The new pump allows patients to customize their diabetes management.
The agency’s intent is to decrease regulatory burden while promoting patient access to products.
The device approvals address critical patient need.
Last year the agency surpassed a 40-year record set in 2017, approving 106 novel devices.
“We don’t know how long the shutdown is going to continue,” says the association’s President and CEO Scott Whitaker.
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 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.
The approval is for transcatheter aortic valve replacement in severe symptomatic aortic stenosis patients.
The agency’s latest announcements are indicative of its focus on risk reduction while promoting innovation.