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 ...

Allurion’s CEO confirmed to Medical Device Network that the company has changed advertising, patient follow-up, and physician ...

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 ...

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

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

Shares of Chinese e-commerce giant Alibaba rose in premarket trade after reports it’s partnering with Apple to roll out ...

Shares of Moderna, along with other vaccine makers, dropped further this year as lawmakers advanced President Donald Trump's ...

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

Shares in Moderna came under pressure on Friday, after fourth-quarter losses at the US biotech were bigger than expected.

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

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 ...

Drugmaker Incyte Corp reported fourth-quarter revenue above Wall Street estimates on Monday, boosted by strong demand for its key blood-cancer drug Jakafi and skin-disorder treatment Opzelura.