| | | |  By Casey Ross, Katie Palmer, Mario Aguilar, and Mohana Ravindranath | | | Investigating an FDA program for medtech innovation 
MOLLY FERGUSON FOR STAT In a constantly-growing pool of innovative medical technologies, what does it take to be a “breakthrough”? For the last five years, the FDA’s Center for Devices and Radiological Health has applied its own definition as part of a secretive program to accelerate development and review of devices with the potential to improve care for the sickest patients. But a STAT investigation has shown that while the Breakthrough Device Program has driven significant gains for companies, its ability to drive meaningful improvements for patients is far from clear. “People are trying to say, ‘Well, breakthrough must mean it’s really great, and so we should pay for it, regardless of whatever evidence there is,’ and that’s worrisome,” said Joseph Ross, a physician and health policy researcher at the Yale School of Medicine.
In dozens of interviews with policy experts, regulatory consultants, and health tech companies, Mario and Katie found that financial benefits tacked onto the program after its launch — including the potential for automatic Medicare reimbursement — turned the breakthrough label into a business imperative, dramatically changing the nature of the program as interest surged. There are now more than 650 breakthrough-designated devices, with 213 granted the status last year alone. As some start to reach patients, though, experts warn that they can come to market with more uncertainty than usual. Read the full investigation. | A new tool to track breakthroughs On Friday, after months of questions from STAT about the breakthrough program, the FDA for the first time published a list of 44 breakthrough devices that have received authorization. But there’s far more to learn by tracking the devices while they’re still in development. That’s the goal of the Breakthrough Device Tracker, a new database built by STAT that includes details on more than 400 breakthrough devices. The FDA has granted breakthrough status to everything from the brain-computer interface developed by Elon Musk’s Neuralink to a “smart” baby bassinet that aims to prevent SIDS. | The cost of AI colon cancer screening As AI-enabled screening tests are deployed more widely, one fear is that their availability will lead to overscreening, overdiagnosis, and overtreatment — just like provider-driven screenings have for certain diseases. So a simulation-based study of AI-based colorectal cancer screenings in The Lancet Digital Health put that concern to the test by comparing screenings with and without AI in a hypothetical population of 100,000 people over 50 over their lifetimes. Compared to screening without AI, the systems reduced both colorectal cancer mortality and costs — if projected to the entire U.S. population, saving $290 million and more than 2,000 lives. Now to test the model in real life. | The growing role of AI in healthcare Innovative players are introducing AI tools in healthcare, everywhere from patient care to clinical trial analysis and revenue cycle management. Top investors turn to Tegus to learn where these tools add value by hearing directly from the KOLs who’ve seen them at work. Tegus hosts thousands of 1:1 conversations with top physicians, industry executives, and KOLs, so this primary research is just a click away. See for yourself: download a free report on AI applications in healthcare. | Patient ethics in the era of big data  As regulators and industry continue to push toward clinical research based on “real-world” data, there’s plenty of 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 study subjects when research is embedded into clinical care. In an 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. To move forward, they write, researchers need a new framework for their duties to patients. | Money moves -
In the face of ongoing medical staffing shortages, Clipboard Health, which helps providers book shifts at facilities that need them, announced two rounds totaling $80 million over the last two years. The company plans to use the funds to expand to more cities. -
Click Therapeutics, a maker of prescription digital therapeutics, secured a $15 million loan from Silicon Valley Bank to retire an existing loan from investor K2 HealthVentures and advance its pipeline, which includes interventions for major depression, insomnia, and acute coronary syndrome. -
Remote monitoring device company Blue Spark Technologies announced $40 million in funding led by GT Investment Partners and Aon plc to support marketing of its disposable temperature-tracking patch. -
Data analytics company Palantir announced an expansion of its CDC deal for disease monitoring 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 provider Ahead is shutting down, Bloomberg reports, stopping all services for existing users in two months. The company, which was backed by digital pharmacy platform Truepill, was only founded in 2019.
| New appointments -
After Amazon recently hired Aaron Martin out of the chief digital officer seat at Providence, the health system promoted Sara Vaezy into the role from her position as chief of digital and growth strategy. Simultaneously, Providence named Shweta Ponnappa as chief marketing and digital experience officer. -
Wearable maker Movano, which is developing a wrist-worn blood glucose monitor, appointed Nan Kirsten Forte, executive VP for Everyday Health at Ziff Davis, to its board. | | | Thanks for reading! More Thursday,  | | | | Have a news tip or comment? Email Us | |
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