Category: Gastrointestinal
Gastrointestinal
The Food & Drug Administration issues a warning letter to OST Medical Inc., its second since 2004.
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.
Radio Guy Steve Erenberg's collection of unusual medical curios; anastomosis system uses biodegradable nitinol rings; ingestible robot prowls the GI; and a cochlear hearing aid without the implant.
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. 
The CEO of Mederi Therapeutics on the challenges of increasing awareness of bowel incontinence and his company's minimally invasive alternative to colostomy surgery.
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.
Product(s):
Develops injectable biocompatible products.
Ten morbidly obese patients using the Lexington bariatric device maker's gastrointestinal liner and flow restrictor lost a median amount of nearly 37 pounds.
GI Dynamics is touting the results of a small pilot study of its Endobarrier system that showed significant weight loss in morbidly obese patients.
The system combines the Lexington-based bariatric device maker's flagship gastrointestinal liner, a plastic sleeve that's inserted through the mouth into the intestine to prevent the absorption of nutrients from food, and its latest product, a flow restrictor that limits the amount of food that can pass from the stomach into the gastrointestinal tract.
Product(s):
Manufactures the Cellvizio fibered confocal microscopy system for GI endoscopy, interventional pulmonology and small animal imaging
Product(s):
Develops a bioartificial liver device, HepaLife, to treat liver failure using a patented PICM-19 liver stem cell line; and testing platforms to improve the evaluation of drug toxicity and side effects
Management:
Donna A. Lopolito, CFO
Shawn P. Cain, director-product development
Richard E. Kruger, director-regulatory affairs
