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510(k)

FDA approves expanded use for Abbott’s carotid stent | Regulatory roundup

May 6, 2011 By MassDevice staff Leave a Comment

ABT, FDA logos

Abbott Laboratories (NYSE:ABT) won aproval from the FDA for expanded use of its RX Acculink carotid stent system.

The expanded indication means the stent system can be used to treat carotid artery disease patients who have a standard risk for complications from carotid endarterectomy surgery, a procedure that entails cutting open a patient’s neck artery and scraping out blockages.

Filed Under: 510(k), News Well, Pre-Market Approval (PMA) Tagged With: Abbott, Novartis, Solta Medical Inc., Sorin Group, Xlumena

FDA releases April 2011 510(k) clearances

May 5, 2011 By MassDevice staff Leave a Comment

FDA logo

April 2011 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL

DECISIONS RENDERED DURING THE PERIOD April 2011

DEVICE: VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM

C.R. BARD, INC. 510(k) NO: K110820(SPECIAL)

ATTN: KETI SINO PHONE NO : 401 825 8575

100 CROSSINGS BOULEVARD SE DECISION MADE: 01-APR-11

WARWICK RI 02886 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSSEOTITE II MODEL XIFOSSXXX

BIOMET 3I, INC. 510(k) NO: K100724(TRADITIONAL)

Filed Under: 510(k), Food & Drug Administration (FDA), News Well

FDA releases March 2011 510(k) clearances

May 5, 2011 By MassDevice staff Leave a Comment

FDA logo

March 2011 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL

DECISIONS RENDERED DURING THE PERIOD March 2011

DEVICE: TROKAMED MORCELLATOR AND SHAVER

TROKAMED GMBH 510(k) NO: K091010(TRADITIONAL)

ATTN: ANGELIKA SCHERP PHONE NO : 31 206 125626

AMSTEL 320-I SE DECISION MADE: 01-MAR-11

AMSTERDAM NL 1017AP 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANDOX ECSTASY (MDMA) ASSAY

Filed Under: 510(k), Food & Drug Administration (FDA)

Boston Scientific, Medtronic extend atrial fibrillation treatment offerings with new approvals

May 3, 2011 By MassDevice staff Leave a Comment

Medtronic

Boston Scientific Corp. (NYSE:BSX) and Medtronic Inc. (NYSE:MDT) both announced regulatory approvals for new products that will expand their atrial fibrillation treatment offerings.

Natick, Mass.-based Boston Scientific won CE Mark approval for its Blazer open-irrigated, a radiofrequency ablation (RFA) catheter for treating atrial fibrillation and other arrhythmias.

Filed Under: 510(k), News Well, Pre-Market Approval (PMA) Tagged With: Boston Scientific, Femasys Inc., Idaho Technology Inc., Kelyniam Global Inc.

FDA approves low testosterone gel from Abbott | Regulatory roundup

April 30, 2011 By MassDevice staff Leave a Comment

Clearances roundup

Abbott Laboratories (NYSE:ABT) landed FDA approval for a new testosterone-boosting product.

The company’s AndroGel 1.62% is treatment for male low testosterone levels, also know as hypogonadism, which affects nearly 14 million men in the United States, according to the company.

Filed Under: 510(k), News Well Tagged With: Abbott, IDEV Technologies Inc., Maquet Cardiovascular LLC, Quest Diagnostics Inc., STAAR Surgical Co

FDA clears Biomet’s hip implant | Regulatory roundup

April 27, 2011 By MassDevice staff Leave a Comment

Clearances roundup

Biomet Inc. received FDA 510(k) clearance for its new hip replacement device.

Warsaw, Ind.-based company said its Active Articulation E1 dual mobility hip system is an implant option for orthopedic surgeons performing hip replacement surgery.

Filed Under: 510(k), News Well, Pre-Market Approval (PMA) Tagged With: Biomet, Biotronik, Guided Therapeutics Inc., MedShape Solutions Inc., Reverse Medical Corp., SiBone, Varian Medical Systems, VeraLight Inc.

InfraReDx wins CE Mark approval for coronary imaging system | Regulatory roundup

April 21, 2011 By MassDevice staff Leave a Comment

InfraReDx

InfraReDx Inc. added the European Union to its market for the LipiScan IVUS coronary imaging system.

The Burlington, Mass.-based company won CE Mark approval for the device, which employs both so-called "near-infrared" (NIR) spectroscopy and intravascular ultrasound (IVUS) technology to give cardiologists a grayscale image of a coronary artery, along with a map of lipid core coronary plaques within a blood vessel.

Filed Under: 510(k), Food & Drug Administration (FDA), News Well Tagged With: Biomerix Corp., Hologic, InfraReDx Inc., Orthocon Inc.

FDA 510(k) clearances too slack: GAO

April 15, 2011 By MassDevice staff Leave a Comment

MASSDEVICE ON CALL — FDA 510(k) clearances too slack: GAO. The Government Accountability Office claims that the FDA is putting patients at risk by clearing medical devices such as hip replacements and heart defibrillators under the same system the agency uses to approve power wheelchairs, stitches and catheters, reports The Associated Press.

Filed Under: 510(k), Food & Drug Administration (FDA), Healthcare Reform, News Well Tagged With: Athenahealth Inc.

FDA approves spine sealant from Covidien | Regulatory roundup

April 15, 2011 By MassDevice staff Leave a Comment

Clearances roundup

Here’s a roundup of companies announcing clearances and approvals from the FDA and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.

Filed Under: 510(k), News Well, Pre-Market Approval (PMA) Tagged With: Aethlon Medical Inc., Cepheid, Covidien, Delcath Systems Inc., GE Healthcare, Integra LifeSciences, stjudemedical, ThermoGenesis Corp., XDx Inc.

SPR Therapeutics preps for pain device launch, pending FDA clearance

April 12, 2011 By MedCity News Leave a Comment

SPR Therapeutics

Assuming all goes well in a federal regulatory review, neurotechnology startup SPR Therapeutics LLC expects to begin commercializing its first product, a pain relief device, by the end of the year.

Year-old SPR (it stands for “stimulation for pain relief”) is one of the newest members of the Cleveland area’s growing cluster of neurotechnology firms.

Filed Under: 510(k), News Well, Pain Management Tagged With: NDI Medical, SPR Therapeutics LLC

FDA approves Covidien brain aneurysm treatment | Regulatory roundup

April 6, 2011 By MassDevice staff Leave a Comment

Clearances roundup

The FDA granted Covidien plc (NYSE:COV) pre-market approval for its brain aneurysm treatment device.

The Mansfield, Mass.-based company designed its new endovascular device, aptly called the Pipeline, to redirect blood flow away from an aneurysm so an embolization can be performed.

Filed Under: 510(k), News Well, Pre-Market Approval (PMA) Tagged With: Alere, Alphatec, Covidien, CryoLife, Hospira Inc., IRIS International Inc., Philips, Reverse Medical Corp., Spectranetics Corp.

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