Last year the agency surpassed a 40-year record set in 2017, approving 106 novel devices.
A recent paper released by Duke University cites the promise of AI, but urges policy changes in order to bring AI-enabled clinical decision software to fruition.
The disgraced former CEO once oozed total confidence about her company and product, and in latest released footage says “I don’t know” more than 600 times during a 2017 deposition.
“We don’t know how long the shutdown is going to continue,” says the association’s President and CEO Scott Whitaker.
The challenges will continue to keep medtech manufacturers and other stakeholders in the healthcare industry on their toes.
From farming to teaching to firefighting, there are many principles of non-medtech professions that can be applied to EU MDR implementation.
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.
It’s time to address this healthcare problem.