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FDA plows forward with researcher misconduct privacy rule

July 8, 2013 9:29 am | by Mass Device | News | Comments

The FDA this month issued a rule that would keep confidential certain records pertaining to investigations into potential researcher misconduct at the National Institutes of Health, exempting such documents from federal Privacy Act requirements.


Luna Announces Multi-Year Agreement with Intuitive Surgical

July 8, 2013 9:00 am | by Business Wire | News | Comments

Luna Innovations Incorporated (NASDAQ: LUNA), which develops and manufactures new-generation products for the healthcare, telecommunications, energy and defense markets, today announced a multi-year agreement that amends its development and supply agreement with Intuitive Surgical, Inc., (NASDAQ: ISRG), the global leader in robotically-assisted minimally invasive surgical systems.

Life Care Medical Devices Signs Exclusive Agreement with M.E.D. Surgical for the Distribution in Ireland of its Proprietary Keyhole Cup@ Laparoscopic Access Device

July 8, 2013 8:45 am | by The Associated Press | News | Comments

Life Care Medical Devices Ltd., (OTC BB: LCMD), a development stage medical device company today announced that Life Care Medical Devices, Ltd, Ireland signed an exclusive agreement with M.E.D. Surgical, a subsidiary of Sisk Healthcare for the distribution of the Company's Keyhole Cup@ ...


Itamar-Medical Announced Today That the AMA Has Awarded a CPT Category III Code to a Test Performed by Its EndoPATTM Proprietary Device

July 8, 2013 8:00 am | by Business Wire | News | Comments

Itamar-Medical Ltd (TASE: ITAMAR), developer and marketer of the EndoPAT TM non-invasive device for the assessment of endothelial function, today announced that The AMA (American Medical Association) has awarded a CPT category III reimbursement code to a test performed by its EndoPAT proprietary device.


Penumbra, Inc. Launches 5MAX™ ACE—the Newest Clot Extraction Device to Treat Acute Ischemic Stroke Patients

July 8, 2013 8:00 am | by Business Wire | News | Comments

Today, Penumbra, Inc. announced the launch and wide availability of the 5MAX™ ACE, a next generation clot extraction device that uses aspiration alone to engage and remove blood clots causing an acute ischemic stroke. “I’ve used every generation of device for clot removal since the early days, including most recently, the stent retriever devices,” said Blaise Baxter, MD, FRCPC, Director of Interventional Services at Erlanger Hospital.


Varian's Eclipse System Integrates with Elekta Machines for VMAT Treatments at Swiss Cancer Hospital

July 8, 2013 8:00 am | by PR Newswire | News | Comments

Varian Medical Systems (NYSE: VAR), leader in volumetric modulated arc therapy (VMAT) and radiotherapy treatment planning systems, has successfully integrated its Eclipse™ treatment planning system with Elekta linear accelerators to deliver VMAT treatments at Kantonsspital St. Gallen in Switzerland.


Baxano Surgical pays $6M to settle federal healthcare fraud beef

July 8, 2013 7:59 am | by Mass Device | News | Comments

North Carolina medical device maker Baxano Surgical Inc. (NSDQ:BAXS) agreed to pay $6 million to close a Justice Dept. probe initiated nearly 2 years ago. The definitive settlement consummates a tentative agreement the spinal device company forged with federal regulators in December 2012, according to a Baxano Surgical statement.


Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Reporting for Manufacturers

July 8, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

This draft guidance document describes and explains the Food and Drug Administration’s current regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events.


Minnesota’s LifeScience Alley and MedNet join forces, merge memberships

July 5, 2013 1:29 pm | by Mass Device | News | Comments

Medical device manufacturers network MedNet of Minnesota joined forces with medtech trade association LifeScience Alley, merging their membership. St. Paul, Minn.-based MedNet will fold into the St. Louis Park, Minn.-based LifeScience Alley, a lobby group and trade association for the medical device industry.

Vision: Retina Implant AG wins E.U. approval for sight-restoring microchip

July 5, 2013 12:59 pm | by Mass Device | News | Comments

European healthcare regulators this month granted CE Mark approval to Retina Implant AG's Alpha IMS, a tiny eye implant that restores "useful" vision in patients blinded by retinitis pigmentosa. Reutlingen, Germany-based Retina Implant AG, founded in 2003 from a German research institute spinout, touts the technology as "artificial sight."


CorMedix Receives CE Mark for Neutrolin Catheter Lock Solution

July 5, 2013 11:05 am | by Business Wire | News | Comments

CorMedix has announced that it has received CE Mark approval for Neutrolin, a catheter lock solution, for patients with central venous catheters on hemodialysis secondary to advanced chronic kidney disease. The Neutrolin solution includes an anti-coagulant and broad-spectrum antimicrobial combination that is active against common microbes.


Neusoft Medical Signed Transfer Agreement with Philips to Acquire 25% Equities in Philips-Neusoft Medical Systems Joint Venture

July 5, 2013 8:00 am | by PR Newswire | News | Comments

Neusoft has announced that Neusoft's wholly owned subsidiary, Neusoft Medical Systems Co. has signed agreements with Royal Philips Electronics and its affiliate company on the equities and assets transfer, intellectual property rights, contracted manufacturing and supply, components supply, customer service and support of Philips & Neusoft Medical Systems Co.


Revolutions Medical wins $20M libel suit against cyber bully

July 5, 2013 7:59 am | by Mass Device | News | Comments

A South Carolina court awarded medical device company Revolutions Medical and its CEO more than $20 million in damages against Phillip Hicks, an online forum commenter who the company accused of "Internet defamation." Revolutions won $3.6 million in compensatory and $1.5 million in punitive damages.

Microsoft’s growing app market opens doors for mHealth companies

July 5, 2013 7:29 am | by Mass Device | News | Comments

AirStrip Technologies CEO Alan Portela said that the mobile patient monitoring software company is taking notice of Microsoft's new initiative to build its app market for the Surface tablets. Microsoft's new design program, called AppsForSurface, is a chance for AirStrip to take its cardiology and obstetrics apps to the mobile Windows world.


Gandolfini Death Could Have Been Prevented If Hotel Had AED

July 4, 2013 12:55 pm | by PR Newswire | News | Comments

"James Gandolfini absolutely may have survived if hotel personnel had used an AED when they found him," said Dr. Matthew Budoff, an associate professor of medicine at the David Geffen School of Medicine UCLA and a renowned cardiologist, during an interview.



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