Tag: medical

Nonprofit Chosen BCS aims to ensure all have access to needed medical equipment

BRYAN, Texas (KBTX) – In a recently leased warehouse on Texas Avenue in Bryan, Chosen BCS, a faith-based, community-oriented organization is working to be a lifeline to those in need of durable medical equipment.

The nonprofit is set to open in the next month and has already started to collect new and gently used medical equipment like wheelchairs, canes, walkers, hospital beds, and more, all to distribute to people in need.

Chosen is an international ministry based out of Erie, PA with local distribution and collection sites across the country.

Longtime Brazos County resident Sara Hadley is the director of Chosen BCS Pavilion Texas. Once operational, she says the ministry aims to bridge the gap for people needing medical supplies.

“Medical equipment is essential for the care and well-being of many individuals. Unfortunately, many people cannot afford it or have limited access to it,” says Hadley. “Chosen seeks to offer a beacon of hope and lifeline to those who need medical devices to enable them to live their best life.”

“There are no boxes to check, no income or insurance requirements, or timelines to fulfill. Locally, we distribute everything from gauze to hospital beds to anyone who expresses a need for our staff,” said Hadley.

The Brazos County District 2 Volunteer Fire Department recently made the first donation to Chosen BCS.

“Excited to see Chosen B/CS take what we were doing with our medical supply loan closet to the next level to serve the entire county, and then some,” the district said in a social media post.

Hadley says the hearts this team has for God and His people is the most inspiring and the driving force behind bringing this ministry to the Brazos Valley.

For more information on Chosen BCS and how you can get involved call 979-204-1104

Equipment includes:

  • Canes
  • Crutches
  • Walkers
  • Bedside Commodes
  • Toilet Rails
  • Bed Canes & Bed Rails
  • Wheelchairs
  • Transport Chairs
  • Pulmonary Walkers
  • Knee Scooters
  • Reclining Wheelchairs
  • Shower Chairs & Transfer Benches
  • Toilet Risers
  • Hospital Beds & Mattresses
  • Bedside Tables & Bed Trays
  • Nebulizer Machines and Accessories
  • Incontinence Supplies
  • Blood Pressure Monitors (Home Use, Non-Mercury)
  • Hoyer Lifts, Hoyer Slings, & Sara Lifts
  • Feeding Bags and Tubing
  • Medical Supplies (Gloves, Wipes, Etc.)
  • Diabetic Supplies
  • Wound Care Supplies (Bandages, Gauze, Etc.)
  • Shoes
  • Step Stools
  • Transfer Boards
  • Shower Grab Bars
  • Tub Rails
  • Sock Aids & Shoe Horns
  • Dressing Sticks
  • Reacher/Grabbers
  • Leg Lifters
  • Oxygen Concentrator
  • O2 Carriers
  • Humidifier Machines
  • Portable Ramps
  • Lift Chairs
  • Cushions (Wedge, Egg Crate, Donut, Wheelchair)
  • Colostomy Supplies
  • Other (Please Contact Prior to Dropping Off)

Copyright 2023 KBTX. All rights reserved.

Virginia Republicans Vote Against Apology for Misusing Black Bodies for Medical Research, Citing ‘No-End’ to Number of Amends Needed

Virginia lawmakers have decided not to move forward with legislation that would officially apologize for the state-sanctioned misuse of Black body parts over the past two centuries.

As far back as the 1800s, Old Dominion allowed medical professionals to conduct research on African-American bodies, living and dead, without their or their family’s permission. Some politicians were hoping in vain the state legislature would own up to exploitation.

However, on Friday, Feb. 17, the Rules subcommittee of Virginia’s House of Delegates voted 4-1 to lay SJ 274 on the table. This act, according to the Virginia Mercury, indefinitely killed the resolution.

Virginia House Speaker
RICHMOND, VA – FEBRUARY 3: Delegate Todd Gilbert, left, a Virginia republican representing the Shenandoah district, talks to fellow delegates on the House floor of the Virginia State Capitol in Richmond, Virginia, Monday, February 3, 2014. (Melina Mara/The Washington Post via Getty Images)

Four Republicans among the subcommittee’s five members, House Majority Leader Terry Kilgore, Speaker Todd Gilbert, Del. Barry Knight, and Del. Kathy Byron, shut it down.

Titled “Unethical use of Black bodies by medical institutions; acknowledging with profound regret,” the bill was introduced by Democratic Sen. Jennifer B. Boysko of Fairfax.

During her presentation of the bill, she said it was important to acknowledge the past wrongs perpetrated by the government in order to heal wounds created by those wrongdoings.

Gilbert, one of the Republicans who voted against the resolution, said during the meeting, “I feel like there are thousands upon thousands of equally painful and hurtful and regrettable stories that could be told about how we treated one another, how Black Americans were treated for a very long time in this country. And I just worry that there’s no end to these resolutions, and maybe that’s the intent, I don’t know.”

One example of this was when the Medical College of Virginia hired grave robbers to steal Black bodies for medical experimentation in the 1800s when they did not have cadavers available for research.

“But certainly,” he continued. “If it helps for me to acknowledge that fact, that there are these many, many hurtful, painful memories and events and actions that hurt so many people, you know, I’m doing that publicly right now.”

“I just don’t know in the way of legislation how we contribute to that healing by acknowledging one or two a year at a time. That’s my main concern,” he concluded.

After the bill was not affirmed, Boysko said, “I think it’s important that we address problems so we can move forward collaboratively. We know there are Black people who live in Virginia and around the country who are suspicious of health care because of what has happened in the past.”

Adding, “Our bill would have at least admitted that and given people a small peace of mind.” 

Phillip Thompson, the former president of the Loudoun NAACP, believed the resolution would pass because it was supported by many in the senate already, unanimously being passed in that branch of government. However, the House of Delegates proved to be a barrier to the measure.

He said, “I thought it had a chance because it’s a very innocuous bill. We weren’t asking for reparations, nothing like that; we just wanted a real apology.”

Thompson also added that he believes it was so difficult to persuade African-Americans to get the COVID-19 vaccine because of the mistrust born out of the nation’s history of medical mistreatment, including The Tuskegee Experiment.

From 1932 to 1972, about 400 African-American men with syphilis participated in The Tuskegee Study of Untreated Syphilis in the Negro Male by the United States Public Health Service

According to the Centers for Disease Control and Prevention, the study initially involved 600 Black men (399 with syphilis, and 201 who did not have the disease). Participants were told they were being treated for “bad blood” but never had informed consent collected.

Despite being in the study, which looked at the sexually transmitted disease, anemia, and fatigue, the men were never offered penicillin to treat their syphilis. Instead, for research purposes, they were allowed to suffer.

“When the COVID vaccines first came out in my community, a lot of African-Americans didn’t want to take those vaccines because they thought that it was like the Tuskegee experiment,” Thompson explained. “Back in the ’30s and 40s, young kids were told don’t stray too far because the body snatchers will get you.”

Boysko explained in her bill presentation that this kind of warning was plausible.

She reminded the group that in April 1994, nine of the 53 bodies discovered in Richmond’s East Marshall Street Well dug up on Virginia Commonwealth University’s MCV Campus were discovered to be mostly from Black children. The human bones found at the well are believed to have been discarded in the 1800s by medical staff.

“Many of us still don’t trust the system, and when you look at history, that distrust is justified,” Thompson said.

In September, Virginia Commonwealth University formally apologized for its discarding of Black bodies after dissections. It also issued an apology to the family of Bruce Tucker, a Black Virginia laborer whose heart was removed after his condition was deemed too severe in 1968.

Medical Devices Market Size ($656 Bn by 2032 at 3.0{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} CAGR)






Pune, March 01, 2023 (GLOBE NEWSWIRE) — According to Market.us, the global medical devices market accounted for USD 492 billion in 2022 and is projected to reach USD 656 billion by 2032, exhibiting a CAGR of 3.0{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} in the forecast period (2023-2032).

Medical devices are used to diagnose and treat diseases or injuries. These devices can be used to treat illnesses or improve patients’ quality of life. FDA (Food and Drug Administration) classifies medical devices into three classes: Class I, Class II, and Class III. Because they have the most regulatory controls, Class I and II require special labeling. These are the ones that sustain or support human life. These include an implant endosseous and an external defibrillator. Medical device establishments are those that manufacture medical devices. These devices include in-vitro diagnosis and diagnostic imaging devices.

Medical Devices Market Size (6 Bn by 2032 at 3.0{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} CAGR)

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Medical Devices Market Key Takeaway:

  • By product, the In-Vitro Diagnostics segment (IVD) is expected to have the highest CAGR during the forecast period due to the increasing use of real-time diagnostic testing for diagnosing infectious and chronic diseases.
  • By end-user, the hospitals & clinics segment dominated the market in 2022 because of the rising healthcare spending, better healthcare infrastructure, and an attractive reimbursement policy.
  • In 2022, North America dominated the market with the highest revenue share of 43{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} due to the high treatment rates, supportive government initiatives for early diagnosis of diseases, and the increasing adoption of technologically advanced devices.
  • Asia-Pacific is expected to grow at the highest CAGR between 2023-2032 due to the increasing patient population suffering from chronic diseases and improving healthcare infrastructure.

Complex surgeries and growing numbers are driving this market. In addition, the market for medical devices is expected to grow due to technological advancements in medical technology, brain monitoring devices, and government initiatives.

Factors affecting the growth of the medical devices industry?

Several factors can affect the growth of the medical devices industry. Some of these factors include:

  • Technological Advancements: Advanced technologies like artificial intelligence (AI) and wearable medical equipment are becoming increasingly prevalent in the medical devices market nowadays. This is propelling the market growth positively.
  • Rising chronic diseases: The increasing cases of chronic diseases like cancer, diabetes, etc., will raise the patient population. A sedentary lifestyle is a major reason behind this. This is boosting the market’s expansion.
  • Increasing healthcare expenditure: The increasing per capita healthcare expenditure in developing and developed countries means more opportunities for medical devices, which is positively affecting market growth.
  • Growing awareness about diseases: The growing awareness about infectious diseases and chronic conditions means that individuals are taking necessary treatments readily. This is abetting the market growth positively.

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Top Trends in the Global Medical Devices Market

Remote diagnosis, treatment, and monitoring of patients are possible now because of technologies like remote patient monitoring devices, artificial Intelligence (AI), wearable devices, and electronic health records. Patients can be monitored at their homes and hospitals via contactless technology. This is crucial in controlling COVID-19. Both patients and doctors can have an EHR for their patients. This means they don’t need to deal with traditional paperwork that must be sent through multiple people involved in the treatment. Patients and doctors can view the data on their own devices as well as those of other doctors.

Medical device manufacturers are seeking ways to reuse production lines to produce high-demand supplies to fight against the coronavirus. These products include hand soaps, ventilators, personal protective equipment (PPE), face masks, and other medical supplies. AirCo, a liquor producer, has shifted its focus to hand sanitizers. INKSmith Canada also produces face shields. It was a startup that made technology tools and designs more accessible for children.

Due to rising rates of chronic medical conditions and the treatment of those suffering from them, the healthcare system across different countries is facing immense pressure. This has led to a significant rise in the cost of treating these conditions. Hospital inpatient costs are significantly higher than the hospital charges for those treated at home. Additionally, longer hospital stays can result in a higher economic burden. A recent randomized study comparing hospital patients with those in home care showed that home care management costs decreased by 19{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}. There has been an increase in the preference for home healthcare services due to increasing economic burdens and a growing elderly population. Home healthcare services are becoming more popular in developed countries due to the increasing efforts of key players and healthcare agencies to develop and launch simple-to-use medical devices, such as portable and wearable devices for chronic illnesses. Shimmer Research, a world leader in wearable technology applications, introduced Verisense Pulse+ in March 2021. This sensor is designed for Verisense platforms and provides photoplethysmographs and galvanic skin reactions. This device measures the heart rate and oxygen saturation of clinical trial patients and their activity levels and sleep levels.

Market Growth

Living a lifestyle that leads to physical inactivity can increase the risk of developing heart disease. This will likely increase the demand for medical devices as more heart surgeries are performed to clear blocked arteries. This will help to boost the market growth. This market is expanding because companies focus on creating advanced products and using different business strategies, such as acquisitions or partnerships, to maintain their market position.

Regional Analysis

Regional analysis shows that North America is expected to continue to be the largest market in medical devices. This market dominance is due to the rising prevalence of chronic disease, high healthcare spending, and key players’ presence. Canada’s growing elderly population will likely boost market growth during the forecast period. According to United Nations Population Fund statistics for 2022, Canada has a large population aged between 15 and 64. This group makes up approximately 65{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of Canada’s total population. According to the same source, 19{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of Canadians are expected to reach 65 by 2022. Geriatrics are more susceptible to developing chronic conditions such as respiratory disease, cardiopulmonary disease, and orthopedic disorders. This trend over the forecast period is anticipated drive market growth. A rising number of chronic conditions such as stroke, heart disease, and cardiovascular disease has increased cardiopulmonary bypass procedures; therefore, medical devices have seen a significant increase in demand. According to American Heart Association, the United States is predicted to have a 6.8{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} heart disease prevalence by 2021, 1.8{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} higher than the overall population. This will help to increase demand for medical devices that improves diagnosis and treatment. This will likely boost the market’s growth over the forecast period.

Competitive Landscape

The global medical devices market is fragmented because of the presence of many market players on both a regional and global level. With its extensive product range and international reputation, Medtronic holds the largest market share. Most industry players invest heavily in Research and Development (R&D), which is used to develop new products and improve existing product lines. They also invest a lot in growing their global distributor networks, allowing businesses to diversify product offerings.

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Medical Devices Market: Scope of the Report

Report Attribute Details
Market Value (2022) USD 492 Billion
Market Size (2032) USD 656 Billion
CAGR (from 2023 to 2032) 3.0{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}
North America Revenue Share 43{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}
Historic Period 2016 to 2022
Base Year 2022
Forecast Year 2023 to 2032

Market Drivers

Sedentary lifestyles and other factors increase chronic diseases like diabetes, cancer, and other infections. Through various awareness programs, healthcare agencies worldwide are trying to improve the speed of diagnosis and treatment. Due to the increasing prevalence of these conditions, the number of people who need diagnostic tests and procedures is on the rise. For example, the International Diabetes Federation stated that 537 million people were diagnosed with diabetes in 2021. IDF states this number will rise to 643 million in 2030 and 783 million by 2045.

According to the American Cancer Society, the number of new cancer cases in 2021 was 1.9 million. In addition, there is a rising demand for orthotic or ophthalmic procedures due to increasing numbers of joint fractures and poor vision in the elderly. Osteoarthritis Alliance 2021 data shows that the incidence of knee osteoarthritis is highest in those between 45 and 65 years old. About 45{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of osteoarthritis patients are 65 years old or older. Along with these factors, higher per capita healthcare spending in developing and emerging countries and better reimbursement policies drive an increasing number of patients seeking treatment and diagnosis. This is driving demand for medical devices.

Due to rising rates of chronic medical conditions and the treatment of those suffering from them, the healthcare system across different countries is facing immense pressure. This has led to a significant rise in the cost of treating these conditions. Hospital inpatient costs are significantly higher than the hospital charges for those treated at home. Additionally, longer hospital stays can result in a higher economic burden Shimmer Research, a world leader in wearable technology applications, introduced Verisense Pulse+ in March 2021. This sensor is designed for Verisense platforms and provides photoplethysmographs and galvanic skin reactions. It also has an inertial measurement unit. This device measures the heart rate and oxygen saturation of clinical trial patients. It can also measure their activity levels and sleep levels.

Market Restraints

Most likely, new products and services will be more expensive due to regulatory changes. Data protection is affected by these regulatory changes. These regulatory changes can also affect equipment approval procedures. The US Food and Drug Administration (FDA) has requested additional clinical information. This information is needed to support safety claims and efficacy claims regarding medical devices such as endoscopies. Due to the potential loss of revenue due to delayed product releases and the higher costs associated with the stringent approval process, investments in product development have been under pressure. This can have a negative effect on the growth of medical device and equipment markets.

Market Opportunities

The largest medical device market segmented by type is In-vitro Diagnostics. Hospitals and clinics will benefit the most from the segmented market for medical devices by the end user. With US$ 55,700 million, the USA is anticipated to be the world’s largest medical device market. According to the Business Research Company, medical device companies should concentrate on disposable medical products, contactless medical devices, portable medical devices, and wearable medical gadgets.

A recent randomized study comparing hospital patients with those in home care showed that home care management costs decreased by 19{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}. There has been an increase in the preference for home healthcare services due to increasing economic burdens and a growing elderly population. In addition, home healthcare services are becoming more popular in developed countries due to the increasing efforts of key players and healthcare agencies to develop and launch simple-to-use medical devices, such as portable and wearable devices for chronic illnesses. These factors are creating ample amount of opportunities for the market.

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Report Segmentation of the Medical Devices Market

Product Insight

In-Vitro Diagnostics (IVD) is expected to experience a higher CAGR. This is due to the increasing usage of real-time diagnostic tests to accurately diagnose chronic or infectious diseases such as diabetes, cancer, HIV/AIDS, etc. In addition, the increased demand for medical devices, such as gloves and masks, surgical lights, and fetal monitors, led to the other segments holding a dominant position in 2022. The wound management segment is expected to grow significantly due to the increased investment made by medical device companies into new wound devices and bioactive therapies. Minimally Invasive Surgery is predicted to grow because of technological advancements in surgical robots and increased use by healthcare providers. Due to the increasing number of patients suffering from different cardiac and orthopedic conditions, orthopedic and cardiovascular devices will likely continue growing rapidly. Market growth for medical devices is anticipated to be driven by the increasing incidence of diabetes and retinal disorders in the population.

End-User Insight

This segment’s notable growth can be attributed primarily to rising healthcare spending, improved healthcare infrastructure, and a favorable reimbursement policy. According to the WHO report on healthcare infrastructure, most developing countries have less than 1 million hospital beds. These countries invest heavily in healthcare infrastructure development. As a result, healthcare infrastructure spending is expected to increase over the forecast period.

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Market Segmentation

By Product Type

  • Monitoring Devices
  • Cardiac Monitoring Devices
  • Neuromonitoring Devices
  • Respiratory Monitoring Device
  • Multi-Parameter Monitoring Devices
  • Hemodynamic Monitoring Devices
  • Fetal and Neonatal Monitoring Devices
  • Temperature Monitoring Devices
  • Weight Monitoring Devices
  • In-Vitro Diagnostic Devices
  • Surgical ENT Devices.
  • Endoscopes
  • Imaging Devices
  • Diagnostic Molecular Devices
  • Drug Delivery Devices
  • Surgical Devices
  • Bio Implants and Stimulation Devices
  • Treatment Equipment
  • Infusion Pumps
  • Medical lasers and LASIK surgical machines
  • Other Product Types

By End-User

  • Hospitals & Clinics
  • Diagnostic Centers
  • Research laboratory
  • Pharmaceutical companies (Shopping Plazas, Military, Corporate Sectors, Hostels)

By Geography

  • Western Europe
    • Germany
    • France
    • The UK
    • Spain
    • Italy
    • Portugal
    • Ireland
    • Austria
    • Switzerland
    • Benelux
    • Nordic
    • Rest of Western Europe
  • Eastern Europe
    • Russia
    • Poland
    • The Czech Republic
    • Greece
    • Rest of Eastern Europe
  • APAC
    • China
    • Japan
    • South Korea
    • India
    • Australia & New Zealand
    • Indonesia
    • Malaysia
    • Philippines
    • Singapore
    • Thailand
    • Vietnam
    • Rest of APAC
  • Latin America
    • Brazil
    • Colombia
    • Chile
    • Argentina
    • Costa Rica
    • Rest of Latin America
  • Middle East & Africa
    • Algeria
    • Egypt
    • Israel
    • Kuwait
    • Nigeria
    • Saudi Arabia
    • South Africa
    • Turkey
    • United Arab Emirates
    • Rest of MEA

Key Market Players

Recent Development of the Medical Devices Market

  • FDA granted Abbott’s recall of its imaging catheter a Class 1 label in May 2022 because of vascular injury risks.
  • In January 2022, The US gave FDA approval to Mediatric’s Intellis rechargeable neurostimulator and Vanta recharge-free neurostimulator used for treating chronic pain caused by diabetic peripheral neuropathy.
  • Siemens Healthineers AG launched NAEOTOM Alpha in November 2021, which is the world’s first CT scanner that uses photon-counting technology cleared for clinical use in Europe and the US.
  • In August 2021, Johnson & Johnson introduced VELYS digital surgery. The robot-assisted option for total knee arthroplasty in the United States is now available.

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Remove roadblocks to medical care by nurse practitioners in Indiana

As a physician who provides health care to Hoosiers every day, it’s clear that our state is facing a mounting crisis of care. There simply aren’t enough physicians to meet the skyrocketing patient demand, and many of us are retiring. For years, I’ve worked with advanced practice registered nurses (APRNs) to provide patients with safe, high-quality care. It’s time for the state legislature to remove the legislative roadblocks that prevent patients from choosing APRNs as their health care providers.

Across our state, the physician shortage is having detrimental effects on Hoosiers’ health. Health care costs are up and health outcomes are down. We hear every day that patients are having difficulty scheduling appointments for routine care. The lack of prenatal care is driving up infant mortality rates across our state. Kids devastated by the pandemic can’t get the mental health care they need. The status quo isn’t cutting it anymore and policymakers need to make a change.

Is Your Phone a Medical Device?

Scholar argues that Congress and FDA should treat risky clinical artificial intelligence tools as medical devices.

When the U.S. Congress defined the term “medical device” in the Food, Drug, and Cosmetic Act, it mostly had in mind physical hardware products, such as knee replacements, pacemakers, and surgical instruments.

But today, patients and providers often rely on software tools to improve health. Examples include the Apple Watch’s electrocardiogram app and a smart camera that tells ophthalmologists whether a diabetes patient is at risk of blindness.

In a recent article, professor Sara Gerke of Penn State Dickinson Law proposes that Congress broaden the definition of a “medical device” to encompass risky products that rely on artificial intelligence (AI), and that the U.S. Food and Drug Administration (FDA) exercise regulatory oversight over the makers of some of these products.

Admittedly, FDA has adopted a regulation that treats as medical devices any software used for “medical purposes”—disease prevention, treatment, and diagnosis.

But not all software services related to health care serve medical purposes. FDA clarified in 2019 that software tools that only help users maintain “a general state of health or a healthy activity” are not medical devices. A smartphone app that monitors your exercise activity, for example, is currently not considered a medical device. Neither is software intended to reduce an individual’s risk of chronic diseases or conditions, such as an AI service that helps Type 2 diabetes patients eat a balanced diet for their condition.

In her proposal, Gerke calls for Congress to define such “clinical decision” software as medical devices. Doing so would include many risky AI-based health care products that FDA currently does not regulate, Gerke contends.

Gerke offers AI-based mortality prediction models as a telling example. These algorithms analyze a cancer patient’s medical records to predict likelihood of death within the next six months. Gerke argues that, because such algorithms do not directly relate to the prevention, treatment, and diagnosis of a condition, the current statutory definition of a medical device would likely not cover them.

Hospitals increasingly rely on tools such as cancer mortality prediction models in clinical decision-making, which Gerke claims could jeopardize patient safety. Gerke explains that “a model could lead to the cessation of a patient’s treatment if it incorrectly predicts the patient’s early death.”

Her proposed fix is simple: Congress should amend its definition of a medical device to include clinical decision-making tools that are intended for the “prediction or prognosis of disease or other conditions or mortality.”

Gerke also notes that many AI-based tools, including those used in health care, rely on “black box” machine learning models that hide the logic of how they reach their determinations. This opaqueness makes it difficult for providers and patients to review the tool’s recommendations independently.

Gerke first proposes a “gold standard” solution to the challenges that black-box medical algorithms pose: Congress can require the makers of clinical AI to use a “white-box” model—a transparent system that reveals how the clinical algorithms reach their decisions—whenever a white-box system would perform better than a black-box one.

But if companies can demonstrate that a black-box AI system for a particular product would perform better than a white-box one, then FDA should shift its focus to verifying the tool’s safety and effectiveness, argues Gerke. She suggests that FDA can better accomplish this verification if it regulates these black-box systems as medical devices.

Only then can FDA ensure that black-box algorithms in health care are safe and effective through clinical trials, according to Gerke. For this reason, she proposes that FDA adjust its regulation of these black-box products to match the standards it imposes on more traditional medical devices.

But beyond clinical trials, FDA can do more to bring clinical AI tools into compliance with the agency’s medical device rules and standards, Gerke argues.

FDA mostly takes enforcement action against the makers of AI-based medical devices through a discretionary approach that considers the level of risk that a particular device poses, Gerke explains. And in determining what counts as a “risky” AI-based tool, FDA emphasizes whether the tool allows for the user—whether caregiver or patient—to review independently the software’s decisions. If a tool does allow for independent user review of clinical decisions, then FDA usually will not take regulatory action against the tool’s manufacturer, Gerke describes.

Gerke proposes, instead, that FDA focus its regulatory oversight on two types of AI-based medical devices: those that make decisions on “critical or serious” health conditions, irrespective of whether providers or patients can independently review those decisions; and those that make decisions on “non-serious” health conditions, but do not allow for independent review of the software’s decisions by patients or providers.

This shift in focus would likely subject to FDA oversight, for example, mortality-prediction tools even when a physician or patient can independently review the tool’s prognoses before making decisions based on them, Gerke suggests. But lower-risk tools, such as general wellness products like asthma alert mobile apps, might not warrant such oversight under this proposal.

Both Congress and FDA can take decisive action to keep pace with the rising tide of AI-based health care products, Gerke concludes.

Patients losing out amid slump in NHS clinical trials, warn top clinicians | Medical research

The state of clinical trials in the NHS is “much worse than it has been in years” with patients losing access to cutting-edge cancer and dementia treatments, one of the UK’s most senior clinicians has warned.

Sir John Bell, the regius professor of medicine at the University of Oxford and a government life sciences adviser, said the UK’s approach needed “a full overhaul, top to bottom” to prevent a collapse in the number of clinical trials being conducted in the NHS.

“I don’t think there’s any doubt that companies are choosing not to evaluate their drugs in the UK,” he said. “The risks [to patients] are much bigger than have been alluded to.”

The intervention comes after the government launched an independent review led by the former health minister James O’Shaughnessy into why the NHS had seen a 44{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} drop in participants recruited to commercial clinical trials in the past five years. The UK is rapidly losing ground to countries such as Spain, Poland and Australia, falling from fourth to 10th internationally for phase III trials.

Prof John Bell.
Prof John Bell says patients get access to groundbreaking treatments and the NHS makes money from conducting commercial trials. Photograph: Sophia Evans/The Observer

Reduced access to trials is particularly concerning for patients with limited routine treatment options, such as the roughly 3.5 million people living with rare diseases and patients with dementia and advanced cancer.

Beyond clinical benefits, the NHS makes money from conducting commercial trials. “You get the drugs for free, you get the treatment for the control arm for free, the NHS rides for free for everyone in the trial and pharma pays pretty well to get these trials done,” said Bell.

However, Bell said bureaucracy that had been simplified during the pandemic to fast-track trials had “crept back into the system and ossified” and the overstretched NHS workforce was losing capacity for research. “The system needs a pretty serious revamp,” said Bell. “[The government] is not going to fix this by just turning the handle a bit harder.”

Official figures show just 52{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of trials in the NHS are running to schedule – a significant improvement in recent months but still some way from the target the Department of Health has set for 80{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} trials being delivered to time and target by June.

The department has directed funders to shut down any trials that have missed their target to start recruiting by more than 90 days, with one in 10 trials being monitored under its Reset Research programme set to close prematurely. Five hundred trials have been closed under the initiative since May last year.

Other senior clinicians also raised concerns. Prof James Rowe, a senior dementia researcher at the University of Cambridge and consultant neurologist, said the UK’s lengthy approvals process could leave clinicians and their patients frozen out of international multicentre trials.

“If it’s going to take you 12 months to get started in the UK, by the time you get the green light the trial is effectively closing for recruitment internationally. It could be futile to begin the work to set up,” he said.

“It’s a great pity as there’s fantastic progress in the dementia world. There are 300 clinical trials for dementia worldwide. The UK should be at the forefront of this, not putting up barriers.”

Prof Paul Stewart, the vice-president (clinical) of the Academy of Medical Sciences and of the University of Leeds, said research tended to be viewed as a luxury rather than an integral part of the NHS’s mission.

“As I reflect on my 40-year career in the NHS, there have always been challenges, but now the crisis has come to a head in terms of a research capacity issue. The current environment is extremely challenging,” he said.

Dr Ian Walker, of Cancer Research UK, said the pandemic continued to “cast a long shadow” over clinical research. “As backlogs for diagnosis and treatment grow, NHS staff face more pressures and protecting time for research is increasingly difficult,” he said. “If this pattern continues, it means slower progress towards brand new treatments for cancer.”

George Freeman, the minister at the Department for Science, Innovation and Technology, said: “Commercial clinical trials are absolutely vital to both our UK life sciences sector and widening NHS patient access to innovative medicines all across the UK. The UK has traditionally been a strong global location for trials, as demonstrated most recently through the groundbreaking Covid recovery trial which was set up in record time and was the world’s largest randomised controlled trial for Covid-19.

“However, our life sciences sector has reported a 44{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} fall in recruitment of patients to commercial clinical trials between 2017 and 2021 – so it is vital that we act to rebuild competitiveness.”