Olympus received FDA clearance for its TJF-Q190V duodenoscope that features a single-use endcap and novel flushing adapter that reduce the chance for pathogens to settle between cases. Olympus touts that the new device has a large field of view, a reliable guidewire locking system, and precise handling. Duodenoscopes are used to perform endoscopic (Read more...)
Tag: GI
Light Sensitive GI Devices Break Up on Demand
Most medical devices that are placed within the gastrointestinal tract have to be removed eventually. Such procedures can be challenging to perform and require anesthesia, with all its associated risks and costs. For example, thousands of bariatric balloons are deployed every year and each one of them has to be fished out a few months […]
PENTAX Releases IMAGINA LED Powered Endoscopy System
PENTAX is releasing its IMAGINA Endoscopy System in the U.S., having just received FDA clearance for the GI imaging platform. The endoscope sports two powerful and long lasting LEDs at the tip that do not require regular replacement, unlike traditional bulbs that can be costly to regularly swap for new ones. Given enough procedures, a […]
Wearables, Ingestibles, Invisibles: imec at CES 2020
The Belgian research organization imec has a dear spot in our hearts, as it helps to develop a lot of the technologies that power current and future medical devices (see flashbacks below). At CES in Las Vegas this year, imec’s Chris Van Hoof introduced us to the organization’s somewhat shifting focus toward wearable, ingestible, and, [& (Read more...)
Bioness StimRouter Cleared in Europe to Treat Fecal Incontinence
Bioness, a Valencia, California firm, won European regulatory approval for its StimRouter neuromodulation system to treat fecal incontinence. Previously cleared in the EU as a tool for managing chronic pain and overactive bladder, the new indication significantly expands the stated capabilities of this novel neuromodulation system. For the manageme (Read more...)
Flexible Sensor to Help Diagnose and Treat Swallowing Disorders
Swallowing disorders can be debilitating, even causing nutritional deficiencies in some patients. They can also be difficult to diagnose and require the use of expensive equipment that is only found in select hospitals. Exercises can help those that are diagnosed with certain conditions, but even those exercises require the use of costly devices. R (Read more...)
FDA Clears First Completely Disposable Duodenoscope
A few years ago it was discovered that duodenoscopes, which are used in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures, were bacterial vectors, spreading disease between patients and even causing multiple deaths. This was due to insufficient processing, so some manufacturers put out devices that are easier to clean, while others (Read more...)
Bacterial Hydrogel Adheres to Gut to Treat Inflammatory Bowel Disease
Researchers at Harvard’s Wyss Institute have developed a living bacterial hydrogel that can adhere to lesions in the gut wall to encourage healing and reduce inflammation. Consisting of genetically engineered bacteria that produce nanofibers that adhere to mucus, the resulting hydrogel could function as a novel probiotic therapy for inflammat (Read more...)
PENTAX Medical’s DEC HD Partially Disposable Duodenoscope FDA Cleared
PENTAX Medical is releasing its DEC HD duodenoscope, a high-definition device that uses disposable distal caps and elevator levers, in the United States. The capability to simply throw away the components that tend to harbor bacteria, associated with the transmission of disease and even death, helps to guarantee that there’s little chance of (Read more...)
FDA Clears First Duodenoscope with Disposable Business End
Pentax Medical won FDA clearance for its ED34-i10T2 duodenoscope that features a disposable elevator end piece, making it easier to guarantee that the scope is properly sterilized between patients. This is the first scope of its kind, although we recently covered the clearance of ScopeSeal, a disposable device that snaps over a scope’s busine (Read more...)
Electronic Pill Popping to Detect GI Bleeds: Interview With EnteraSense
Getting a clear view of your GI tract typically involves the uncomfortable process of having a long endoscope snaked down the esophagus. Thankfully, capsule endoscopy technology is replacing many procedures that have required an endoscope. These swallow-able devices are able to withstand the harsh, acidic environment of the gut, and can provide hig (Read more...)
GI Genius Automatically Identifies Possible Polyps During Colonoscopy
At the UEG (United European Gastroenterology) Week event in Barcelona, Spain, the first automatic polyp assistance system was unveiled by Medtronic. The GI Genius intelligent endoscopy system monitors the live video feed from a colonoscope, outlining in real time potential signs of polyps. It certainly doesn’t diagnose anything, but serves, i (Read more...)
GI Genius Automatically Identifies Possible Polyps During Colonoscopy
At the UEG (United European Gastroenterology) Week event in Barcelona, Spain, the first automatic polyp assistance system was unveiled by Medtronic. The GI Genius intelligent endoscopy system monitors the live video feed from a colonoscope, outlining in real time potential signs of polyps. It certainly doesn’t diagnose anything, but serves, i (Read more...)
ScopeSeal, A Snap-on Shield to Keep Duodenoscopes Clean from Infections
ScopeSeal, an Arlington, Virginia firm, has won FDA clearance for the first duodenoscope attachment that helps to protect the imaging end from infections. Duodenoscopes are used in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures. A few years ago it was discovered that they are carriers of infections, because of design flaws and in (Read more...)
Fidmi Enteral Feeding Device Prevents Dislodgement, Lets Patients Swap Inner Tube Themselves
Fidmi Medical, a company based in Israel, won FDA clearance for its new low-profile enteral feeding device. The product is designed to help overcome many of the challenges presented by percutaneous endoscopic gastrostomy (PEG) tubes, especially dislodgements and clogging of the inside. The Fidmi product can be delivered as the initial tube, as well (Read more...)
Using FibroScan in The Clinic: Interview with Dr. Stephen A. Harrison
EchoSens creates non-invasive liver diagnosis medical devices. The company’s line of products, called FibroScan, work by measuring the speed of ultrasound waves as they move through liver tissue. This measurement can tell us about the state of the liver. For example, ultrasound waves move faster through fibrotic/scarred livers. EchoSens recen (Read more...)
Ethicon’s New ECHELON CIRCULAR Powered Stapler
Ethicon, a part of J&J, just unveiled the ECHELON CIRCULAR, which the company touts as the first powered circular stapler specifically designed for colorectal, gastric, and thoracic procedures. The device features so-called “Gripping Surface Technology” that is supposedly more tender on the tissues being stapled, distributing forces (Read more...)
Non-Invasive Liver Assessment: Interview with Echosens’ New CEO Dominique Legros
Echosens is a medical device company based in Paris, France that’s focused on diagnosing liver disease. Their technology, called FibroScan, uses ultrasonic waves to non-invasively measure the elasticity and absorption of the liver. These measurements can inform medical care teams about the amount of scar tissue and fatty content in a patient& (Read more...)
Lumendi Gets FDA Clearance for New Endolumenal Interventional Knife
Lumendi, an English firm, won FDA clearance to introduce its DiLumen Ik endolumenal interventional knife. The single-use monopolar device is used for surgical dissections, performing cuts, and cauterizing of tissues of the gastrointestinal tract. To help perform many procedures that require a section to be elevated from the surrounding tissue, the (Read more...)
NvisionVLE System FDA Cleared to Analyze Pancreas and Bile Duct
NinePoint Medical, based out of Bedford, Massachusetts, won FDA clearance for its NvisionVLE Imaging System to be used in assessing the pancreas and bile duct. The system can image tissue around a catheter tip up to 3 mm below the surface. It does so thanks to a rotating light beam emanating from the catheter as […]