Medtronic Secures FDA Clearance for Next-Gen PillCam Genius SB Capsule Endoscopy System Designed for Home Use
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Recently,Medtronic Receives FDA Clearance for Next-Generation PillCam Genius SB Capsule Endoscopy System
PillCam Capsule Endoscopy has been in use for over 20 years. In late 2021, Medtronic received FDA approval for remote endoscopy using the PillCam Small Bowel (SB) 3 system. The technology is delivered directly to patients, and through telehealth appointments, providers guide patients through the remote procedure.
Over an eight-hour period, the PillCam SB3 capsule safely transmits approximately 50,000 images to the cloud. There, gastroenterologists can evaluate the images to diagnose a variety of conditions, from Crohn’s disease to obscure bleeding to small bowel abnormalities. The patient then returns the data recorder and sensor belt to Medtronic.
The Development and Application of Capsule Endoscopy Resolve Many Common Issues in Traditional Endoscopy. This digestible camera, the primary medical device used during a procedure known as capsule endoscopy, is a small wireless device capable of imaging a patient’s gastrointestinal tract. Capsule endoscopy packages many functions of traditional endoscopy into a swallowable pill form.
The first capsule endoscopy device was introduced by Given, an Israeli company, in 2000. Given Imaging launched the first generation "PillCam™". The capsule device contains several components, including an external capsule, a transparent optical window, LED (light-emitting diode), lens, image sensor, battery, radiofrequency transmitter, and antenna. A receiver carried by the patient collects data transmitted from the pill camera. The information is then processed and stored using a computer with specialized software. The company was later acquired by Medtronic.
PILLCAM™SB 3 Specific Information:
The camera inside the capsule will adjust based on the capsule's movement speed in the small intestine.Capture images at a frame rate of 2 to 6 frames per second (fps).
PillCam™SB 3 System Enables Direct Visualization of the Small Intestine, Offering Greater Confidence in Monitoring Lesions That May Be Associated with Crohn’s Disease, Obscure Bleeding, or Iron Deficiency Anemia. The system features advanced optical and imaging capabilities designed to provide images of the mucosa.
The system includes innovative features such as adaptive frame rate technology, which uniquely supports image acquisition tailored to each patient's movement, as well as the tools required for recording and interpreting study results. The software contains our algorithms, providing you with the necessary tools for effectively reading and interpreting study results.
Technical Advantages:
Adaptive Frame Rate Technology
PillCam™SB 3 System Optimizes Tissue Coverage Through Capsule Endoscopy Technology.
When the system determines that the capsule is moving faster, the image capture rate will change from 2 fps to 6 fps.
The increased frame rate flexibility enhances mucosal coverage and supports tissue acquisition uniquely suited to each patient's motion.
High-quality imaging supports greater diagnostic confidence-In a survey,PillCam™SB 3The clarity of the images provided by the system, natural tissue color, balanced illumination, and overall image quality are100% ofGIHigher than the previous generation of products in all aspects.
Proprietary software algorithms enable smarter video editing with higher efficiency.PillCam™SB 2System High40％。
Raj Thomas, President of Medtronic's Endoscopic Surgery Division, said,“The company has designed new products for use in clinics and at home. This allows patients to undergo procedures in the most suitable location for them. Medtronic's new kit also eliminates the need for data loggers and sensor belts, replacing them with a streamlined linking device."Compared with previous hardware, this improvement makes the surgery more convenient and comfortable for patients."
"For more than 20 years, Medtronic PillCam has been a world leader in the field of capsule endoscopy, impacting the lives of over 4 million patients," Thomas continued, "Now, we are reimagining the experience for our patients with the newly FDA-cleared PillCam Genius SB Capsule Kit for visualizing the small bowel."
Austin Chiang, Chief Medical Officer of Medtronic's Endoscopy division, also posted the FDA approval news on LinkedIn.
"Medtronic PillCam Capsule Endoscopy Is Getting a Major Update!" he wrote. "For 20 years, PillCam has been capturing images of hard-to-reach areas of the gastrointestinal tract for more than 4 million patients.
Jiang said that in the past, patients had to deal with the process of going to the clinic and were equipped with a recording device. Then, they had to return it the next day.
"This device is not only a speed-limiting factor for doctors providing more capsule studies, but it also clearly does not offer an ideal patient experience. Now, the PillCam Genius SB kit will record capsule studies through a sleek adhesive patch, designed for outpatient and at-home use, offering greater comfort, saving patients additional trips to the clinic, and potentially reducing wait times and improving access to care."
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