FDA clears Medtronic’s PillCam system for remote endoscopy procedures

Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its PillCam Small Bowel 3 system for remote endoscopy procedures.

PillCam SB3 @Home program works with Amazon logistics to ensure timely and accurate results for patients undergoing remote endoscopy procedures from the comfort of their own homes, according to a news release.

The platform offers a telehealth option for the direct visualization and monitoring of the small bowel. Medtronic said it helps to better detect lesions not detected by upper and lower endoscopy that may indicate Crohn’s disease, locate obscure bleeding or identify sources of iron deficiency anemia (IDA).

PillCam SB3 is delivered straight to a patient and, via a telehealth appointment, a provider guides the patient through the remote procedure. Over the course of the eight-hour procedure, the PillCam SB3 capsule transmits approximately 50,000 images securely to the cloud where they can be assessed by a GI physician to make a diagnosis. The patient returns the data recorder and sensor belt to Medtronic once the procedure is complete.

The SB3 @Home platform previously held temporary FDA approval during the National Public Health Emergency, while Medtronic’s PillCam capsule endoscopy has been in use for more than 20 years. PillCam SB is now in its third generation and only holds clearance for remote use in the U.S. and not in other geographies.

“As the future of medicine continues to move toward remote settings, we have great opportunity to deliver diagnostic testing and other minimally invasive procedures from patients’ homes,” Medtronic Gastrointestinal Business President Giovanni Di Napoli said in the release. “The pandemic necessitated more remote innovation, and our capabilities have exceeded expectations to provide better quality care to patients without the risk of COVID infection and without adding to the burden on the medical staff. PillCam SB3 @Home offers a convenient option for a contactless procedure and helps ensure that patients can access care in a timely manner.”

Original Article: (https://www.massdevice.com/fda-clears-medtronics-pillcam-system-for-remote-endoscopy-procedures/)