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After half a century of serving the regulatory information needs of the pharmaceutical, medical device and biologics communities, FDAnews presents the final issue of its flagship publication today. Read More
A once promising surgical robotics deal with Auris Health has ended in $1 billion in damages for Johnson & Johnson, with a Delaware judge ruling that the healthcare titan failed to honor its end of a bargain involving two of Auris’ novel surgical robot systems, Monarch and iPlatform. Read More
This edition of Quick Notes features announcements of J&J’s acquisition of V-Wave, Paragonix Technologies’ sale to Getinge, Dupont’s purchase of Donatelle Plastics and Stryker’s deal to buy Vertos Medical. Read More
AdvaMed commended CMS for its July 10 proposed rule that includes separate payments for diagnostic radiopharmaceuticals are used to diagnose and treat diseases such as Alzheimer’s and cancer. Read More
A part of an anesthesia system from Getinge that may dispense toxic gas and a cardiac balloon catheter from Teleflex/Arrow that may overtwist during use are both the subject of recalls that the FDA has deemed as Class I, the most serious recall as use of the devices may result in injury or death. Read More
This edition of Quick Notes offers news on medical devices including two continuous glucose monitoring system clearances for Abbott, cybersecurity vulnerabilities for Baxter Welch Allyn, clearance of an AI solution from Heuron to alert of impending intracranial hemorrhage and clearance of an easy-to-use EEG system from Zeto. Read More
Recalled products from Medtronic and Megadyne have been deemed Class I by the FDA — Medtronic for a potential software issue and Megadyne for the potential for burn injuries during surgery. Read More
DexCom’s G7 prescription continuous glucose monitoring (CGM) system now connects directly to Apple Watch for users in the US, making it the first to offer real-time glucose readings so that users can leave their phone behind and still receive timely readings. Read More