Medical Device Industry News

FDA lowers regulatory bar for ingestible sensors

May 17, 2013 by Ingrid Mezo

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.

Direct Flow Medical wins FDA approval for U.S. trial of new heart valve

May 17, 2013 by Ingrid Mezo

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 gains extriCARE CE Mark

May 17, 2013 by Ingrid Mezo

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.