In the Medical Device Safety Action Plan, FDA regulators set forth ideas for getting safer devices to patients faster.
The FDA's approval process for medical devices has been criticized for years for failing to catch problems with defective implants.
Generic-drug manufacturers, which source most of their active ingredients from China and India, could be hit the hardest by President Donald Trump's proposed tariffs, experts said.
The agency approved marketing a device that can detect diabetic retinopathy by analyzing images of the eye.
U.S. health officials are placing new restrictions on a permanent contraceptive implant that has been subject to reports of painful complications from thousands of women. But the metal implant called Essure will remain on the market.
The U.S. Justice Department settlement involves claims that Alere, which was acquired by Abbott Laboratories last year, sold its Triage-branded devices to hospitals from 2006 to 2012 despite customer complaints warning of erroneous results.
When the Apple Watch was paired with a machine-learning algorithm, it could accurately spot irregular heartbeats, according to a new study.
The CMS will now cover diagnostic laboratory tests using gene sequencing technology for Medicare cancer patients. The agency said the tests can help patients and their oncologists make better treatment decisions.
Though healthcare organizations are spending more on IT, they're suffering more cyberattacks too. Surveyed organizations experienced an average of 16 cyberattacks each in 2017.
The CMS has called off its plan to hasten Medicare coverage for devices. Industry stakeholders say the canceled initiative is a missed opportunity to get seniors the devices they need.
Medical devices that are connected to hospital computer systems create vulnerabilities that can be difficult to manage.
Hill-Rom CEO John Greisch is betting there's more money to be made in blood pressure monitors and retina-scanning devices than adjustable hospital mattresses.