Investigating FDA’s Breakthrough Devices, Big Data Ethics, and AI for Colon Cancer


You’re reading the web edition of STAT Health Tech, our guide to how technology is transforming the life sciences. Sign up to receive this newsletter in your inbox every Tuesday and Thursday.

Investigation of an FDA program for innovation in medical technologies

In an ever-changing pool of innovative medical technologies, what does it take to be a “breakthrough”? For five years, the FDA Center for Devices and Radiation Health applied its own definition as part of a secret program to accelerate the development and examination of devices that could improve the care of the sickest patients. But a STAT investigation showed that while the breakthrough device program has generated significant gains for companies, its ability to generate significant improvements for patients is far from clear.


“People are trying to say, ‘Well, a breakthrough has to mean this is really great, and so we should be paying for it, whatever evidence there is,’ and that’s worrying,” he said. Joseph Rossphysician and health policy researcher at Yale School of Medicine.

In dozens of interviews with policy experts, regulatory consultants and health technology companies, Mario and Katie found that the financial benefits added to the program after its launch – including the potential for automatic Medicare reimbursement – turned the revolutionary label into a business imperative, dramatically changing the nature of the program as interest grew. There are now more than 650 Designated Breakthrough Devices, 213 of which achieved status in the last year alone. However, while some are starting to reach patients, experts warn they may hit the market with more uncertainty than usual. Read the full survey.


A new tool to track breakthroughs

On Friday, after months of questions from STAT about the groundbreaking program, the FDA for the first time published a list of 44 revolutionary devices that have received authorization. But there’s a lot more to learn by tracking devices while they’re still in development. It is the purpose of the Revolutionary device tracker, a new database created by STAT that includes details of over 400 breakthrough devices. The FDA has granted breakthrough status to everything from the brain-computer interface developed by Elon Muskit is Neuralink to a “smart” baby cradle that aims to prevent SIDS.

The cost of AI colon cancer screening

As AI-enabled screening tests are rolled out more widely, there are concerns that their availability could lead to overscreening, overdiagnosis and overtreatment – ​​just as provider-led screenings have done for some diseases. Thus, a simulation based on study AI-based colorectal cancer screenings in Digital Health The Lancet put this concern to the test by comparing screenings with and without AI in a hypothetical population of 100,000 people over the age of 50 during their lifetime. Compared to screening without AI, the systems reduced both mortality and costs from colorectal cancer – if projected across the entire US population, saving $290 million and more than 2,000 lives. Now to test the model in real life.

Patient ethics in the era of big data

As regulators and industry continue to push for clinical research based on “real world” data, there is much talk about how to maintain rigorous standards of evidence in less controlled settings. But there are also critical unanswered questions about how to protect patients who unwittingly become subjects of study when research is integrated with clinical care. In a American Journal of Bioethics article, Stephanie Morain and Emily Largent present complicated case studies in which researchers found information that could help patients – but they didn’t know what to do with it, because the patients didn’t know they were actually subjects. Moving forward, they write, researchers need a new framework for their duties to patients.

money moves

  • Faced with the continuing shortage of medical personnel, Clipboard Healththat helps providers book shifts in facilities that need them, announcement two rounds totaling $80 million over the past two years. The company plans to use the funds to expand to other cities.
  • Click on Therapeutica maker of digital prescription therapies, got $15 million ready from Bank of Silicon Valley to withdraw an existing loan from an investor K2 Health Ventures and advancing its pipeline, which includes interventions for major depression, insomnia and acute coronary syndrome.
  • CCTV company Blue Spark Technologies announcement $40 million in funding led by GT Investment Partners and Aon plc to support the commercialization of its disposable temperature tracking patch.
  • Data analysis company Palantize announced a expansion of his CDC agreement for disease surveillance and response through a platform called Data Collation and Integration for Public Health Event Response. No figures were cited, but the last contract extension in 2021 was worth $7.4 million.
  • Online ADHD Medication Supplier Ahead is closing, Bloomberg reports, stopping all services for existing users in two months. The company, which was backed by a digital pharmacy platform realpillwas only founded in 2019.

New appointments

  • After Amazon recently hired Aaron Martin as Chief Digital Officer of Providencethe health system promoted Sara Vaezy in the role of his position as Chief Digital and Growth Strategy Officer. Simultaneously, Providence appointed Shweta Ponnappa as Director of Marketing and Digital Experience.
  • Laptop Manufacturer Movanowho is developing a wrist-based glucometer, named Nan Kirsten ForteExecutive Vice President for Everyday Health at Ziff Davisto his plank.

What we read


Comments are closed.