Public Policy
When determining approval for Breakthrough Device designation, the FDA will consider whether the device addresses present health inequities.
David Rosen, a partner and public policy lawyer at Foley & Lardner, discusses the agency's recently wrapped Software Precertification Pilot Program and what it means for the future of digital health regulation.
From hospital closures to physician shortages, provider scarcity is a big challenge when it comes to expanding Medicare Advantage in rural communities.
The company announced a $10 million Series B raise last year.
The company said the clearance will allow more pharma companies to use Tasso+ for decentralized clinical trials.
The tech giant also announces a partnership between YouTube and the Kaiser Family Foundation that aims to help organizations create high-quality informational content on topics like mental health, maternal care and health inequity.
The new tool measures the diameter of the ventricles of the heart to provide the ratio of the maximum right ventricle diameter compared with the left ventricle. That can help indicate pulmonary embolism severity.
In an SEC filing, One Medical parent 1Life Healthcare said both companies had received requests from the agency for more information regarding the deal late last week.
Insurance navigator Fair Square Medicare raises $15 million, AI-enabled prostate cancer care startup Avenda Health scores $10 million, and oncology clinical trial startup Trial Library emerges from stealth with $5 million.
The Visibly Digital Acuity Product uses a touchscreen mobile device paired with a computer to test how sharp a user's vision is at a distance.