Category: Food & Drug Administration (FDA)
The newly FDA-approved Cefaly headband is the 1st device on the U.S. market indicated for preventive treatment of migraine pain.
FDA regulators today announced landmark approval of a mobile headband-like device indicated for prevention of migraines and migraine pain. The device, called the Cefaly system, is the 1st of its kind and is indicated as an alternative to drug therapy.
New York's AngioDynamics wins updated labeling from FDA regulators, indicating its AngioVac venous drainage system for up to 6 hours at a time.
AngioDynamics (NSDQ:ANGO) tallied a new win for its AngioVac drainage system, with new FDA clearance to market the device for extended use.
FDA regulators put their highest-risk label on a recall of Philips Respironics' Trilogy ventilators, pulled over concerns that a faulty component may endanger mechanical breathing support.
MASSDEVICE ON CALL — Philips Healthcare (NYSE:PHG) subsidiary Respironics got the FDA's highest-level warning over a recall of certain Trilogy ventilators.
The U.S. Food & Drug Administration releases a list of 510(k) clearances granted in February 2014.
TOTAL 510(k)s THIS PERIOD 247
TOTAL WITH SUMMARIES 231
TOTAL WITH STATEMENTS 16
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD February 2014
Medtech maker Cardiovascular Systems touts FDA clearance for a 60cm model of its Diamondback 360 peripheral orbital atherectomy system.
Minnesota-based Cardiovascular Systems (NSDQ:CSII) landed FDA clearance for a new size of its Diamondback 360 atherectomy system, used in treatment of peripheral artery disease.
FDA medtech regulators cite a "significant scheduling conflict" in moving EnteroMedics' advisory panel meeting from May to June.
Minnesota medical device maker EnteroMedics (NSDQ:ETRM) announced today that it's May 2014 date the FDA had been bumped a few months back.