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The European Commission aims to increase the availability of notified bodies and designate EU reference laboratories as “essential actions” needed to ensure that the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR) can take effect as planned on May 26, 2022. Read More
CellEra has received a warning letter from the FDA for not keeping written records of oral complaints about its drug-treated sterile wound dressings and not establishing a procedure to handle either oral or email complaints. Read More
The European Commission has ordered U.S. companies Illumina and Grail to keep their organizations separate and look into alternatives to Illumina’s planned $8 billion acquisition. Read More
Australia’s Therapeutic Goods Administration (TGA) is suing a medical device importer and its executive officers for the alleged unlawful importation of surgical face masks. Read More
The Advanced Medical Technology Association (AdvaMed) has developed a special code of ethics to govern dealings with healthcare professionals in India. Read More
Regeneron has persuaded the U.S. Patent Trial and Appeal Board (PTAB) to revisit a Novartis patent covering a syringe used in eye injections. Read More
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