The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Weight-loss devices startup Allurion Technologies closed a $1.7 million funding round, according to the company’s 1st reported filing with the SEC.
The Wellesley, Mass.-based company is working on a balloon, compressed into a swallowable pill, that expands in the stomach.
The balloon remains in the stomach, creating feelings of fullness, until the patient swallows an non-toxic agent that dissolves the balloon. .
MASSDEVICE ON CALL —Appearing in the New England Journal of Medicine, the study concluded that aggressive surgical treatment, the standard approach for prostate cancer treatment in the U.S., may only be necessary for patients with high-risk diseases.
Removal of the gland barely increased the likelihood for survival in patients with low-risk tumors, researchers found, and surgical removal of the prostate "may be neither necessary nor effective" in many cases.
MASSDEVICE ON CALL: The current corporate tax system is “a ball and chain" dragging down medical device makers’ ability to compete in global markets, AdvaMed president & CEO Stephen Ubl will tell the U.S. House of Representatives’ Ways & Means Committee today.
Ubl will ask members to repeal the 2.3% medical device tax as a 1st step toward overhauling U.S. corporate tax codes.
Healthcare giant Steris (NYSE:STE) is looking to "significantly expand" its presence in the gastrointestinal devices market with the $270 million acquisition of U.S. Endoscopy Group, the company announced this week.
U.S. Endoscopy, which employs about 400 and generated about $70 million in revenue in 2011, designs, manufactures and sells devices and support accessories used in gastrointestinal and urology procedures.
The FDA issued draft guidance this week to officially lower the risk category for implanted blood access devices used during hemodialysis, updating classification of the devices in light of improvements in medical understanding and the agency’s existing practices.
The measure would categorize the devices as Class II, a motion that was initially suggested by the agency’s gastroenterology-urology devices panel in 1981 and has effectively been in practice for many years.
Lap-Band maker Allergan (NYSE:AGN) received a subpoena this month from the Office of the Inspector General for the Dept. of Health & Human Services, the company revealed in an SEC filing.
The troubled weight-loss device has been the subject of federal scrutiny following an FDA statement issued late last year warning advertisers to steer clear of exaggerated and false promises in their ads for Lap-Band.
Patients who have already gone a round with the implanted EndoBarrier weight-loss management implant can double-dip without procedural consequences, according to a new study.
The 1st group of Australian patients received GI Dynamics‘ (ASX:GID) EndoBarrier obesity and Type II diabetes treatment device this week at the company’s newly established center in Melbourne.
The news sent GID shares up 6.7% to $1.11 as of about 3:30 p.m. today.
The FDA will meet over 2 days in May to consider the safety profile of medical technologies intended to help obese patients lose weight.
The federal watchdog agency’s gastroenterology and urology devices advisory panel plans to discuss trial design for clinical studies evaluating the merits of endoscopic and laparascopic weight-loss devices, such as balloons, sutures and bands versus surgical approaches.
The committee will also make recommendations on how much risk is acceptable for what may amount to minor weight loss, what counts as clinically meaningful weight loss and other study parameters.
MASSDEVICE ON CALL — Masimo (NSDQ:MASI) nabbed light-emitting diode-maker Spire Semiconductor LLC for an undisclosed amount in a move aimed at cutting costs, speeding development and spurring innovation.
Spire’s advanced LED technology was spun into a wholly owned Hudson, N.H.-based subsidiary named Masimo Semiconductor, which will develop custom components for Masimo’s devices as well as for biomedical, telecommunications, consumer products and other markets, according to a press release.
MASSDEVICE ON CALL — Medistem Inc. (PINK:MEDS) partnered with Yale University on diabetes treatment using stem cells to generate pancreatic islets from endometrial regenerative cells.
Pancreatic islets effectively treated diabetes in animal models, and Medistem is also studying ERCs as therapy for critical limb ischemia and congestive heart failure, both complications of uncontrolled diabetes.
