By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration will begin requiring manufacturers and sponsors of electrical medical devices to show compliance with the standard ES 60601 3rd Edition starting June 30, 2013.
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration will begin requiring manufacturers and sponsors of electrical medical devices to show compliance with the standard ES 60601 3rd Edition starting June 30, 2013.
The federal sequester is siphoning away part of the funds that the medical device industry is paying for FDA review of new technologies, and that means the agency may not be able to keep all the promises it made in exchange for hiking its user fees.
EnteroMedics (NSDQ:ETRM) said it expects to submit a pre-market approval application to the FDA this quarter for its Maestro rechargeable vagal blocking therapy to treat obesity.
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.
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.
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.
Combat Medical Systems won FDA approval for its atypical tourniquet, designed to prevent deaths from uncontrolled bleeding that most often takes place because of roadside and terrorist bombings.
This is the 1st device of its kind approved to treat unmanageable amputations and pelvic injuries, and it has already been shown to save lives based on limited use on soldiers in Afghanistan and traumatic civilian situations domestically, the company said. Uncontrolled bleeding is the number 1 cause of death in combat.
The FDA today released draft guidance clarifying existing recommendations for how medical device manufacturers can appeal the federal watchdog agency’s decisions on marketing applications.
The draft guidance, which the FDA is asking industry to comment on over the next 90 days, pertains to requests for documentation of rationales for significant decisions and requests for supervisory review of regulatory decisions and actions taken by the FDA’s Center for Devices & Radiological Health.
X-Spine Systems won an FDA nod for its Zygafix facet fusion system, which stabilizes the facet joint using a hollow titanium compression screw and internal bone graft. The device is approved for patients who have failed traditional non-surgical treatments.
The Miamisburg, Ohio-based company is touting the device as an improvement over the Fixcet, which uses a solid titanium compression screw.