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

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

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 ...

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

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 ...

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

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

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

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.

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.

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