Category: FDA Updates

FDA Updates

Stryker Receives FDA Clearance for Bone Tumor Ablation System

Stryker, a medical tech company, announced its OptaBlate bone tumor ablation system (OptaBlate) received 510(k) clearance from the U.S. FDA.

FDA Updates

Philips Respironics BiPAP and CPAP Masks Hit by Recall

Philips has recalled certain masks used with bilevel positive airway pressure machines and CPAP machines due to a serious safety concern.

FDA Updates

Getinge’s Recall of 11,000 Ventilators Labeled Class I Event by FDA

Getinge is recalling several different types of ventilators in its device portfolio that are being labeled as a Class I event by the FDA.

Clearances

Rapid Medical Gains FDA Clearance for Small Thrombectomy Device

Rapid Medical received FDA 510(k) clearance for the TIGERTRIEVER 13 thrombectomy device for large vessel occlusions.

Recalls

Royal Philips Names New CEO Amid Recall Woes

Roy Jakobs is tapped to succeed Frans van Houten as Royal Philips’ president and CEO, effective October 15. Jakobs has been critical in helping Philips address ongoing medical device recall challenges, the company says.

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FDA Issues Draft Guidance on Remanufacturing, Seeks Feedback on Cybersecurity Servicing of Medical Devices

The U.S. FDA is now accepting comments from the public on the draft guidance, “Remanufacturing of Medical Devices,” and on a discussion paper on cybersecurity servicing of devices.