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MedCity News

Mayo health care, coming to a mall near you?

August 5, 2011 By MedCity News Leave a Comment

Mayo Clinic

Next week, an unlikely Mayo Clinic location will pop up as the venerable institution continues down the path of engaging with consumers.

On Aug.11, visitors to the Mall of America will be able to stroll through a 2,500-square-foot space that is designed to be a cross between a high-tech retail store like Apple or Microsoft and an interactive library of Mayo Clinic health information that focuses on health and wellness.

Filed Under: Health Information Technology, News Well Tagged With: Mayo Clinic

Medtronic’s controversial Infuse bone graft goes to Yale

August 4, 2011 By MedCity News Leave a Comment

Medtronic

Medtronic Inc. (NYSE:MDT) announced Wednesday that it is offering a $2.5 million grant to Yale researchers who will independently review the safety of the company’s controversial Infuse bone graft product.

The funds will cover two reviews of the so-called recombinant bone morphogenic protein-2 (rhBMP-2) product, which stimulates bone formation. Yale expects to complete the reviews in six months.

Filed Under: Legal News, News Well, Research & Development, Spine Tagged With: Yale University

Shuren to Minn. device industry: Reviewers will undergo training

August 3, 2011 By MedCity News Leave a Comment

FDA

FDA director of the Center for Devices & Radiological Health Jeffrey Shuren promised medical device makers at a St. Paul, Minn., gathering that the agency would launch its first reviewer training and certification program, aimed at alleviating long-running concerns about inexperienced application reviewers and frequent application turnover.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: 510(k) reforms

Ohio State gets $1.1 million grant for knee replacement research

August 3, 2011 By MedCity News Leave a Comment

Ohio State

Ohio State University researchers have received a $1.1 million federal grant to study the differences in outcomes in patients who have undergone total knee replacement operations.

The research will explore potential causes for the gap between some knee replacement patients who struggle to perform daily tasks, such as climbing the stairs, and other patients who are able to resume activities like hiking and tennis after their operations, according to a statement from Ohio State.

Filed Under: Implants, News Well, Research & Development Tagged With: Knees, National Institutes of Health (NIH), Ohio State University

FDA, Minnesota device industry to collaborate on regulatory science

August 3, 2011 By MedCity News Leave a Comment

FDA

At the close of his two-day visit to Minnesota, Dr. Jeffrey Shuren, director of FDA’s Center for Devices & Radiological Health, announced that a new public-private partnership will be formed with trade group LifeScience Alley in efforts toward developing regulatory science, a set of tools and methods for evaluating the safety, effectiveness, quality and performance of medical devices.

"As a country we don’t invest in regulatory science as opposed to basic science or translational science," Shuren said.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: Medical Alley

Parkinson’s disease monitoring is in Great Lakes NeuroTech’s spotlight

August 3, 2011 By MedCity News Leave a Comment

Great Lakes NueroTechnologies

A Cleveland startup is looking for strategic partners for its web-based systems that assesses the severity of Parkinson’s disease symptoms and helps doctors better tailor medications to people with Parkinson’s.

Great Lakes NeuroTechnologies has been around since 2006 as a division of Cleveland Medical Devices, but was spun off earlier this year as a stand-alone company to focus on movement disorders.

Filed Under: Diagnostics, News Well Tagged With: Cleveland Clinic, Great Lakes NeuroTechnologies, Parkinson's disease

AtriCure expects FDA clearance of new cryoablation system next quarter

August 3, 2011 By MedCity News Leave a Comment

Atricure

Cardiology medical device maker AtriCure Inc. (NSDQ:ATRC) expects to receive U.S. regulatory clearance for a new cryoablation system by the end of next quarter.

The company’s cryoICE BOX system would use extreme cold to freeze cardiac tissue in order to correct abnormal electrical signals that cause heart arrhythmia.

Filed Under: News Well Tagged With: AtriCure Inc.

Medtronic gets FDA nod to test MRI-friendly pacemaker

August 1, 2011 By MedCity News Leave a Comment

Medtronic

The FDA granted Medtronic Inc. (NYSE:MDT) the go-ahead on a clinical trial to test its next generation of MRI pacemaker technology, the company announced today.

The Minneapolis, Minn.-based med-tech giant can enroll up to 250 patients in 50 medical centers across Europe, Central Asia, the U.S., Canada and Australia to test its new Advisa SureScan pacing system, Medtronic spokeswoman Wendy Dougherty said.

Filed Under: Implants, News Well, Research & Development, Structural Heart Tagged With: Boston Scientific, Clinical Trials, stjudemedical

FDA warning: Surgical electrode cap company a wag of the finger

July 29, 2011 By MedCity News Leave a Comment

ECI

A company that makes electrode caps used to monitor brain activity during surgery has received a warning letter from the U.S. Food and Drug Administration.

The warning letter to Eaton, Ohio-based Electro-Cap International cited violations primarily involving the documentation of manufacturing and design processes.

Warning letters are considered by the FDA to be informal and advisory, and don’t necessarily indicate that the FDA intends to take any punitive action against recipients.

Filed Under: Neurological, News Well Tagged With: Electro-Cap International, Warning Letter

INC Research: No acquisitions in near future but CEO says ‘never say never’

July 29, 2011 By MedCity News Leave a Comment

INC Research

INC Research’s Kendle acquisition vaulted the North Carolina clinical research organization into the CRO industry’s top five and, according to CEO James Ogle, helped the company become a global player.

Filed Under: Mergers & Acquisitions, News Well Tagged With: INC Research Inc., Kendle International Inc.

New hypertension treatment from St. Jude Medical? STJ’s CEO stays coy

July 24, 2011 By MedCity News Leave a Comment

J.P. Morgan analyst Michael Weinstein was hoping to get some more information about St. Jude Medical (NYSE:STJ) Wednesday.

Instead, he was greeted by a simile.

Filed Under: Business/Financial News, News Well Tagged With: Renal, stjudemedical

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