Ethicon Endo-Surgery Inc. has been granted another review of its Sedasys System by the office of the FDA commissioner, a potential victory for the Johnson & Johnson (NYSE:JNJ) subsidiary and its appeal of the agency’s PMA denial for its sedation system for gastro-enterology procedures.
Gastrointestinal
NinePoint licenses IP trove from Mass. General Hospital
NinePoint Medical Inc. entered into a licensing deal with Mass. General Hospital for 188 patents and patent applications owned by the institution.
The Cambridge, Mass.-based company plans to incorporate the intellectual property into its high-resolution optical imaging platform, an optical coherence tomography-based technology called optical frequency domain imaging for a family of devices for use in cancer detection for the GI tract, according to the company.
FDA committee recommends expanded use for Allergan’s gastric banding weight loss device
Allergan Inc.’s (NYSE:AGN) Lap-Band gastric banding device won a nod from a Food & Drug Administration advisory committee for use on less-obese patients.
The Gastroentology and Urology Devices Advisory Panel, which provides recommendations to the watchdog agency on product approvals, voted 8-2 that the FDA allow doctors to prescribe the Irvine, Calif.-based company’s device for patients with a body mass index of at least 35, or a BMI greater than or equal to 30 along with at least one co-morbid condition, such as diabetes or hypertension.
Covidien lands FDA clearance for surgical stapler
Covidien plc (NYSE:COV) won 510(k) clearance from the Food & Drug Administration for its iDrive surgical stapling system.
The Mansfield, Mass.-based medical products maker designed the device to give doctors better access to the body during colorectal surgery.
Barrx inks Japanese distribution deal
Barrx Medical Inc. signed an exclusive distribution deal with Medico’s Hirata for its Halo gastrointestinal disease treatment system.
Osaka, Japan-based Medico’s Hirata, a medical product supplier, said it is well-positioned to make the Halo device the standard of care in Japan.
California endovascular firms drum up $45 million
California-based EndoGastric Solutions Inc. and Aptus EndoSystems Inc. brought in $30 million and $15 million, respectively, in separate funding rounds.
Menlo Park, Calif.-based Canaan Partners and New York-based Radius Ventures led EndoGastric’s $30 million Series F round, which was designed to support the company through profitability, according to a press release.
BSX study links stenting to lower costs for intestinal treatment
Boston Scientific Corp. (NYSE:BSX) said a study of endoscopic duodenal stenting showed that the procedure reduced the cost and duration of hospital stays by about half when compared to surgical gastrojejunostomy for the treatment of malignant gastric outlet obstruction.
The research used a Medicare database to compare hospitalizations for endoscopic stenting with those for surgical GJ for the disease between 2006 and 2008.
Torax Medical wins CE Mark for GERD device
Torax Medical Inc. won CE Mark approval in the European Union for an implantable device that treats patients suffering from acid-reflux disease.
FDA warns OST again on feeding pumps
The Food & Drug Administration sent another warning letter to OST Medical Inc., accusing the Warwick, R.I.-based firm violating requirements for manufacturing medical devices.
The federal watchdog agency first warned OST in July 2004, after inspections earlier that year revealed "serious regulatory problems” involving its Sentinel enteral feeding pumps. Although the company received 510(k) clearance in 2001, according to the first warning letter, the FDA found that "the device you are currently marketing is not the device described in the premarket notification" OST received in 2001.
medGadget’s MedTech Monday: Historic medical models and devices
Historic medical models and devices: Check out Radio Guy Steve Erenberg’s collection of unusual medical curios, like this mechanical aluminum prosthetic. The collection ranges from orthodontic models resembling Robocop to an antique rubber “death mask” to, well, we couldn’t quite figure out just what that was.
MassDevice Q&A: William Rutan
How do you get people to talk to their doctors about something so embarrassing they’ll barely admit it to themselves?
That’s the challenge facing Greenwich, Conn.-based medical device startup Mederi Therapeutics and the minimally invasive treatment for fecal incontinence it says will eliminate the need for drastic colostomy procedures.