FDA challenge seeks digital tools for addiction treatment
The Food and Drug Administration is calling on device manufacturers and digital health developers to create addiction detection, prevention and treatment products as part of a new innovation challenge. The companies selected will work closely with the FDA to develop and review their product with a “breakthrough device” designation for devices that meet the statutory criteria.
The FDA will be evaluating submissions between June 1 and September 30 and announce the selected applicants in November. Products will be judged based on feasibility and novelty.
“We’re hopeful that in collaborating with public health-minded innovators, we can identify and accelerate the development of new technologies, whether a device, diagnostic test, mobile medical app, or even new clinical decision support software, that can contribute in novel and effective ways to help reduce the scope of this crisis,” FDA Commissioner Scott Gottlieb, M.D., said in a statement. (Release)
Omada Health gains CDC recognition
Omada Health, a digital health company focused on diabetes treatment and prevention, has received full recognition status from the CDC, the largest Diabetes Prevention Program (DPP) providers to achieve the milestone.
To receive full CDC recognition, DPP providers must have their curriculum approved by the federal agency, a minimum percentage of members entering the program with a qualifying blood test and meet a certain threshold of average member weight loss.
“Full recognition is a validation of our proprietary curriculum, our ability to engage and retain participants, and above all, the outcomes we achieve with individuals at risk for type 2 diabetes,” CEO Sean Duffy said in a statement. (Release)
Former ONC head tapped for MedPAC
Former National Coordinator for Health IT Karen DeSalvo, M.D., is one of five new members selected to serve on the Medicare Payment Advisory Commission (MedPAC).
DeSalvo, now a professor of medicine and population health at the Dell Medical School at the University of Texas Austin, was appointed by the Government Accountability Office. She is joined by several other new appointments from Geisinger Health System, HCA and the University of Wisconsin. (Release)
Athenahealth CEO apologizes for past misconduct
Athenahealth CEO Jonathan Bush has apologized for an incident dating back more than a decade in which he physically and verbally attacked his ex-wife.
The statement came after a British tabloid, the Daily Mail, cited 2006 court documents in which Bush admitted to striking his ex-wife in the sternum and giving her a black eye. It comes as Elliott Management has applied increasing pressure on Bush to sell the company.
“I take complete responsibility for all these regrettable incidents involving my dear former wife,” Bush, a nephew of former President George H. W. Bush, said in a statement. “I have worked very hard since then to demonstrate my remorse, and today, Sarah and I have a strong, co-parenting relationship. I accept responsibility for my conduct and apologize to everyone involved.” (Bloomberg)
FDA clears AI tool for wrist fractures
The FDA has approved a device that uses artificial intelligence to detect wrist fractures in adults.
AI software has been identified as a particularly promising tool for image-based specialties. OsteoDetect, manufactured by Imagen, uses “computer-aided detection and diagnosis software” to analyze X-ray images and identify common wrist fractures. The tool is intended as an adjunct to a clinician’s review. (Announcement)