Regulation
The Patent Trial and Appeal Board determined three AliveCor patents regarding the detection of heart conditions like cardiac arrhythmias were unpatentable.
EchoGo Heart Failure, developed in partnership with the Mayo Clinic, helps physicians detect heart failure with preserved ejection fraction.
The Israeli startup said it's now focused on receiving clearance to use its AEYE-DS system with a portable camera.
Elizabeth Holmes, founder of the scandal-ridden blood-testing startup, was found guilty on four of eleven charges in January.
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.
The company said the clearance will allow more pharma companies to use Tasso+ for decentralized clinical trials.
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.
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.