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Although unanimously endorsing the safety of Medtronic’s Symplicity Spyral Multi-electrode Renal Denervation system, members of the FDA’s Circulatory System Devices Panel were split on both the efficacy and risk/benefit balance of the ultrasound-powered device, intended to treat hypertension by ablating sympathetic nerves in the renal arteries. Read More
Philips says it has no reports of harm from this issue and has provided instructions to follow until the company can inspect the device, which may continue to be used. Read More
Apellis Pharmaceuticals’ safety probe into reports of retinal vasculitis linked to its eye drug-device combo Syfovre (pegcetacoplan) has discovered that the culprit is likely the company’s injection kits, not the therapy itself. Read More
Intarcia Therapeutics will continue its seven-year quest for FDA approval of its drug-device diabetes treatment with an alternative form of hearing — a public hearing before an advisory committee on Sept. 21to discuss CDER’s refusal to approve the product. Read More
Upcoming events in the coming weeks include seven FDA advisory committee meetings as well as the the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, and webinars from FDAnews, a WCG company on medical device risk management tools and calculating sample sizes for verification and validation activities. Read More
An FDA advisory panel has endorsed ReCor Medical’s novel ultrasound renal denervation system, agreeing unanimously that it’s safe for use in adults with uncontrolled or inadequately controlled hypertension, although the 12 voting members disagreed about how effective the ReCor Paradise system will be in the long run. Read More
Should the FDA get the 11 percent increase in funding that it’s gunning for from Congress, a large chunk will be spent improving internal data quality at the agency, said FDA Commissioner Robert Califf on Tuesday. Read More
Philips has issued an urgent field safety notice for certain of its imaging systems for a potentially faulty foot switch that may lead to unintended radiation. Read More
The FDA’s Circulatory System Devices Panel will review premarket applications for two investigational renal denervation devices this week, both designed to help control refractory hypertension by ablating some of the sympathetic nerves that wrap around the renal artery. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More