Category: Food & Drug Administration (FDA)Syndicate content

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.

GE Healthcare lands FDA nod for all-in-one CT

April 15, 2014 by Arezu Sarvestani

FDA regulators GE Healthcare's latest high-def, low-dose CT scanner, which the company calls the 1st that's "right for physicians in every clinical specialty."

GE Healthcare lands FDA nod for low-dose CT

GE Healthcare's (NYSE:GE) this week touted a new FDA win for its latest in CT scanner technology, saying the Revolution* CT^ is the 1st of its kind that's right for "every clinical specialty."

FzioMed turns to FDA's Dispute Panel to contest Oxiplex denial

April 14, 2014 by Arezu Sarvestani

California-based FzioMed lands a Dispute Resolution Panel date with FDA regulators to discuss the Oxiplex spinal surgery gel that the agency denied in 2008.

FzioMed gets a date with the FDA

Once-scorned biomaterials maker FzioMed is getting another day with the FDA to discuss its Oxiplex spinal surgery gel, which was rejected by U.S. healthcare officials in 2008.

FzioMed will meet June 10, 2014, with the FDA's Medical Device Dispute Resolution Panel to discuss the "approvability" of the Oxiplex gel, which has been on the European market since 2012 and is approved for sale in 70 countries. The product has already been used in more than 350,000 surgeries, FzioMed said.

Yet another warning letter for Hospira | MassDevice.com On Call

April 14, 2014 by Arezu Sarvestani

FDA regulators issue a formal warning asking Hospira to provide more information on steps taken to address quality control issues highlighted in previous notices.

MassDevice.com On Call

MASSDEVICE ON CALL — Drug pump maker Hospira (NYSE:HSP) was the subject of another FDA warning letter posted this month, in which FDA officials asked for more information about steps taken to address quality control violations.

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