FDA clears next-gen Medtronic PillCam solution suite

Medtronic (NYSE: MDT)+ officials say the company received FDA clearance for the next-generation PillCam Genius SB capsule endoscopy kit.

PillCam capsule endoscopy has been in use for more than 20 years. Medtronic won FDA clearance for the PillCam Small Bowel (SB) 3 system for remote endoscopy procedures in late 2021. The technology is delivered straight to a patient and, via a telehealth appointment, a provider guides the patient through the remote procedure.

Over the course of an eight-hour procedure, the PillCam SB3 capsule transmits approximately 50,000 images securely to the cloud. There, a GI physician can assess the images to make a diagnosis for conditions ranging from Crohn’s disease to obscure bleeding to small bowel abnormality. The patient then returns the data recorder and sensor belt to Medtronic.

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