AliveDx seeks US FDA 510(k) premarket approval for MosaiQ AiPlex CD multiplex microarray: Eysins, Switzerland Tuesday, February 11, 2025, 12:00 Hrs [IST] AliveDx, an established c ...

U.S. medical device regulations require manufacturers of most class II and a small number of class I devices to file a 510(k) unless they qualify for an exemption. 510(k) is a premarket technical ...

A live and archived webcast of the presentation will be available on “Investors” section of the Pulmonx website at https://investors.pulmonx.com/.

Additionally given a 30-day option to buy up to an extra 975,000 shares at the same price are underwriters. About $49.5 ...

EBR Systems is super confident the US medical gatekeeper will approve Wise, the world's first wireless pacemaker device.

Mustang Bio, Inc. (MBIO), a clinical-stage biopharmaceutical company, Thursday announced the pricing of a public offering of 2.65 ...

Travere Therapeutics shares rose sharply in early trading Tuesday after the biopharmaceutical company said it plans to seek expanded Food and Drug Administration approval of its kidney-disease drug ...

Apple (AAPL) continues to work with Chinese company Baidu to develop AI features for iPhones in China even after bringing in ...

It marks another quarter of growing pains for the company, which is racing to launch new products and recover from the ...

AnaptysBio (ANAB) stock climbs as its antibody therapy rosnilimab meets key goals in mid-stage rheumatoid arthritis trial, ...

Tobacco harm reduction advocates in the Philippines lauded the U.S. Food and Drug Administration’s marketing authorizations ...

Under the approval process, the FDA has 180 days to review a pre-market approval application – applicable for high-risk devices such as Wise. But the clock can stop if the agency has follow-up ...