The Medical Device Business Journal — Medical Device News & Articles | MassDevice
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
