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.
UPDATED May 17, 2013 with comment from Tryton CEO Shawn McCarthy.
Tryton Medical said it got the green light in Europe for its side-branch short coronary stent to treat bifurcation lesions in large vessels.
The new stent is 15mm, 3mm shorter in the main branch zone than the standard Tryton side-branch stent, the Durham, N.C.-based medical device company said.
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.
Devon Medical today launched its portable extriCARE 2400 Negative Pressure Wound Therapy system at the European Wound Management Association conference is Copenhagen, Denmark, after it won CE Mark approval in the European Union.
"The extriCARE system has proven itself in the U.S. as a powerful device that healthcare professionals can rely on for the management of non-healing wounds, including diabetic ulcers and chronic, acute, traumatic, subacute, and dehisced wounds," Devon Medical founder and CEO Dr. John Bennett said in a press statement.
The FDA today released draft guidance clarifying existing recommendations for how medical device manufacturers can appeal the federal watchdog agency’s decisions on marketing applications.
The draft guidance, which the FDA is asking industry to comment on over the next 90 days, pertains to requests for documentation of rationales for significant decisions and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.
Telcare this week got the green light to market its cellphone-enabled blood glucose meter in the European Union, the Bethesda, Md.-based company announced.
The device, the first FDA-cleared mHealth glucose meter, connects patients and caregivers in real time with actionable data, according to a press release.