CapsoVision, Inc., a leader in innovative endoscopic capsule technology, today announced that its award-winning product, the CapsoCam Plus® capsule endoscopy system, has received U.S. Food & Drug Administration (FDA) clearance for remote ingestion. This milestone allows patients to conveniently ingest theCapsoCam Plus capsule from the comfort of their homes under virtual medical supervision, representing a transformative step in enhancing patient accessibility and comfort in diagnostic procedures for small bowel visualization.
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CapsoCam Plus is unique in that it typically does not require a visit to a hospital or clinic – unlike competing capsule endoscopy systems, which require two visits: one for ingestion and another to return the equipment. With the recent remote ingestion clearance by the FDA, eligible patients can now avoid clinic visits entirely. They can ingest the capsule from the comfort of their own home and go about their day without any external data recording equipment. The wire-freeonboardstorage designmakescapsule administration faster andeasier, while streamliningthe workflow for physicians andtheir practices. This convenience makes the CapsoCam Plus system an ideal tool for expanding care through telehealth and reducing the burden on both patients and healthcare providers.
The remote ingestion of the CapsoCam Plus capsule is practiced in medical centers serving patients in remote regions of Canada, with favorable outcomes reported in the literature (Journal of the Canadian Association of Gastroenterology, 2021)(1). And in 2020, CapsoVision received enforcement discretion from the FDA during the COVID-19 pandemic for patients determined eligible for at-home administration intheU.S.Thelabeling addendumpermittedafullyremote capsuleendoscopyprocedure for eligible patients, eliminating the need for in-person interaction between clinic staff and patients. The new FDA clearance allows patients to continue to ingest the CapsoCam Plus capsule beyond the initial flexibility granted during the pandemic.
“WearehonoredtoannouncetheFDA'sclearance tocontinueremote ingestionofCapsoCam Plus,”said Johnny Wang, President and CEO of CapsoVision. “By offering a remote option, healthcare providers can significantly enhance patient convenience and broaden the scope of accessible care.”
This milestone for both patients and physicians is supported by a robust protocol for remote ingestion of the small camera device to ensure the same high standard of care that patients receive in a clinical setting. Study participants reported that the capsule is easy to swallow and preferred by patients² over other capsule endoscopy systems. Patients begin the process with a Risk Assessment Patient Questionnaire to assess any potential risks associated with capsule ingestion. During a scheduled virtual visit, a healthcare providerverifiesthepatient'sreadiness,checksthecapsule packaging,andguides thepatientstep-by-step throughthe ingestionprocess, providingreal-time supervisionto ensure asafe procedure. After ingestion, the provider monitors the patient remotely, with an accompanying adult present to assist if needed. This careful oversight allows patients to undergo capsule endoscopy safely while remaining in the comfort of their homes.
CapsoCam Plus is designed for high-resolution, panoramic visualization of the small bowel mucosa, providingphysicianswith acomprehensive tool to detect abnormalities. CapsoCamPlus stands outas the only capsule endoscopy system with four cameras, capturing a 360degree panoramic view of the small bowel to enhance visibility and diagnostic accuracy. Unlike traditional capsule endoscopes withasingle forward-facingcamerathatcanmissimportantdetails, CapsoCam'scomprehensiveimaging technology minimizes the chance of missed lesions by capturing high-resolution images of the entire small bowel. This advantage allows physicians to examine critical areas of the mucosa more thoroughly, improving visibility and diagnostic confidence.
Inaddition tohigherlesion detection,CapsoCamPluseliminatestheneedforexternalequipment,suchas recorders or sensor belts, which can be inconvenient for patients. With CapsoCam Plus, patients ingest the capsule without being fitted with any equipment, allowing them to continue their daily routines while the capsule gathers diagnostic data within the digestive tract. This streamlined, patient-friendly design reduces anxiety and discomfort, making the experience more comfortable and manageable.
“CapsoVision is completely changing the game by offering 360degree panoramic imaging, providing a comprehensiveviewofthesmall bowel mucosa, combined withtheeaseof useof remote ingestionand streamlined workflows for physicians. This advancement demonstrates our continued commitment to transforming diagnostic accuracy, patient experience, and practice efficiency,” said Doug Atkinson, Senior Vice President at CapsoVision.
Formore informationabout CapsoVision, visitcapsovision.com.
(1)Remote CapsuleEndoscopy:Outcomes andFeasibility (JournaloftheCanadianAssociationof Gastroenterology, 2021). Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC8697548/.
² Comparisonof CapsoCam® SV-1toPillCam® SB2 in the Evaluationof SubjectswithSuspected Small Bowel Disease – 510K Clearance.
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