SmartMonitor battery pack troubles dog Philips Children’s Medical Ventures; maker of GenStrip glucose test strips cited for QS and MDR reg violations; the Portable Exchange Deionization System was labeled to meet the requirements of an outdated ANSI/AAMI standard. Nine quality-related warning letters were listed by FDA from Aug. 12 through Sept. 11.
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
The reason for the correction is that if the device momentarily activates but does not cut or staple tissue, providers can be inadvertently locked out during surgical procedures. When a lockout occurs, additional steps are required to open the device and remove it from tissue.
A recent CDRH Learn module urges medical device manufacturers to report potential shortages early, even outside emergencies, to help prevent disruptions. Recent natural disasters underscore the need for resilient supply chains, and reported shortages may be added to an FDA list.
Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.
The US’ foreign trading partners are not working hard enough to secure bilateral deals, says US President Donald Trump, who will introduce new reciprocal tariffs on Aug. 7. MedTech Europe stresses that patients will suffer if medtech is not excluded from the tariffs.
Philips Respironics has updated instructions for use for three ventilators that were included in a May 2024 recall. The company also added three potential injuries and one death to the original number.
