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Israel-based BrainsGate’s ischemic stroke treatment device will face a vote of the FDA’s Neurological Devices Panel of the Medical Devices Advisory Committee, which will meet on Dec. 10 to decide whether to recommend that the agency approve the company’s premarket application. Read More
The FDA has called on breast implant manufacturers to include a Boxed Warning that the products carry significant risks, among other new labeling requirements aimed at improving transparency for those considering the implants. Read More
The FDA’s Centers for Devices and Radiological Health (CDRH) has released a list of priority guidances it plans to publish during fiscal 2022 — including final guidances on remanufacturing and Unique Device Identification, and several draft guidances on software and cybersecurity. Read More
Australia’s Therapeutic Goods Administration (TGA) plans to require healthcare providers to report medical device adverse events and is inviting public comments on the proposal detailed in a discussion paper. Read More
Devices that use artificial intelligence and machine learning should undergo testing that demonstrates their performance during clinically relevant conditions, the FDA, Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency advised in a joint document on good machine learning practice (GMLP) released yesterday. Read More
Databazaar of Miramar, Fla. drew a warning letter from the FDA for marketing KN95 masks as providing protection against COVID-19 without marketing approval, clearance or authorization from the agency. Read More
The Justice Department has been going after “promoters” who fraudulently convince healthcare providers to bill the federal government for electro-acupuncture, or who market peri-auricular stimulation (P-Stim) devices using that as a selling point. Read More
The notified bodies that certify medical devices with a CE mark in the European Union are concerned that the EU may end up over-regulating the industry through its proposed regulation on artificial intelligence (AI). Read More
Scrambling to clear COVID-19 testing backlogs that have persisted all year, the Biden administration has disbursed more than $562 million to stimulate manufacturing and distribution of the kits over the next two years. Read More