The agency issued a letter to healthcare providers following a journal study about the potential risk of these devices in patients with a type of peripheral arterial disease.
The companies are finally putting to bed all outstanding patent disputes.
The device can be implanted in babies weighing as little as two pounds.
Mission critical activities, such as device recalls and surveillance related to product safety concerns will continue.
This educational event will help medtech manufacturers learn about one of the most complicated aspects of quality system requirements.
The approval is for transcatheter aortic valve replacement in severe symptomatic aortic stenosis patients.
Here are the most read articles of the year.
Smart technologies will continue to play a big role in advancing decision-making efforts.
Amazon Comprehend Medical uses machine learning to pull important medical information from patient records.
The agency will be improving postmarket surveillance, looking at issues that come up once a device is on the market, and promoting innovation.