A quartet of healthcare giants including UnitedHealth, the largest single health insurer in the U.S., joins forces for the SharedClarity project, aiming to leverage their combined Big Data to get the best devices for the best prices.
Although current quality systems are likely sufficient, the FDA should look to lessons learned from recent catastrophes in developing risk mitigation strategies to better protect medical devices and related systems, an agency panel says.
Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com's coverage highlights our seven biggest and most influential stories from the week's news to make sure you're up to date on the headlines that continue to shape the medical device industry.
The FDA lowers the regulatory bar for ingestible event markers, downgrading them from Class II to Class III devices.
Effective today, the FDA is down-classifying ingestible event markers from the more burdensome Class III into Class II (special controls).
An ingestible event marker is a prescription device used to record time-stamped, patient-logged events, the agency noted. The ingestible component links wirelessly through intra-body communication to an external recorder which records the date and time of ingestion as well as the unique serial number of the ingestible device.
The FDA approves Thoratec's pocket controller for its HeartMate II implantable heart pump.
Thoratec (NSDQ:THOR) said it got the go-ahead from the FDA to market its HeartMate II pocket controller.
The pocket controller is designed to support the active lifestyles of patients with HeartMate II left ventricular assist devices, the Pleasanton, Calif.-based medical device company stated in a press release.
Direct Flow Medical wins FDA approval for a U.S. trial of its new transcatheter aortic valve implant.
The FDA granted Direct Flow Medical an investigational device exemption for its transcatheter aortic valve implant, with the medical device company announcing enrollment in its Salus feasibility trial.
The American Orthotic and Prosthetic Assn. sues Medicare and the U.S. Health & Human Services Dept. over reimbursement policies for prosthetic devices.
The trade association representing prosthetic medical device makers filed a lawsuit in federal court against Medicare and the U.S. Health & Human Services Dept. over what it calls "unfair and unauthorized" payment rules.
In a complaint filed in the U.S. District Court for the District of Columbia, the American Orthotic and Prosthetic Assn. alleged that the government is unfairly denying payment to suppliers of prosthetic devices.