Category: Food & Drug Administration (FDA)Syndicate content

X-Spine wins FDA clearance for spinal fusion system

May 16, 2013 by Sony Salzman

The FDA gives X-Spine the green light to begin distributing its Zygafix facet fusion system for patients who have failed traditional non-surgical treatments.

X-Spine

X-Spine Systems won an FDA nod for its Zygafix facet fusion system, which stabilizes the facet joint using a hollow titanium compression screw and internal bone graft. The device is approved for patients who have failed traditional non-surgical treatments.

The Miamisburg, Ohio-based company is touting the device as an improvement over the Fixcet, which uses a solid titanium compression screw.

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FDA warns of stolen, unsterilized Covidien surgical staples

May 8, 2013 by Sony Salzman

The FDA warns hospitals to watch out for 1 lot of Covidien surgical staples that are labeled “sterile” but were stolen prior to undergoing sterilization.

Covidien

FDA regulators warned healthcare providers this week that thieves had gotten away with 1 lot of Covidien's (NYSE:COV) Endo GIA Articulating 60-3.5 Surgical Stapler Reloads.

In addition to being stolen, the devices were labeled " ready for use" but were taken before the staples were actually sterilized, the FDA warned. . The agency's Office of Criminal Investigation is looking into the theft.

Honoring an FDA champion of safe treatments for children

May 8, 2013 by MassDevice

FDA's official blog brought to you from FDA's senior leadership and staff stationed at home and abroad - sharing news, background, announcements and other information about the work done at the FDA on behalf of the American public.

Margaret Hamburg

By: Margaret A. Hamburg, M.D.

It has been 11 years since Congress passed the Best Pharmaceuticals for Children Act mandating the creation of the Office of Pediatric Therapeutics (OPT) at FDA.  But it has been light years in terms of the progress we have made to ensure that children have access to innovative, safe and effective medical products.

FDA approves Biotronik's "smaller, thinner" heart rhythm implants

May 7, 2013 by Arezu Sarvestani

Biotronik wins FDA approval for its next-generation Ilesto 7 suite of implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators.

Biotronik logo

German medical device maker Biotronik today touted FDA approval for its Ilesto 7 line of next-generation implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators.

The devices are smaller, thinner and lighter and the new Ilesto DX allows physicians to monitor atrial information and possibly diagnose previously undetected instance of atrial fibrillation.

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FDA's collaboration with Chinese partners gets stronger each year

May 7, 2013 by MassDevice

FDA's official blog brought to you from FDA's senior leadership and staff stationed at home and abroad - sharing news, background, announcements and other information about the work done at the FDA on behalf of the American public.

Mary Lou Valdez, FDA’s Associate Commissioner for International Programs

By: Mary Lou Valdez

"What's in a name?" Shakespeare famously asked. "A rose," his Juliet reasoned, "by any other name would smell as sweet." And often, we know, that's true.  But other times, a change in name can signify some larger, more substantive shift.

The latter was the case in mid-April when we sat down in Washington to meet with one of China's key regulatory agencies, the China Food and Drug Administration (CFDA). 

J&J's Ethicon Endo-Surgery wins FDA approval for Sedasys computer-assisted anesthesia device

May 6, 2013 by Sony Salzman

Johnson & Johnson's Ethicon Endo-Surgery division finally wins pre-market approval from the FDA for its Sedasys computer-assisted anesthesia device.

Johnson & Johnson's (NYSE:JNJ) Ethicon Endo-Surgery division landed a hard-won pre-market approval from the FDA for its Sedasys computer-assisted personalized sedation system.

The PMA follows a back-and-forth with the federal watchdog agency over the device that dates back to the initial PMA submission for the Sedasys system in 2008. Ethicon Endo-Surgery got another shot with the FDA after its original PMA bid was denied.

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SpinalMotion wins FDA panel review date for metal-on-metal artificial disc

May 6, 2013 by Arezu Sarvestani

SpinalMotion wins an FDA panel date to review a premarket approval application for the Kineflex/C metal-on-metal artificial disc replacement system.

SpinalMotion Logo

 Mountain View, Calif.-based medical device maker SpinalMotion will get its date with the FDA this summer, when a panel of experts will consider and make recommendations on the company's Kineflex/C artificial disc.

On July 24, 2013, the FDA's orthopedic & rehabilitation devices panel will review information on the Kineflex/C and made a recommendation on whether the federal watchdog agency should approve the device for the U.S. market.

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