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A federal appeals court handed another win to Axonics in its ongoing battle with Medtronic over claims that Medtronic’s patents for a sacral-nerve stimulation device are invalid. Read More
Cybersecurity patches — both proactive to address potential threats and reactive to respond to threats that have already occurred — can be expected to be part of any connected device’s lifecycle. But in the medical device world, these patches constitute design changes, which are strictly regulated, says Eric Henry, a senior quality systems and compliance adviser in the law firm King & Spalding. Read More
The center has received more submissions for novel devices over the past twelve months than during any 12-month period since the FDA began tracking in 2015. Read More
Pharmaceutical and medical device companies should not be held liable for terrorist actions after providing medical products to the Iraqi government, says an amicus brief from the U.S. Chamber of Commerce and PhRMA filed to the U.S. Supreme Court. Read More
The company says customers should return any inventory that is not implanted and report any adverse reactions or quality problems to Abbott or the FDA. Read More
Only 28 out of 64 medical device and diagnostic technologies, or 44 percent, requiring new Medicare coverage received reimbursement from 2016 to 2019, with the median time to at least nominal coverage taking 5.7 years, according to Stanford University researchers. Read More
CDRH is accepting and holding in-person meetings with stakeholders and also offering hybrid in-person and virtual – meeting options, Director Jeff Shuren said in a statement Wednesday updating the industry on its return to post-COVID normalcy. Read More
Quidel Cardiovascular’s recall of Quidel Triage Cardiac Panels, used to diagnose a heart attack, has been deemed class I by the FDA, the most serious type of recall as use of the device may cause injury or death. Read More
The FDA is accepting proposals to host in-person or remote visits to allow CDRH staff the opportunity to gain real-world knowledge through the CDRH Experiential Learning Program (ELP). Read More
Abbott announced that it is withdrawing all of its Trifecta heart valves from the U.S. market and removing the remaining inventory from the field due to early structural valve deterioration (SVD). Read More