News We’re Watching: ReCor And Medtronic Head To RND Panel, Clearances For Anika And Sequel, ZimVie And Brainlab Partner
Executive Summary
This week, the US FDA geared up for a renal denervation panel meeting; a microbiology panel meeting was announced; and a hyaluronic acid patch to promote rotator cuff healing, a novel spiral tampon, and a tibial neuromodulation device to treat incontinence all won FDA clearance.
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Cardio Catch-Up: Advisory Panel Gives Recor Momentum Toward US Launch Of RDN System
The majority of FDA’s circulatory systems devices panel agreed that ReCor’s Paradise ultrasound renal denervation system offers a safe and effective therapy for patients with hypertension. The panel’s endorsement means ReCor will likely be the first company to reach the US market with an RDN system.
News We're Watching: Renal Denervation Trial Highlights, TAP Pilot Update, Cardiohelp Safety Alert
Two new studies support ReCor’s Radiance Ultrasound Renal Denervation System, and renal denervation also won the backing of European medical societies. Additionally, the FDA issued an update on the Total Product Life Cycle Advisory Program (TAP) “soft” pilot, and a disposable component of the Getinge/Maquet Cardiohelp system was flagged for possible sterility issues.
Updated GUDID Data Shows Product Details For 4M Devices
The FDA recently released an updated set of data drawn from devices in the GUDID database, which now includes almost 4 million products.