The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Increasing numbers of medical device makers will look offshore to introduce new medical technologies unless the FDA can make its 510(k) review process more predictable, according to researchers from Northwestern University.
Cynosure Inc. (NSDQ:CYNO) officials said the company has won international regulatory approval for two of its cellulite reduction systems, including the SmoothShapes laser liposuction device that sucked $40 million out of now-defunct Elemé Medical Inc.
Abbott Laboratories (NYSE:ABT) won aproval from the FDA for expanded use of its RX Acculink carotid stent system.
The expanded indication means the stent system can be used to treat carotid artery disease patients who have a standard risk for complications from carotid endarterectomy surgery, a procedure that entails cutting open a patient’s neck artery and scraping out blockages.
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINALDECISIONS RENDERED DURING THE PERIOD April 2011
DEVICE: VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM
C.R. BARD, INC. 510(k) NO: K110820(SPECIAL)
ATTN: KETI SINO PHONE NO : 401 825 8575
100 CROSSINGS BOULEVARD SE DECISION MADE: 01-APR-11
WARWICK RI 02886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSEOTITE II MODEL XIFOSSXXX
BIOMET 3I, INC. 510(k) NO: K100724(TRADITIONAL)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINALDECISIONS RENDERED DURING THE PERIOD March 2011
DEVICE: TROKAMED MORCELLATOR AND SHAVER
TROKAMED GMBH 510(k) NO: K091010(TRADITIONAL)
ATTN: ANGELIKA SCHERP PHONE NO : 31 206 125626
AMSTEL 320-I SE DECISION MADE: 01-MAR-11
AMSTERDAM NL 1017AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX ECSTASY (MDMA) ASSAY
Boston Scientific Corp. (NYSE:BSX) and Medtronic Inc. (NYSE:MDT) both announced regulatory approvals for new products that will expand their atrial fibrillation treatment offerings.
Natick, Mass.-based Boston Scientific won CE Mark approval for its Blazer open-irrigated, a radiofrequency ablation (RFA) catheter for treating atrial fibrillation and other arrhythmias.
Abbott Laboratories (NYSE:ABT) landed FDA approval for a new testosterone-boosting product.
The company’s AndroGel 1.62% is treatment for male low testosterone levels, also know as hypogonadism, which affects nearly 14 million men in the United States, according to the company.
Biomet Inc. received FDA 510(k) clearance for its new hip replacement device.
Warsaw, Ind.-based company said its Active Articulation E1 dual mobility hip system is an implant option for orthopedic surgeons performing hip replacement surgery.
InfraReDx Inc. added the European Union to its market for the LipiScan IVUS coronary imaging system.
The Burlington, Mass.-based company won CE Mark approval for the device, which employs both so-called "near-infrared" (NIR) spectroscopy and intravascular ultrasound (IVUS) technology to give cardiologists a grayscale image of a coronary artery, along with a map of lipid core coronary plaques within a blood vessel.
MASSDEVICE ON CALL — FDA 510(k) clearances too slack: GAO. The Government Accountability Office claims that the FDA is putting patients at risk by clearing medical devices such as hip replacements and heart defibrillators under the same system the agency uses to approve power wheelchairs, stitches and catheters, reports The Associated Press.
