Category: Food & Drug Administration (FDA)Syndicate content

Covidien lands FDA OK for camera-equipped feeding tube

April 18, 2014 by Arezu Sarvestani

Covidien touts FDA clearance for its novel camera-equipped Kangaroo feeding tube designed to provide visualization for an otherwise blind procedure.

Covidien lands FDA OK for camera-equipped feeding tube

Medtech titan Covidien (NYSE:COV) received FDA clearance for its visual Kangaroo feeding tube, equipped with an endoscopic camera that allows physicians to see into the procedure in a new way.

FDA warns that breaking up uterine tissue for removal may spread cancer

April 18, 2014 by Arezu Sarvestani

FDA officials warn against the use of "laparoscopic power morcellation" for the removal of uterine tissue or fibroids, saying that the procedure may cause cancer to spread beyond the uterus.

FDA warns that breaking up uterine tissue for removal may spread cancer

FDA officials issued a formal warning today asking doctors to avoid a certain method for removing uterine tissue out of concern that it may cause stealthy cancers to spread beyond the uterus.

Philips takes down Ohio manufacturing following inspection

April 17, 2014 by Arezu Sarvestani

Philips voluntarily suspends manufacturing at an Ohio facility after an FDA investigation turns up "certain issues in the general area of manufacturing process controls."

Philips takes down Ohio PET/CT manufacturing following inspection

Philips Healthcare (NYSE:PHG) halted work at an Ohio manufacturing facility after an FDA inspection turned up some concerns with process controls, a company spokesman confirmed with MassDevice.com today.

Boston Scientific lands FDA approval for next-gen heart devices

April 16, 2014 by Arezu Sarvestani

Boston Scientific gets the FDA's OK for a new generation of defibrillators and heart failure devices, including some of the world's smallest and thinnest ICDs.

Boston Scientific lands FDA approval for next-gen heart devices

Boston Scientific (NYSE:BSX) announced this week that it won FDA approval for its newest suite of cardiac devices, including next-generation defibrillators and heart failure devices.

Another FDA win for Reverse Medical with IDE nod for Barrel vascular device

April 15, 2014 by Arezu Sarvestani

Reverse Medical wins FDA approval to launch U.S. clinical trials of its Barrel vascular reconstruction device for use in treating aneurysms.

Reverse Medical lands U.S. approval to study Barrel vascular reconstruction

California-based Reverse Medical landed key FDA approval to launch U.S. clinical trials of its Barrel vascular reconstruction device for treatment of intracranial bifurcation aneurysms.

The company plans to finalize its trial structure "very soon" and begin enrolling patients within the next few months, president & CEO Jeffrey Valko said in prepared remarks.

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