To promote consistency and reliability in analytical chemistry studies for premarket submissions, the FDA shared recommended approaches for device biocompatibility analysis.

Older medical devices with unsupported software pose cybersecurity threats that regulators and industry are struggling to solve. Here are four steps experts say can help mitigate risks.

Stryker CEO Kevin Lobo said the company had a “very active deal pipeline” on an earnings call in July. The focus was on smaller acquisitions and fast-growing assets, Lobo said. The Nico buyout is the ...

PET radiotracers facilitate the visualization of amyloid plaque density, enabling clinicians to assess people with cognitive impairment for Alzheimer’s and evaluate their response to treatment.

The proxy victory for Politan means the activist investor, with a 9% stake in the company, now controls four of six seats on Masimo’s board of directors. Politan nominees Darlene Solomon and William ...

Some people who use a Freestyle Libre 3 glucose sensor are facing delays getting their prescriptions filled. Abbott spokesperson Lindsy Delco said the delays are driven by strong demand for the Libre ...

A California jury ruled on Wednesday that Axonics did not infringe three of Medtronic’s patents related to sacral neuromodulation. The latest decision resolves a lawsuit that has been ongoing since ...

Merit Medical Systems has struck a deal to buy Cook Medical’s lead management portfolio for about $210 million in cash, the companies said Tuesday. The portfolio includes medical devices and ...

In April, a Securities and Exchange Commission filing revealed that Wojcicki planned to take the company private. 23andMe’s stock price had fallen below $1 per share at the time, down from its $10 ...