The Essential Resource for the Medical Design Engineering Community
FDA Approves First Single-Lead ICD with Atrial Sensing
February 25, 2013 9:00 am | by The Associated Press | News | CommentsLAKE OSWEGO, Ore.--(BUSINESS WIRE)--Feb 25, 2013--BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced the Food and Drug Administration (FDA) has granted final approval for the BIOTRONIK Lumax 740 DX System. This novel device is a first-in-class implantable cardiac...
University of Michigan's Zell Lurie Institute Awards $112,000 to Promising Student Startups in 30th Annual Business Plan Competition and Dare to Dream Grant Program
February 25, 2013 9:00 am | by PR Newswire | News | CommentsBest Business Focus Receives $20,000 for Physical Therapy Device and Application ANN ARBOR, Mich., Feb. 25, 2013 /PRNewswire-USNewswire/ -- The Samuel Zell & Robert H. Lurie Institute for Entrepreneurial Studies at the University of Michigan's Stephen M. Ross School of...
LabCorp Launches Next Generation Sequencing Assay for Familial Cardiac Disease
February 25, 2013 8:45 am | by The Associated Press | News | CommentsBURLINGTON, N.C.--(BUSINESS WIRE)--Feb 25, 2013--Laboratory Corporation of America ® Holdings (LabCorp ® ) (NYSE: LH) today announced it has launched its clinical next generation sequencing assay, GeneSeq®: Cardio for genetic causes of familial cardiac disease. Familial cardiac diseases are...
CardioDx to Present at Cowen and Company 33rd Annual Healthcare Conference
February 25, 2013 8:30 am | by The Associated Press | News | CommentsCardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced that the company will present at the Cowen and Company 33rd Annual Healthcare Conference on Monday, March 4, 2013 at 10:00 a.m. ET at the Boston Marriott Copley Place in Boston.
Atossa Genetics Receives Warning Letter From the Food and Drug Administration
February 25, 2013 8:30 am | by The Associated Press | News | CommentsSEATTLE--(BUSINESS WIRE)--Feb 25, 2013--Atossa Genetics, Inc. (NASDAQ: ATOS) (“Atossa” or the “Company”) received a Warning Letter (“Letter”) from the FDA on February 21, 2013, regarding its Mammary Aspirate Specimen Cytology Test (MASCT) System and MASCT System Collection Test (together, the...
MetroStar Home Health COO Asks Congress to Cease Round 2 of The Centers for Medicare Services' Medical Equipment Bidding Process
February 25, 2013 8:30 am | by PR Newswire | News | CommentsNEW YORK, Feb. 25, 2013 /PRNewswire/ -- Durable Medical Equipment companies across their country join in the effort to protect Medicare Beneficiaries from devastating changes as a result of new Medicare suggested by The Centers for Medicare & Medicaid Services (CMS).
Ocular Therapeutix Completes PMA Submission for ReSure® Sealant
February 25, 2013 8:00 am | by The Associated Press | News | CommentsBEDFORD, Mass.--(BUSINESS WIRE)--Feb 25, 2013--Ocular Therapeutix, Inc. announced today that it has submitted its Premarket Approval (PMA) Application to the U.S. Food and Drug Administration (FDA) for ReSure Sealant, a novel ophthalmic medical device that utilizes the company’s proprietary...
Implanted Electrodes Can Help Amputees Gain Sensation in Prosthetics
February 25, 2013 7:29 am | by Mass Device | News | CommentsSwiss researchers have a developed a new prosthetic limb system that uses implanted electrodes to send sensory signals from the limb back to the brain, creating a more realistic sense of touch. "We could be on the cusp of providing new and more effective clinical solutions to amputees in the next years," Silvestro Micera, head engineer...
OptiMedica Granted Fundamental Patent on Laser Cataract Surgery by U.S. Patent & Trademark Office
February 25, 2013 7:00 am | by The Associated Press | News | CommentsSUNNYVALE, Calif.--(BUSINESS WIRE)--Feb 25, 2013--OptiMedica Corp. has announced that the U.S. Patent & Trademark Office (USPTO) has granted the company a patent relating to the fundamental technology underlying laser cataract surgery. The OptiMedica patent, which will issue on March 12, 2013...
NxStage Wins Another Nod in the European Union
February 25, 2013 7:00 am | by Mass Device | News | CommentsNxStage Medical won CE Mark approval in Europe for its System 1 technology, which includes new high-flow capabilities to the portable hemodialysis system. The Lawrence, Mass.-based company is gearing up to distribute this product in the European Union later this year.
AirStrip 1 Debuts in Arizona Hospitals
February 25, 2013 6:00 am | by Mass Device | News | CommentsAirStrip 1, the electronic data management system designed to link disparate medical technologies, launched last week with co-developer Dignity Health installing the system at two of its member hospitals in Arizona. Dignity Health, hoping to ease compliance with ACO regulations, increase market share, and expand clinical setting with mobile data access...
Syneron Settles Patent Lawsuit Against EndyMed
February 25, 2013 5:00 am | by Mass Device | News | CommentsSyneron Medical dropped a patent infringement lawsuit against EndyMed Medical and its distributor, Eclipse Aesthetics, after EndyMed agreed to stop selling its fractional skin resurfacing products in the U.S. EndyMed will continue to re-supply electrodes and other maintenance items for the products it has already sold, according to a press release.
Volcano shares dive on lowered guidance
February 25, 2013 4:00 am | by Mass Device | News | CommentsShares of Volcano were down nearly 10% on Wall Street in late-day trading Friday, after the medical device company revised its sales and earnings guidance downwards, a day after a tough 4th-quarter earnings release. The San Diego, Calif.-based firm said it expects to turn 8¢-11¢ earnings per share on $406 million-$412 million in sales.
Class I Medical Device Recall: Lumenis Limited, Lumenis VersaCut Tissue Morcellator
February 25, 2013 12:00 am | by U.S. Food & Drug Administration | News | CommentsLumenis Limited is recalling certain models of VersaCut Morcellator devices to correct its labeling. There is a potential for air embolisms to occur if the aspiration tubing is hooked up backwards to the aspiration control box housing. This product may cause serious adverse health consequences, including death.
FDA Hits Depuy with Class 1 Recall over Joint Sleeve
February 24, 2013 8:35 pm | by Mass Device | News | CommentsJohnson & Johnson subsidiary DePuy Orthopaedics is in hot water again, this time due to a limb preservation system sleeve that's being pulled out of surgery suites in a recall rated Class 1 by the FDA. The diaphyseal sleeve is used to reconnect tissues during joint surgery.
