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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
Congress needs to put more pressure on agencies like the FDA and the US Patent and Trademark Office (USPTO) to collaborate on fighting patent thickets, the multiple patents pharmaceutical companies file after a drug is already on the market to extend the drug’s period of exclusivity and keep generic alternatives off the market. Read More
The FDA is hamstrung from truly mitigating impending drug supply shortages because the agency can’t get a consistently transparent view into drug manufacturers’ operations, FDA Commissioner Robert Califf told the House Committee on Oversight and Accountability during a nearly five-hour hearing on Thursday. Read More