Category: Endoscopic / Arthroscopic
Endoscopic / Arthroscopic
Lexington, Mass.-based firm says the first six patients out of a 22-person clinical trial have passed the one-year mark and are showing positive results in losing weight and controlling Type II diabetes.
About a third of the 22 obese patients using a gastro-intestinal liner as an alternative to gastric bypass surgery have shown positive results in both losing weight and reducing amounts of glycated hemoglobin one year into a clinical trial, according to GI Dynamics.
The Lexington, Mass.-based firm, which is developing a non-surgical "sleeve" that is placed in the upper intestine, released 12-month results from six of its study group of 22 obese patients with Type II diabetes.
The Food & Drug Administration tells manufacturers they must revise any labeling indicating that their devices can be reprocessed using the Steris System 1 sterilization system.
The Food & Drug Administration is once again making noises about Steris Corp.'s (NYSE:STE) System 1 processor, warning endoscope manufacturers that they must change any labeling indicating that their devices can be reprocessed using the popular sterilizing device.
The Steris System 1 processor is typically used in surgical and endoscope suites for sterilizing and disinfecting medical devices.
In a letter dated Feb. 22, the FDA warned all endoscope makers that they must change the labeling on any devices that state they can be reprocessed using the Steris system and even suggested they add language indicating that "The STERIS System 1 (SS1) is not a legally marketed device."
The Fall River, Mass.-based tissue preservation company will use the cash to file for 510(k) clearance and scale up manufacturing ahead of a planned product launch next year.
NuOrtho Surgical Inc. drummed up another $1 million in financing, in a Series B round raised from private investors.
The Fall River, Mass.-based company, which is developing a probe that uses low-level radio frequencies to smooth and contour frayed or torn knee cartilage, raised $1 million in a March Series A round.
The new round will go toward applying for 510(k) clearance from the Food & Drug Administration and scaling up its manufacturing operations ahead of a planned 2010 launch.
The British orthopedics giant posts $128 million in net profits during the third quarter, despite a 2 percent slide in Q3 revenues.
Smith & Nephew plc's net profits rose 73 percent during the third quarter, despite a slight downturn in revenues, as the company's cost-cutting measures bore fruit.
The British orthopedics giant posted sales of $915 million during the three months ended Sept. 26, down 1.6 percent compared with $930 million during the same period last year.
Despite that slide, third-quarter net profits rose to $128 million from $74 million during Q3 2008, on the strength of SNN's cost-cutting program.
The Food & Drug Administration clears the latest version of the Natick, Mass.-based device giant's WallFlex bile duct stent; BSX begins enrollment in the MADIT-RIT trial examining optimum defibrillator programming.
The Food & Drug Administration granted 510(k) clearance to Boston Scientific Corp.'s latest-generation WallFlex bile duct stent, and the Natick, Mass.-based medical device giant announced a new defibrillator clinical trial.
BSX said the FDA nod toward its WallFlex Biliary RX fully and partially covered stents means all three WallFlex models — the fully covered, partially covered and uncovered versions — are on the market in the U.S. and Europe.
Navis Medical's variable control guidewire system is designed to replace multiple catheters and guidewires with a single device.
MassDevice is liveblogging the MassMEDIC 11th Annual Medtech Investors Conference. We're talking to the officers and executives of some of the hottest under-the-radar medical device firms around, finding out how and why their technologies will separate them from the pack.
Navis Medical's variable control guidewire system is designed to replace multiple catheters and guidewires with a single device.
Officers
Richard Ganz
Physicians in New York used the Marlborough, Mass.-based company's visually-guided laser balloon catheter in an atrial ablation procedure for the first time in a domestic clinical trial.
CardioFocus Inc.'s atrial ablation catheter was used for the first time in a U.S. clinical trial by physicians at The Mount Sinai Medical Center.
The Marlborough, Mass.-based company's device is a visually-guided balloon catheter that uses a rotating laser to ablate the tissue surrounding the pulmonary artery's entrance into the heart, to reduce atrial fibrillation.
