Category: FDA Updates

FDA Updates

FDA Clears MRI Reconstruction Technology

Hyperfine has received U.S. FDA 510(k) clearance for the launch of its new MRI image reconstruction technology, which utilizes deep learning capabilities.

FDA Updates

FDA Provides Update on Recall of Certain Philips Respironics Breathing Assistance Machines

The U.S. FDA is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) machines.

FDA Updates

How CDRH’s Digital Transformation Initiative Will Strengthen the Premarket Review Program

Through its Digital Transformation Initiative, the U.S. FDA’s Center for Devices and Radiological Health aims to build a more robust, digital infrastructure to optimize the premarket review program for medical devices.

Clearances

FDA OKs Siemens Healthineers CT Scanner

Malvern, Pa.-based Siemens Healthineers announces that the U.S. FDA has cleared SOMATOM X.ceed, a single-source CT scanner that combines high-speed scanning capabilities with a new hardware/software combination to streamline CT-guided interventions.

Recalls

Philips Starts Repair and Replacement of DreamStation Devices

Months after recalling millions of respiratory devices due to health concerns, Philips announced that it would start repairing and replacing its DreamStation CPAP devices in the U.S.

Labeling

Ready for the UDI Enforcement Deadline?

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.

Draft Guidances

FDA Issues Draft Guidance on Remanufacturing, Seeks Feedback on Cybersecurity Servicing of Medical Devices

The U.S. FDA is now accepting comments from the public on the draft guidance, “Remanufacturing of Medical Devices,” and on a discussion paper on cybersecurity servicing of devices.