The Food and Drug Administration has published draft guidance detailing recommendations on biocompatibility assessments of medical devices. The document, which the FDA released Thursday, is the ...

The American Clinical Laboratory Association welcomed the reprieve but said long-term reform of the Medicare payment system is still needed.

The FDA plans to move the assays from higher-risk class III devices to class II, making them eligible for the 510(k) pathway.

SYLKE® was developed by Dr. M. Mark Mofid, a faculty member of The Johns Hopkins School of Medicine and a practicing plastic surgeon for more than 20 years. Dissatisfied with outcomes, he conducted ...

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 ...

BioBridges has been a trusted partner in the life sciences industry for more than 20 years. With the launch of its new ...

Recalled heart devices often lack clinical testing, researchers found in a study published last week in the Annals of Internal Medicine. Heart devices account for one-third of Class I recalls, the ...

Michelle Brennan was named acting CEO of the patient monitoring company following Joe Kiani’s defeat in a proxy battle with an activist investor.

Siemens Healthineers will integrate its robotic X-ray imaging system with Medtronic’s spine surgery suite. Medtronic and Siemens Healthineers have partnered to expand access to pre- and post-operative ...

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 ...