The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Weight-loss devices maker GI Dynamics (ASX:GID) announced a couple of new wins in recent weeks, tallying new reimbursement coverage from healthcare officials in Israel and the Netherlands.
California medical device maker EndoGastric Solutions agreed this month to pay $5.3 million plus interest to settle Justice Dept. allegations that the company engaged in Medicare fraud and illegal kickbacks to promote its EsophyX acid reflux disease treatment device.
Israel-based Given Imaging is on a roll, landing Japanese regulatory approval for its 3rd-generation PillCam technology, a swallow-able camera designed to help diagnose gastrointestinal disease.
MASSDEVICE ON CALL — Massachusetts medical device giant Boston Scientific (NYSE:BSX) handed an unrestricted, 3-year $600,000 grant to the American Gastroenterological Assn. in support of ongoing research in GI technology research and education, the AGA announced yesterday.
The FDA recommended bumping blood access devices down from Class III to Class II regulatory status, based on mounting evidence that these implanted tubes, catheters and cannulae belong in a lower-risk category.
The federal watchdog agency said there’s enough safety and efficacy data to peel off a layer of regulatory oversight. Unlike the highest-risk Class III category, Class II devices are subject special controls, such as labeling rules and performance standards, but are exempt from the FDA’s stringent pre-market approval protocol and its attendant clinical trial requirements.
San Clemente, Calif.-based ReShape Medical closed pivotal trial enrollment for its ReShape Duo non-surgical weight-loss system, the company announced this week.
ReShape’s Duo system is comprised of dual intra-gastric balloons that are placed in the stomach non-surgically via an endoscope inserted into the mouth. The balloons takes up space in the stomach to help patients feel full faster, causing them to eat smaller portions.
Medical device maker GI Dynamics (ASX:GID) touted newly published clinical trial data demonstrating that its EndoBarrier gastrointestinal implant can help control blood sugar levels as well as lower cholesterol in patients with Type II diabetes who are only "mildly obese."
MASSDEVICE ON CALL — Gastric banding proved an effective means of treating obesity long-term, according to a 15-year study conducted by Australian researchers at Monash University.
The study was the longest of its kind yet reported, and found that the 10-year follow-up group of patients lost and kept off on average nearly half of their excess weight.
MASSDEVICE ON CALL — A plastic pill-sized camera developed by researchers at Massachusetts General Hospital can capture images of the upper gastrointestinal tract, catching tissue from the surface and up to 10 microns deep as a means of searching for cancer, Medgadget reported.
Irish medical device maker Crospon entered the gastroenterology market with FDA clearance to expand its EndoFlip imaging device to esophageal procedures.
The EndoFlip device is a functional lumen imaging probe used to measure the dimensions and function of hollow organs.
The system was previously cleared for use in during gastric band and sleeve gastrectomy bariatric surgery.
