Regulation
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.
The Cardiac Scale monitors patients with fluid management conditions like heart failure and kidney disease.
He's concerned that the acquisition would "provide Amazon with access to enormous tranches of patient data."
The latest clearance is for an algorithm that characterizes how much atrial fibrillation a patient is experiencing over time.
Eko Murmur Analysis Software is a machine learning algorithm that detects and characterizes heart murmurs in adult and pediatric patients.