The Medical Device Business Journal — Medical Device News & Articles | MassDevice
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.
The Food & Drug Administration released a list of pre-market approvals granted in March:
PMA Original Approvals
The FDA launched an effort to cut down on the number of infections that occur from improperly cleaned endoscopes, which the federal watchdog agency says were responsible for more than 28 reports of infections from Jan. 2007 to May 2010.
The FDA said it received more than 80 reports of improperly reprocessed endoscopes during the three-year period. Endoscopes are long, thin tubes fitted with a camera or light that are threaded into the lungs, blood vessels or other cavities to visualize areas within the body.
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.
Boston Scientific Corp. (NYSE:BSX) is touting the U.S. release of its Ion drug-eluting stent system as the first step toward bolstering its leadership position in the DES market.
The Ion paclitaxel-eluting stent, which is built on Boston Scientific’s next-generation platinum-chromium Element platform, won FDA approval for commercial release in the U.S. The stent, already available in Europe under the Taxus Element label, brought in just under $90 million in sales last quarter.
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.
Following a February warning letter from the FDA, Anulex Technologies Inc. has had to adjust by having a round of layoffs.
President and general manager Tim Miller declined to say how many people were let go but acknowledged that such letters were “extremely disruptive to business.”
A new treatment for a deadly form of brain cancer has been approved by the FDA and is cleared for sale in the U.S. market.
The NovoTTF-100A System (NovoTTF) made by NovoCure is a “non-invasive device consisting of four sets of insulated electrodes attached to an electronic box,” according to the privately-held Israeli company.
The FDA released a flurry of recalls for medical devices this week.
First, iCad Inc. (NSDQ:ICAD), formerly Xoft Inc., had to remove a radiation guard for breast cancer treatment, over reports that the device sheds tungsten particles.
The FDA issued the Class I recall for Sunnyvale, Calif.-based company’s Axxent FlexiShield Mini, Model F5300. The Food & Drug Administration issues Class I recalls when there is potential for serious injury or death from use of a particular device or product.
