Stryker announces that the company is launching a voluntary field action on specific units of their Lifepak 15 monitor/defibrillators. Specifically, the company is notifying certain Lifepak 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered.
Boston Scientific has received 510(k) clearance from the U.S. FDA for the LUX-Dx Insertable Cardiac Monitor System, a device implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation, cryptogenic stroke, and syncope.
While the second quarter of 2020 started with a dip in recalls, experts predict that the coronavirus pandemic will lead to an eventual spike in medical device recalls once regulators resume their traditional oversight activities.
If your company produces medical or health-related products, you need to know whether they meet the FDA’s definition of Class I medical devices—and, if so, you need to start now to implement UDI Rule requirements before enforcement begins on September 24.
The U.S. FDA has announced that, as a first step toward implementation of the recently established Safety and Performance Based Pathway for medical devices, the agency is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies for four specific types of devices.