More than 2,500 people work at the facility, which is Baxter’s largest manufacturing site. The company is still working to fully assess the damage.

Masimo’s leadership transition brings a two-year boardroom feud to a close, but questions remain about the path forward in the wake of CEO Joe Kiani’s exit. Kiani resigned after losing his board seat ...

Fred Moll, founder of surgical robotics firms Intuitive Surgical and Auris Health, participated in in the financing round, along with previous Auris investors.

The Food and Drug Administration has published draft guidance detailing recommendations on biocompatibility assessments of medical devices.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 ...

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 ...

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 ...

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.