Food & Drug Administration (FDA)
Medtronic’s Endurant II AUI stent graft wins FDA approval
Updated May 30, 2013, at 7:30 p.m. to correct that approval was granted for the Endurant II Aorto-Uni-Iliac stent graft system.
Medtronic (NYSE:MDT) said the FDA granted pre-market approval for its Endurant II Aorto-Uni-Iliac stent graft to treat abdominal aortic aneurysms and clearance for the Sentrant introducer sheath used with the AUI device.
FDA warns CooperSurgical about Texas manufacturing plant
The FDA issued a warning to CooperSurgical (NSDQ:COO) after inspectors noted violations at the company’s Stafford, Texas, manufacturing facility.
Hansen gains on FDA nod for heart rhythm trial
Hansen Medical (NSDQ:HNSN) won a tentative FDA nod to dramatically scale down a clinical trial of its Artisan catheters paired with the Sensi X robotic system.
Hansen said the new study protocol will make it easier to enroll patients, which is has already started to do. The new study design must still be approved by an independent review board.
Sensus Healthcare wins another indication for melanoma treatment
The FDA granted another indication for Sensus Healthcare‘s topical skin cancer device, for treating keloid scars.
The Danbury, Conn.-based medical device company said its SRT-100 "superficial radiotherapy" product has already won 510(k) clearance from the federal watchdog for treating some skin cancers.
Investors shrug off FDA warning letter for Edwards
Investors seemed unfazed by news of a warning letter from the FDA for Edwards Lifesciences (NYSE:EW) over a Utah cardiac surgery systems plant.
FDA enforcement letter: Preview of U.S. mHealth regulations?
By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration recently issued a letter to Biosense Technologies, developer of the uCheck Urine Analyzer mobile medical application, stating that the firm’s product qualifies as a medical device and must have 510(k) clearance in order to be sold in the US.
Device makers object to FDA’s proposed recall guidance | MassDevice.com On Call
MASSDEVICE ON CALL — The FDA’s recent attempt to clear up confusion about official recall requirements got some negative reactions from members of the medical device industry, among them lobbying group AdvaMed and medical device company Boston Scientific (NYSE:BSX).
How reliable are blood glucose meters? Post-market studies raise concerns
A handful of studies presented at this month’s meeting of the Diabetes Technology Society suggest that blood glucose meters, used by diabetics to regulate blood sugar, may not be as accurate as believed.
Researchers said during the meeting that the same devices that met the 95% accuracy standard required to win FDA clearance frequently fell short in post-market testing.
Docs decry FDA delays that keep new medical devices off the market
U.S. physicians are growing impatient with FDA delays that have some medical devices awaiting market approval in the U.S. long after they’ve already hit the shelves in Europe and around the world.
Such devices include renal denervation systems, transcatheter aortic valve implantation systems and ventricular assist technology, some of which have yet to make it to the U.S.
FDA considers more stringent oversight of blood lancet devices
The FDA is taking a closer look at blood sampling devices to determine whether the technology merits a higher level of regulatory oversight.
Currently classified as class I, blood lancets are only subject to general regulatory control. However, the FDA will host an advisory committee meeting on June 26 to determine whether blood lancets merit class II or class III regulatory status. The committee will offer its recommendation to the FDA based on the scientific data presented.