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FDA Approves of Revolutionary AI Device for Colonoscopy

FDA Approves of Revolutionary AI Device for Colonoscopy

The U.S. Food and Drug Administration (FDA) announced de novo clearance of GI Genius™, a revolutionary AI device for colonoscopy. The device is the first of its kind, and was developed by Cosmo Pharmaceuticals, with exclusive distribution rights to Medtronic....
FDA Grants 510(k) Clearance for Respinova’s Pulsehaler

FDA Grants 510(k) Clearance for Respinova’s Pulsehaler

The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for Respinova to market their device that clears secretions for patients with respiratory issues by facilitating the opening of airways. The device, called Pulsehaler, is the first to use patented...