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Regulators Probe J&J's Marketing of Recalled Hip Implants

February 25, 2013 12:04 pm | by Mass Device | News | Comments

Federal investigators recently launched an additional inquiry into Johnson & Johnson and its DePuy Orthopaedics subsidiary, taking a closer look at marketing practices surrounding a line of recalled metal-on-metal hips. J&J confirmed in regulatory filings last week that the U.S. State Attorney's Office for the District of Massachusetts and the Civil Division of the U.S. Justice Dept...

Saint Luke's Mid America Heart Institute Clinical Trial To Investigate Effectiveness Of Cardiac Surgery Device

February 25, 2013 11:45 am | by PR Newswire | News | Comments

Clinical trial to determine if chest closure device leads to better bone healing following cardiac surgery KANSAS CITY, Mo., Feb. 25, 2013 /PRNewswire-USNewswire/ -- Patients undergoing open heart procedures such as coronary artery bypass or valve surgery may be...

CSI Presents Three-Year Orbit I Coronary Data at CRT 2013

February 25, 2013 11:00 am | by The Associated Press | News | Comments

ST. PAUL, Minn. & WASHINGTON--(BUSINESS WIRE)--Feb 25, 2013--Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), today presented three-year data from its ORBIT I feasibility study of calcified coronary lesions during a poster session at the 2013 Cardiovascular Research Technologies (CRT)...


FDA Approves Longer Lengths of Medtronic's Resolute Integrity Stent

February 25, 2013 9:06 am | by The Associated Press | News | Comments

Expanding the applicability of its marquee product for the interventional treatment of coronary artery disease in the United States, Medtronic, Inc. announced today that the FDA has approved the 34 mm and 38 mm lengths of the Resolute Integrity drug-eluting stent in diameters of 3.0mm, 3.5mm, and 4.0mm with an indication for patients with diabetes.

FDA Approves First Single-Lead ICD with Atrial Sensing

February 25, 2013 9:00 am | by The Associated Press | News | Comments

LAKE OSWEGO, Ore.--(BUSINESS WIRE)--Feb 25, 2013--BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced the Food and Drug Administration (FDA) has granted final approval for the BIOTRONIK Lumax 740 DX System. This novel device is a first-in-class implantable cardiac...

University of Michigan's Zell Lurie Institute Awards $112,000 to Promising Student Startups in 30th Annual Business Plan Competition and Dare to Dream Grant Program

February 25, 2013 9:00 am | by PR Newswire | News | Comments

Best Business Focus Receives $20,000 for Physical Therapy Device and Application ANN ARBOR, Mich., Feb. 25, 2013 /PRNewswire-USNewswire/ -- The Samuel Zell & Robert H. Lurie Institute for Entrepreneurial Studies at the University of Michigan's Stephen M. Ross School of...

LabCorp Launches Next Generation Sequencing Assay for Familial Cardiac Disease

February 25, 2013 8:45 am | by The Associated Press | News | Comments

BURLINGTON, N.C.--(BUSINESS WIRE)--Feb 25, 2013--Laboratory Corporation of America ® Holdings (LabCorp ® ) (NYSE: LH) today announced it has launched its clinical next generation sequencing assay, GeneSeq®: Cardio for genetic causes of familial cardiac disease. Familial cardiac diseases are...

CardioDx to Present at Cowen and Company 33rd Annual Healthcare Conference

February 25, 2013 8:30 am | by The Associated Press | News | Comments

CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced that the company will present at the Cowen and Company 33rd Annual Healthcare Conference on Monday, March 4, 2013 at 10:00 a.m. ET at the Boston Marriott Copley Place in Boston.


Atossa Genetics Receives Warning Letter From the Food and Drug Administration

February 25, 2013 8:30 am | by The Associated Press | News | Comments

SEATTLE--(BUSINESS WIRE)--Feb 25, 2013--Atossa Genetics, Inc. (NASDAQ: ATOS) (“Atossa” or the “Company”) received a Warning Letter (“Letter”) from the FDA on February 21, 2013, regarding its Mammary Aspirate Specimen Cytology Test (MASCT) System and MASCT System Collection Test (together, the...

MetroStar Home Health COO Asks Congress to Cease Round 2 of The Centers for Medicare Services' Medical Equipment Bidding Process

February 25, 2013 8:30 am | by PR Newswire | News | Comments

NEW YORK, Feb. 25, 2013 /PRNewswire/ -- Durable Medical Equipment companies across their country join in the effort to protect Medicare Beneficiaries from devastating changes as a result of new Medicare suggested by The Centers for Medicare & Medicaid Services (CMS).

Ocular Therapeutix Completes PMA Submission for ReSure® Sealant

February 25, 2013 8:00 am | by The Associated Press | News | Comments

BEDFORD, Mass.--(BUSINESS WIRE)--Feb 25, 2013--Ocular Therapeutix, Inc. announced today that it has submitted its Premarket Approval (PMA) Application to the U.S. Food and Drug Administration (FDA) for ReSure Sealant, a novel ophthalmic medical device that utilizes the company’s proprietary...

Implanted Electrodes Can Help Amputees Gain Sensation in Prosthetics

February 25, 2013 7:29 am | by Mass Device | News | Comments

Swiss researchers have a developed a new prosthetic limb system that uses implanted electrodes to send sensory signals from the limb back to the brain, creating a more realistic sense of touch. "We could be on the cusp of providing new and more effective clinical solutions to amputees in the next years," Silvestro Micera, head engineer...

Syneron Settles Patent Lawsuit Against EndyMed

February 25, 2013 5:00 am | by Mass Device | News | Comments

Syneron Medical dropped a patent infringement lawsuit against EndyMed Medical and its distributor, Eclipse Aesthetics, after EndyMed agreed to stop selling its fractional skin resurfacing products in the U.S. EndyMed will continue to re-supply electrodes and other maintenance items for the products it has already sold, according to a press release.


Class I Medical Device Recall: Lumenis Limited, Lumenis VersaCut Tissue Morcellator

February 25, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Lumenis Limited is recalling certain models of VersaCut Morcellator devices to correct its labeling. There is a potential for air embolisms to occur if the aspiration tubing is hooked up backwards to the aspiration control box housing. This product may cause serious adverse health consequences, including death.

FDA Hits Depuy with Class 1 Recall over Joint Sleeve

February 24, 2013 8:35 pm | by Mass Device | News | Comments

Johnson & Johnson subsidiary DePuy Orthopaedics is in hot water again, this time due to a limb preservation system sleeve that's being pulled out of surgery suites in a recall rated Class 1 by the FDA. The diaphyseal sleeve is used to reconnect tissues during joint surgery.

FDA Panel Recommends Approval of Neuropace's Anti-Epilepsy Implant

February 22, 2013 6:33 pm | by Mass Device | News | Comments

California neurostimulation devices maker NeuroPace crept 1 step closer to an FDA win for its epilepsy implant with near-unanimous approval from the FDA's Neurological Devices Advisory Panel. The expert panelists today voted unanimously that the RNS implantable neurostimulator demonstrated safety in clinical trials...

AACR Congratulates Recipients of the Inaugural Breakthrough Prize in Life Sciences

February 22, 2013 1:30 pm | by AACR | News | Comments

AACR President-elect Charles L. Sawyers, M.D. is among the 11 winners.   PHILADELPHIA — The American Association for Cancer Research congratulates the recipients of the first Breakthrough Prize in Life Sciences. Nine of the 11 recipients are members of the AACR, including President-elect Charles L. Sawyers, M.D.

FDA OKs Wellaho Mobile Patient Health Monitoring System

February 22, 2013 11:29 am | by Mass Device | News | Comments

California mobile health services company Sanitas won FDA clearance for its Wellaho system, a proprietary mobile and online platform providing a link between patients and healthcare providers. The Wellaho platform is "an outpatient management system for chronically ill patients," according to the company's website.

Orthofix Q4 earnings boom but sales lag on challenges overseas

February 22, 2013 10:29 am | by Mass Device | News | Comments

Orthopedic devices maker Orthofix makes big strides in its profit margin expansion program, but suffers setbacks in sales due to obstacles in international markets. Medical device maker Orthofix (NSDQ:OFIX) posted huge growth for its bottom line in both the 4th quarter and full year of 2012, but reported sliding sales and projected slow growth for the year ahead.

Imalux Corporation Engages Advisor to Explore Strategic Options

February 22, 2013 9:54 am | by Bio-Medicine.Org | News | Comments

NAPLES, Fla. , Feb. 22, 2013 /- Falls River Group LLC announces they have been engaged by Imalux Corporation, manufacturer of the FDA cleared, Niris 1300e imaging system, to pursue strategic relationships for the company in order to increase the widespread use of the system. A newly developed application...

Biotronik Lands Euro Approval for MRI-Friendly Heart Implants

February 22, 2013 9:29 am | by Mass Device | News | Comments

German medical device maker Biotronik won European regulatory approval for its Ilesto 7 line of MRI-friendly heart implants. The Ilesto 7 line includes cardiac resynchronization therapy defibrillator and one of the world's smallest implantable cardioverter-defibrillators, according to Biotronik.

Lab21 and IntegraGen Partner to Develop New Colorectal Cancer Diagnostic

February 22, 2013 5:09 am | by The Associated Press | News | Comments

CAMBRIDGE, England--(BUSINESS WIRE)--Feb 22, 2013--Lab21 Limited, the global specialist in personalised medicine and clinical diagnostics, has entered into an agreement with IntegraGen, a leading player in the development and marketing of molecular diagnostic testing in autism and oncology, to...

Blaze Bioscience Announces Completion of Series A Financing - Brings Total Investment to $9.8 Million

February 22, 2013 5:00 am | by The Associated Press | News | Comments

SEATTLE--(BUSINESS WIRE)--Feb 22, 2013--Blaze Bioscience, Inc., a biotechnology company dedicated to developing innovative products to improve the lives of cancer patients, today announced the completion of a Series A financing totaling $8.5 million and bringing the total funds raised since...

Panagene Signs Off with Dako to Supply PNA Oligomer Component

February 22, 2013 3:01 am | by The Associated Press | News | Comments

DAEJEON, South Korea--(BUSINESS WIRE)--Feb 22, 2013--Panagene announced it has signed a supply agreement with Dako Denmark A/S to supply PNA oligomer key component for incorporation into Dako’s diagnostic or research products. Dako, an Agilent Technologies Company since June 2012, is a leading...

Class I Medical Device Recall: DePuy Orthopaedics, Inc. - LPS Diaphyseal Sleeve

February 22, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. This may result in fracture of...

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