Last year, approval of medical devices by the FDA was relatively the lowest since 2013. However, 2023 looks optimistic with AI and machine learning rising. 

This year’s list of approved medical devices by the FDA is a lot similar to last year with medical technologies like Glucose meters, Stimulators, dermal fillers, Lab tests, heart catheters, implants & more. It indicates that technology evolution with demand for minimally invasive or noninvasive procedures is growing at a turbo pace. 

Topping the list in 2023 is Abbott, with 3 of its products getting the green light from the FDA. 

Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems by Abbott is an implanted spinal cord stimulation system built with familiar technology designed to treat long-term (chronic) pain in the trunk or limbs. One of the many advantages of Proclaim Plus and Proclaim XR SCS Systems is that patients can try them out to see how well it works for them before committing to an implanted system. 

The Perclose ProGlide and ProStyle suture-mediated closure system uses stitch (suture) to close openings made in blood vessels during catheterization procedures. The suture stays in place after the procedure to prevent bleeding until the opening heals. With minimized inflammatory response and enhanced patient experience, the FDA has completely approved this product.

TactiFlex Ablation Catheter, Sensor Enabled, is the world’s first ablation catheter designed with a unique flexible electrode tip and contact force sensing to treat patients with atrial fibrillation. Unlike the existing catheters, the TactiFlex catheter uses a tip design with a laser-cut pattern that flexes when in contact with the heart wall and is specifically designed to be used with Abbott’s EnSite X EP System. 


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