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

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 ...

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

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 ...

Nico sells devices for navigating through the brain, visualizing the organ, removing tumors and clots and collecting tissue.

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

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.

Politan Capital Management said its candidates captured two board seats in Thursday’s shareholder vote, citing a preliminary analysis.

Some people are facing delays in filling prescriptions for the glucose sensor. Abbott expects to resolve the problem soon.