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YOLO Medical Inc. Announces YOLO Curve Receives Health Canada Approval

February 2, 2012 5:25 am | News | Comments

VANCOUVER, British Columbia--(BUSINESS WIRE)--YOLO Medical Inc. announced today that its newest laser device, the YOLO Curve, has received Health Canada Approval. The YOLO Curve is a non-invasive, non-thermal, low-level, red laser intended for use in body contouring...

TearScience Achieves FDA Clearance for Second Generation LipiFlow Thermal Pulsation System

February 2, 2012 5:22 am | News | Comments

MORRISVILLE, N.C.--(BUSINESS WIRE)--TearScience, Inc., a privately-held medical device company, today announced that it has received U.S. Food and Drug Administration (FDA) clearance for its next generation product of its LipiFlow® Thermal Pulsation System, a medical device...

Haldor Advanced Technologies Commercially Introduces the New ORLocate Surgical Instrument Tracking System to North America

February 2, 2012 5:15 am | News | Comments

TEL AVIV, Israel & BOSTON--(BUSINESS WIRE)--Haldor Advanced Technologies announced today the commercial launch in North America of its ORLocateâ„¢ surgical instrument tracking and asset management system. ORLocateâ„¢ is the first commercially available system that uses...

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Medtronic Announces First Patient Enrollment in Clinical Trial Assessing Guideline-Based Heart Failure Management in Primary Care Setting

February 2, 2012 5:12 am | News | Comments

MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. today announced the initiation and first patient enrollment in a clinical study that will evaluate gaps in the implementation of evidence-based treatment guidelines among chronic heart failure patients post-hospital discharge.

NLT SPINE Receives 510(k) Clearance for Its Lumbar Interbody Fusion Device, PROW FUSION

February 2, 2012 5:10 am | News | Comments

KFAR SABA, Israel--(BUSINESS WIRE)--NLT SPINE, a developer of Minimally Invasive Spine Surgery (MISS) products, today announced that its PROW FUSIONâ„¢ device received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

Horizon Medical Services, Ltd. Receives Health Canada Approval on Hitachi SCENARIA 64-Slice CT

February 2, 2012 5:07 am | News | Comments

CLEVELAND--(BUSINESS WIRE)--Hitachi Medical Systems America (HMSA) and Horizon Medical Services are pleased to announce that they have received Health Canada approval for the SCENARIA 64-slice CT System. SCENARIA offers the latest dose saving technologies...

Health Discovery Corporation Launches Android Version of Popular MelApp, Melanoma Risk Analysis Mobile Phone App

February 2, 2012 5:00 am | News | Comments

SAVANNAH, Ga.--(BUSINESS WIRE)--Health Discovery Corporation, the molecular diagnostics company that launched MelApp, the first SVM-based image analysis iPhone app for melanoma risk assessment, today debuts its popular MelApp mobile app for Androidâ„¢ devices.

Solvay's Radel PPSU Replaces Acetal in Quick Coupling for Surgical Sterilization Unit

February 2, 2012 4:51 am | News | Comments

ALPHARETTA, Ga. – LinkTech Quick Couplings, a leading global supplier of quick couplings and valves based in Ventura, Calif., has expanded its product line, offering a new quick coupling made of Radel® polyphenylsulfone (PPSU) resin from Solvay Specialty Polymers USA, LLC...

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Emory University Study Reveals Silicone Breast Implant Device Significantly Reduces Contamination

February 2, 2012 4:46 am | News | Comments

STUART, Fla./PRNewswire/ -- Today, the Aesthetic Surgery Journal published an article by Emory University researchers on an FDA Class 1 device used in the delivery of silicone gel implants. Researchers found the Keller Funnel™ developed by Stuart, Florida based Keller Medical Inc...

Extended Sunshine Act Deadline Provides Extra Time for Pharma, Biotech and Device Companies to Track and Report Physician Payments

February 1, 2012 5:56 am | News | Comments

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--As the industry awaits the release of the delayed Sunshine Act guidelines, pharmaceutical and medical device companies are benefiting from the extra time by reviewing current physician payment reporting structures...

Valley Presbyterian Hospital Site for First Use of New Heart Device in U.S. since FDA Approval

February 1, 2012 5:51 am | News | Comments

VAN NUYS, Calif.--(BUSINESS WIRE)--Valley Presbyterian Hospital (VPH) was the site for the first implantation in the U.S. of a new heart device since the Food and Drug Administration (FDA) approved the DF4 High-Voltage Connector System by Medtronic earlier this month...

Sorin Group Launches a New Complete Portfolio of Pacing, Defibrillation and Left Ventricular Leads

February 1, 2012 5:48 am | News | Comments

MILAN--(BUSINESS WIRE)--Sorin Group, a global medical company and a leader in the treatment of cardiovascular diseases, announced CE Mark approval and commercial launch for a comprehensive new range of pacing, defibrillation and left ventricular leads. Designed for safety...

nanoMAG LLC Wins New NSF Funding For Development of Bioabsorbable Orthopaedic Implants Made of High-Strength Magnesium Alloys

February 1, 2012 5:42 am | News | Comments

LIVONIA, Mich. – nanoMAG LLC, Livonia, Mich., the developer of novel lightweight, high-strength magnesium alloy technology, has been awarded new funding from the National Science Foundation (NSF) for further research and application development of its unique material. A contract extension...

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US Demand for Drug Delivery Products to Reach $134 Billion in 2015

February 1, 2012 5:34 am | News | Comments

US demand for drug delivery products will expand 7.4 percent annually to $134 billion in 2015. The best growth opportunities will emerge in dosage formulations that advance the nature of therapy for autoimmune conditions, cancer, heart disease, neurological disorders...

DSM ComfortCoat hydrophilic coating enhances the capabilities of EPflex medical guidewires

February 1, 2012 5:31 am | News | Comments

DSM, a global leader in biomedical materials sciences, today announced a successful collaboration with medical manufacturer EPflex to launch a new set of guidewires with ComfortCoat® hydrophilic coating, a proprietary DSM technology. EPflex will manufacture...

Cook Medical Launches Zenith Low Profile Endovascular Graft in Canada

February 1, 2012 5:28 am | News | Comments

Stouffville, Ontario-Following Health Canada approval, the Zenith Low Profile AAA Endovascular Graft (Zenith AAA LP) from Cook Medical is now approved and will be launched to physicians in Canada. With a low-profile delivery system diameter of 18 Fr and simplified deployment...

Space researchers develop ultrasound technology that detects, treats kidney stones

February 1, 2012 5:25 am | News | Comments

HOUSTON – Just the mention of kidney stones can cause a person to cringe. They are often painful and sometimes difficult to remove, and 10 percent of the population will suffer from them. In space, the risk of developing kidney stones is exacerbated due to environmental conditions.

Singapore Scientists Lead in 3D Mapping of Human Genome to Help Understand Human Diseases

February 1, 2012 5:20 am | News | Comments

Singapore - (ACN Newswire) - Genome Institute of Singapore's (GIS) Associate Director of Genomic Technologies, Dr Yijun RUAN, led a continuing study on the human genome spatial/structural configuration, revealing how genes interact/communicate and influence each other, even when...

Roche Receives FDA Clearance for Test to Screen and Diagnose Chlamydia and Gonorrhea Infection in Symptomatic and Asymptomatic Patients

February 1, 2012 5:15 am | News | Comments

PLEASANTON, Calif./PRNewswire/ -- Roche announced today that the U.S. Food and Drug Administration (FDA) has provided 510(k) clearance to the cobas® CT/NG Test for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections in both symptomatic...

FDA and industry reach agreement in principle on medical device user fees

February 1, 2012 5:12 am | News | Comments

The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees...

Lo/Ovral-28 (Norgestrel/EthinylEstradiol) Tablets: Recall - Possibility of Inexact Tablet Counts or Out of Sequence Tablets

February 1, 2012 4:30 am | by U.S. Food & Drug Administration | News | Comments

Oral contraceptive daily regimen may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.

Vitaflo USA Renastart: Recall - Possible Health Risk Due To Incorrectly Labeled Cans

January 31, 2012 8:30 am | by U.S. Food & Drug Administration | News | Comments

Consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia).

Fourth German Hospital Selects IntraOp Medical Corporation's Mobetron

January 31, 2012 6:04 am | News | Comments

SUNNYVALE, Calif.--(BUSINESS WIRE)--IntraOp Medical Corporation today announced that Helios Berlin Buch became the fourth German hospital and the nineteenth European hospital to purchase a Mobetron for Intra-Operative Electron Radiation Therapy (IOERT).

Covidien Revascularization Device Approved for Interventional Management of Stroke Trial

January 31, 2012 6:01 am | News | Comments

MANSFIELD, Mass.--(BUSINESS WIRE)--Covidien, a leading global provider of healthcare products, today announced that the Solitaireâ„¢ FR Revascularization Device has been approved for investigational use in the Interventional Management of Stroke (IMS III) trial. The Solitaire FR...

Medtronic Announces FDA Approval of DF4 High-Voltage Connector System for Implantable Cardioverter Defibrillator and Cardiac Resynchronization Therapy Devices

January 31, 2012 5:59 am | News | Comments

MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. today announced the U.S. Food and Drug Administration (FDA) approval and launch of the DF4 High-Voltage Connector System, a right ventricular lead and connector used with implantable cardioverter defibrillators (ICDs) and cardiac...

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