in trial activities to build trust with at-risk participants, thus improving the inclusion of diverse populations. 

While DCTs and hybrid models can encourage a much higher enrollment rate, FDA suggests investigators recruit only as many participants as they can efficiently manage to provide enough supervision of trial-related activities. 

According to the agency, while taking remote consent from the trial participants, they should be informed about whom to contact in case they face any health issues during the trial period and who can access their personal health information (PHI) acquired during the DCT.

FDA underscores leveraging central IRB in decentralised trials as a key to facilitating the review of the protocol, the informed consent documents, and other pertinent trial data.

In addition, investigational products (IP) should be administered to the participants only under the in-person supervision of the investigator or the supervision of a sub-investigator answerable to the investigator.

It’s recommended for sponsors to take into account the type of an investigational device, its prospective application, and the associated risks to determine its use cases efficiently.

IPs can be directly delivered to the participants’ location and the trial protocol should clearly define the methods of preserving the integrity and stability of the IP.

FDA recommends the use of a centralised distribution system to facilitate the delivery of IP to trial participants.

The sponsor is responsible for thoroughly monitoring the DCT processes while ensuring the trial is being conducted per the general investigational protocols and considerations included in the IND or IDE applications. 

The implemented safety monitoring plan in a trial should be devised considering the decentralised nature of the investigation. It should ensure any adverse events are detected early, correctly captured, and efficiently addressed.

FDA suggests sponsors implement high-end DCT software that can help manage electronic case report forms (eCRFs) and electronic informed consent (eConsent), schedule trial activities, sync data input in DHTs, and more. 

High-end DCT platforms such as ObvioHealth can efficiently address the issues of data inaccuracy and the interoperability essential to produce robust trial outcomes and endpoints.

Wrapping Up

Decentralised and hybrid study models are considered the way forward to decrease the patient burden. Offering participants the support and flexibility they need, DCTs also help improve data quality. 

The result: augmented trial result and accelerated drug development

“As we seek to improve our evidence generation system, decentralised clinical trials may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility,” commented FDA Commissioner.

Computers & Software Health & Medicine Pharmaceuticals & Biotech Science U.K

The Biggest Compliance Issues Faced by MedTech Companies Transitioning to Data-Enabled Solutions

In April, the UK Medicines and Healthcare Products Regulatory Agency (MHPRA) released a guidance document, called Software and Artificial Intelligence as a Medical Device. This document is a compilation of previous guidance, advice, and regulatory requirements for Software as a Medical Device (SaMD) and Artificial Intelligence as a Medical Device (AIaMD).

The document covers:

  • How software as a general medical device or an IVD should be classified
  • What the UK regulatory framework is for SaMDs
  • A change programme roadmap for software and AI as a medical device
  • How to qualify and classify one’s SaMD, including how to create an intended use statement
  • Reporting adverse events once the SaMD is in use, and requirements for field safety corrective actions
  • The guiding principles to inform the development of Good Machine Learning Practice (GMLP) for artificial intelligence

This document has been developed keeping in mind the goal of advancing software and AI medical device regulation. With these technologies becoming a growing part of the MedTech industry, this seems like a reasonable next step.

Data-Enabled Solutions in MedTech

Whilst software and AI as a medical device is a growing market which is now at the forefront due to the rapid rise in the use of AI, it’s not a completely new idea.

Technology has been in use in medicine and medical research for a while now. However, as computing grows more sophisticated, so do the devices.

In fact, across the pond, there is a growing concern about regulatory compliance issues surrounding MedTech. 

Earlier this year, an article in Med City News talked about the top five compliance issues faced by MedTech companies transitioning to data-enabled solutions.

Here they are.

Compliance Issues That MedTech Companies Face

Managing How the Data Is Collected, Used, and Shared

Smart MedTech solutions rely on data gathered from the people who use them. That is why the first issue to consider is related to data gathering and storage.

Companies that use MedTech-enabled data platforms are obligated to take appropriate care of any information collected, including,

  • Patient data
  • Drug development data
  • Customer or provider data
  • AI/ML-developed data sets

Any data collected, used, or shared must be prioritised with the following in mind:

  • Legal mandates
  • GDPR
  • Others
  • Ethical values
  • Patient rights and dignity
  • Patient care and care quality
  • Minimising patient risk and burden
  • Data access

Keeping the Changing Interactions Between Patients, Physicians, and Other Stakeholders in Mind

Medical care is shifting from treatment to preventative treatment, which has led to a change in how patients interact with healthcare providers.

This means that not only is the relationship between them changing, but there’s also an increase in the use of technology for patient monitoring and real-time data entry.

This data collection would require greater collaboration with stakeholders, which is something to consider when planning compliant protocols.

Planning New Regulation Regimes for Donation of EHR, Cybersecurity Technology, and Information Blocking

Electronic Health Records (EHR) are replacing the old paper documentation. These EHRs can be shared between health systems and providers for the sake of interoperability. 

However, those donations need to be adequately tracked.

There needs to be a system in place to ensure there is a legitimate need for the adoption and topics such as updates and replacements have been addressed

Additionally, the provider of this information must not engage in “information blocking”, which has been defined as any activity that impedes the exchange or use of the health information.

Addressing Value-Based Care Considerations and the Federal Anti-Kickback Statute Safe Harbours

Data-enabled MedTech has the potential to make patient care much more empathetic, streamlined, and comprehensive. However, these qualities rely on better design and regulations.

At the same time, MedTech companies also need to ensure that their practices align with the regulatory requirements of the federal Anti-Kickback Statute safe harbours.

Balancing the Lack of Advanced Industry Standards Against a Rapidly Growing Technology

MedTech and communication technologies have exploded in the last couple of decades. And, the rise of AI has been even more dramatic. As such, the existing rules and regulations need to evolve with these new developments.

Managing regulatory compliance, especially for an industry like MedTech, can be quite challenging. That is where companies like RegASK can help. Such a service can help one not only maintain compliance but also keep up with any changes.

As is evident from the rise of tools like ChatGPT, the world is going to see more automation through AI. The important thing is to design compliance regulations that are as effective and as scalable as that technology.

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Canadian Nurse Launches Life Management Logbooks and App to Help People Organize and Protect Important Documents

British Columbia (April 23, 2023) – Organize your life and documents simply, safely and securely with the My Life Manager and My Health Manager logbooks and a mobile app developed by Canadian Registered Nurse, Katrina Mulberry.

The truth is that many people do not have a problem storing important documents but creating an organized system for quick retrieval is often where the rubber meets the road. Searching for unorganized documents can be time-consuming and frustrating, especially in emergencies. But not anymore.

Touted as The Ultimate in Life and Healthcare Organization, Mulberry’s My Life Manager and My Health Manager guides are designed to help users store and organize important documents efficiently and securely for easy access. My Life Manager is a personal record keeper that allows users to record personal and legal documents and other information in one place. The logbook features a beautiful layout of tables and forms to help users effortlessly monitor and track finances, assets, insurance payments, debts, and life goals. My Health Manager is a 28-page healthcare guide that allows users to record and track health and lifestyle details, from medications, test results, family health patterns, and more. An essential tool for cargivers and those with health concerns.

My Life Manager app facilitates seamless and secure storage of documents and information for access on the go. Users can store important documents digitally, keep pictures of cards, and monitor important dates such as passport expiry! The app also serves as a backup for when My Life and Health Manager logbooks are not accessible and worse case when important documents are lost. No data is collected in this Locker App and biometrics are used for security.

My Life Manager and My Health Manager logbooks are an updated version of Mulberry’s original edition of a simple binder with tabs and plastic page holders for original documents and a “learn how to budget” section, which she designed with the advice from her financial planner and business associates. The logbooks received such positive reception especially from fellow parents wanting to teach money management to their teens. This motivated Mulberry to revise and improve the tools to reach a wider audience. The logbooks and app are part of the Manage Me ™ brand that also includes the Manage Me™ Life / Health USB portable data sticks.

According to Mulberry, the idea of creating a Life Management system was considered early in her nursing career after witnessing the inefficiency of sharing medical information. Explaining her motivation for creating the logbooks, she said: “Friends were always impressed at how I managed to juggle my own life and work with my homelife raising four daughters. I told them that the secret was life organization. I created the logbooks and app to share my knowledge with friends and those far and wide who needed who needed more organization in their lives.”

My Life Manager and My Health Manager are designed to be a personal record keeper and are ideal for anyone looking for life organization made simple – from students and entrepreneurs to homemakers and senior citizens. The logbooks are available for purchase on Amazon, Barnes and Noble, Walmart, and other online bookstores. My Life Manager app is available for download for Apple and Android devices. For further information, visit:

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Breaking News: Virtual Nurse Rx Offers A Solution To The Burnout Epidemic Among Healthcare Professionals


Sun City Center, Florida — As the number of healthcare professionals suffering from burnout symptoms continues to rise, Virtual Nurse Rx is offering health workers a solution. With virtual assistants specially trained to help medical professionals and healthcare workers, Virtual Nurse Rx is changing how healthcare professionals approach their daily work lives.

“Our virtual assistants are dedicated to helping healthcare professionals avoid burnout,” said the co-founder of Virtual Nurse Rx, Lexcibel Colon. “We understand the challenges and stress that healthcare professionals face daily, and we’re committed to providing them with the support they need to continue doing their important work.”

“Burnout syndrome is a real problem for many healthcare professionals. According to the World Health Organization (WHO), as many as 52% of healthcare workers reported burnout symptoms in 2022. Burnout can significantly impact a person’s health and quality of life, causing physical symptoms such as exhaustion and anxiety. Virtual Nurse Rx recognizes this issue and has created a solution to help healthcare professionals avoid the signs of work burnout.

What Are The Symptoms Of Burnout?  

Burnout is a common issue for medical professionals and can seriously impact their well-being and work performance. Here are some common symptoms:

  1. Emotional exhaustion: This is a feeling of being emotionally drained, and it can lead to a lack of motivation and energy.
  2. De-personalization: This refers to a feeling of detachment from patients or colleagues, and it can result in a lack of empathy and compassion.
  3. Reduced sense of accomplishment: A mental health professional with burnout may feel that his/her work is no longer fulfilling or rewarding, leading to a sense of hopelessness or despair.
  4. Physical symptoms: Burnout can cause headaches, stomach problems, and sleep disturbances.
  5. Cognitive difficulties: Affected persons may experience difficulty concentrating, making decisions, or remembering things.

If you are experiencing any of these symptoms, it may be a sign that you are overworked. Addressing these symptoms and seeking support to prevent occupational stress from impacting your work and personal life is important.

The Solution To Burnout  

Virtual Nurse Rx’s virtual assistants are trained registered nurses who assist healthcare providers with their daily tasks, freeing time to focus on patient care and their physical and emotional health. By delegating routine tasks to a virtual assistant, a healthcare professional can reduce his/her physical workload, increase productivity, reduce their risk of burnout, and improve their work-life balance.

Virtual Nurse Rx’s virtual assistants are also trained to work seamlessly with healthcare practitioners and mental health professionals, ensuring they can focus on public health and treat patients without worrying about administrative tasks that can cause job burnout. With Virtual Nurse Rx’s solution, healthcare professionals can go from little or no control over their workload to complete control, balancing their work and personal lives, reducing the risk of burnout, and improving mental health and their overall quality of life.

About Virtual Nurse Rx  

Virtual Nurse Rx is a leading provider of virtual assistant services for healthcare professionals. Their medical virtual assistants are trained to work with healthcare professionals, providing them with the support they need to focus on patient care. With a focus on reducing burnout among healthcare professionals, Virtual Nurse Rx is changing how health professionals approach their job and daily work lives.

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Say Goodbye to Overpriced Dental Supplies and Equipment with Dental Whale’s Exclusive Ordering System

The Dental Whale Purchasing Management System is designed to help dental practices save money on supplies, labs, and equipment. By using this system as your go-to ordering portal, your dental practice can save up to 40% every time you place an order.

The system streamlines the ordering process by providing a single point of contact, making it easy to restock supplies and order new equipment. The platform also offers top brands at discounted prices, and the purchasing power of Dental Whale ensures that practices get the best possible deal.

Sunrise, Florida — Dental Whale, a leading online supplier of dental equipment and supplies, has launched an exclusive ordering system to help dentists and dental practices save up to 40% on their purchases. The new system is designed to simplify the ordering process, reduce wasteful spending, and offer top-quality products from the biggest names in the industry.

In an evolving ecosystem, new technologies and products are constantly emerging in the dental industry. However, the cost of dental supplies and equipment can be prohibitive for many dental practices, particularly those just starting out. That’s where Dental Whale comes in.

The Dental Whale Purchasing Management System makes it easy for dental practices to find and purchase the products they need at an affordable price. With this system, practices can streamline their supply and equipment procurement, reduce wasteful spending, and make more informed purchasing decisions.

“We understand the challenges dental practices face when it comes to managing their supplies and equipment,” said a spokesperson for Dental Whale. “That’s why we created our exclusive ordering system – to help dental professionals get the products they need at a fair price. We’re excited to offer this new system to dentists and dental practices across the country.”

The Dental Whale Purchasing Management System offers a wide range of products, including dental supplies, equipment, and materials. The system features top brands, ensuring practices have access to the best products in the industry. In addition, the system is easy to use and navigate, allowing dental professionals to find the products they need quickly and efficiently. Learn more here:

To get started with The Dental Whale Purchasing Management System, dental practices need only to create an account via the Dental Whale website. From there, they can browse the extensive selection of products, add items to their cart, and checkout using the secure online payment system. The system also allows practices to track their orders, view their purchase history, and save their favorite products for future orders.

“We believe that every dental practice deserves access to high-quality products at an affordable price,” said the spokesperson for Dental Whale. “Our exclusive ordering system is designed to help practices save money and simplify their ordering process. We’re proud to be leading the way in affordable dental supplies and equipment, and we look forward to helping more practices cut costs and increase their bottom line.”

In conclusion, The Dental Whale Purchasing Management System is a game-changer for dental practices looking to save money on their supplies and equipment. With its user-friendly interface, extensive product selection, and exclusive discounts, the system makes it easy for practices to get the products they need at a fair price. Dental Whale is proud to offer this new system to dental practices across the country, and looks forward to helping more practices cut costs and increase their profits.

About Dental Whale:

Dental Whale helps dental practices maximize their profits. We provide only the best, top-brand supplies and equipment for dentists, ensuring savings of up to 40%. With an experienced team of experts on staff, you can trust us with all your dental needs so that you never have to worry about your bottom line again. Find out more by visiting our social media pages: Facebook, LinkedIn, and Instagram.

Computers & Software Health & Medicine Technology U.K U.S

ObvioHeath to Conduct Decentralised Clinical Trial on Mi-Helper Device: Treatment of Migraines Expected to be Facilitated

On March 16th, Mi-Helper, Inc. and ObvioHealth reportedly declared a collaboration to carry on a decentralised clinical trial (DCT) in order to analyse the effectiveness of a non-invasive neuromodulation (nVNS) device. 

This nVNS device, called Mi-Helper, is expected to facilitate the treatment of migraines.

According to NeuroNews, the device will be used for a randomised, controlled, and fully remote clinical trial where patients with migraine issues will be able to record essential data from the comfort of their homes.

The partnership will ensure a cost-effective and accessible remedy for this debilitating neurological condition that affects around one billion people across the globe.

Migraines: a Quick Overview

Migraines are described as miild to severe headaches that cause intense, throbbing pain. The burden and prevalence of self-reported migraine and severe headaches in the adult population in the USA are high, affecting more than 39 million Americans, according to Migraine Research Foundation.

In addition, roughly one in every seven adults in the U.S. suffer from migraines. The economic costs of migraine-based diseases were evaluated to be USD 36B in 2016, taking into account the factors such as loss of productivity (i.e., inability to work) and medical costs, according to the NIH.

On top of that, in a recent study published in AANP, more than 40% of migraine patients reported dissatisfaction with existing treatments because of precautions, tolerability issues, lack of efficacy, or contraindications between medications.

The Collaboration will Facilitate Migraine Treatment

With the partnership, both companies expect to devise a more targeted, effective, and non-drug pain management system for people suffering from migraines.

A small, non-invasive therapy device, the Mi-Helper delivers an on-demand stream of conditioned air intermixed with nebulised mist to the mucosa membranes in the nose to help recover from migraine pain and related symptoms, for instance, photosensitivity and nausea.

“We are working with the top headache neurologists in the world to inform our clinical studies,” said Steve Schaefer, CEO of Mi-Helper. “And, we are committed to delivering a paradigm shift for migraine treatment—fast, accessible, and affordable relief for this highly complex and debilitating neurological disease.” 

With the partnership, both companies are committed to increasing diversity in the trial by enrolling the underrepresented social, racial, and ethnic minority groups from all over the continental United States. 

“Mi-Helper and ObvioHealth are dedicated to inclusivity,” said Ivan Jarry, CEO of ObvioHealth. “By designing a decentralised clinical trial without the need for physical site visits, we can recruit patients anywhere in the continental United States, including underserved communities. This will provide Mi-Helper with essential data on a real-world population in a real-world setting and should help to ensure that the device, when launched, can serve a broad population.”

Featuring a DCT-based adaptive design, the study is expected to start enrolling participants this summer.

The ObvioGo app, which will be used for conducting remote study, is expected to improve patient centricity in the trial by allowing patients to participate, consent and document any critical conditions remotely. 

ObvioHealth has confirmed that its experienced COACH team will ensure remote and real-time monitoring of patient safety and compliance.

Financial Market Health & Medicine Public Affairs Technology U.S

Community Health Systems Completes Divestiture of its Last Hospital in West Virginia for $92M

Tennessee-based healthcare giant, Community Health Systems (CHS), has reportedly divested its 25-bed Plateau Medical Center (PMC) in Oak Hill, West Virginia, to the affiliates of Vandalia Health. Vandalia Health is the parent company of Charleston Area Medical Center (CAMC).

The transaction, according to businesswire, was put into effect on April 1, 2023.

Details of the Divestiture

Closed on April 3rd, 2023, the sale of Plateau Medical Center is worth roughly $92M. Besides the medical center, the sell-off includes PMC’s outpatient services, physician clinic operations, and respective assets.

The agreement for the Plateau Medical Center acquisition was inked earlier this year.

“As a critical access hospital, Plateau Medical Center plays an important role in the Oak Hill community and beyond,” said David Ramsey, president and CEO of Vandalia Health and CAMC. “We are excited they are joining CAMC and Vandalia.”

Now that the transaction is finalised, CAMC is about to hold sway over the hospital operations and work with the medical staffers as part of its effort to deliver proactive services to the region. 

“The staff is terrific,” Ramsey stated. “They do a great job of taking care of the community and the patients that come to them.”

Plateau Medical Center

Previously a for-profit hospital, Plateau Medical Center is a certified 25-bed hospital with more than 315 staff on the Oak Hill campus and in nearby clinics. The specialised services it offers are paediatrics, family practice, emergency medicine, cardiology, internal medicine, and general surgery.

CAMC is a not-for-profit organisation; funds raised from the hospital will be used for the betterment of the state and the people of the Oak Hill area.

CHS Continues with Hospital Sell-off

The divestiture of Plateau Medical Center is one of the potential sell-offs CHS detailed on its final quarter and fiscal year-end 2022 earnings call.

With this transaction, CHS has ceased its services in West Virginia. 

The agreement to sell the PCM took shape over two years after CHS had completed the massive divestiture of a hospital program that dropped its hospital count to 79 from its peak at 206.

The CHS now runs 78 acute-care hospitals and around 1,000+ other healthcare sites, including emergency care centres, imaging centres, physician practices, cancer centres, freestanding emergency departments, occupational medicine clinics, and ambulatory surgery centres.

On January 1, 2023, CHS sold Greenbrier Valley Medical Center — a 122-bed healthcare facility based in Ronceverte, W.Va. — to Vandalia Health for a cash consideration of around $85M.

CHS has been selling hospitals recently as part of its effort to improve its financial position while also reducing its heavy debt load.

The hospital giant has encountered significant losses over the past several years, including a $2B loss in the final quarter of 2017. 

Overcoming Divestiture Challenges

Whether it’s a spin-off or an equity carve-out, divesting a business asset is a complex transaction that comes with strict time constraints. 

For businesses undergoing a divestiture, investing in a high-end carve-out consulting service like Fission Consulting is a sensible business decision.

Industry-leading IT transformation services can mitigate investment risk and help businesses make more informed decisions while significantly accelerating the overall separation timeline.

Wrapping Up

Community Health Systems, one of the largest publicly traded hospital companies in the U.S., continues hospital sell-off with the divestment of Plateau Medical Center. With this divestiture, CHS has no remaining hospital in West Virginia.