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.

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

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 ...

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

Ross Segan was chosen to lead the office, which handles premarket authorizations and recalls, in the agency’s Center for Devices and Radiological Health.

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

Just 30 of 157 heart devices with Class I recalls underwent premarket clinical testing, according to a study published in the Annals of Internal Medicine.

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

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.