According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...

The US Food and Drug Administration (FDA) has cleared Vent Creativity’s Hermes Knee, an AI-driven software solution for knee ...

The software can determine the extent and severity of coronary plaque build-up implicated in coronary artery disease.

The FDA recently approved the first treatment in nearly 30 years for acute stroke, and the agency also approved a novel drug ...

On December 18, 2024, the Company announced the submission of its 510 (k) premarket notification to the U.S. Food and Drug Administration (FDA) for review and clearance of its Intelligent ...

Sibel Health announced today that it closed a $30 million equity financing and earned its seventh FDA 510(k) clearance.

Lifeward Ltd. announced it has received 510(k) FDA clearance for its latest personal exoskeleton device, the ReWalk 7, which enables individuals with spinal cord injuries to stand and walk.

"Ventripoint has deep experience in the application of AI to echocardiography and this FDA clearance is the culmination of more than two years of research and development," said Ventripoint President ...

powered by artificial intelligence (AI), that can be used to detect skin cancer at the point of care. The eponymous device, the first FDA-cleared skin cancer device for primary care use ...

Sibel Health announces the close of new $30 million dollar Series C financing round led by the Steele Foundation for Hope ...