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X-spine Announces FDA Clearance of Novel Calix-PC Spinal Implant System

November 16, 2011 5:08 am | News | Comments

MIAMISBURG, Ohio--(BUSINESS WIRE)--X-spine, a global manufacturer of devices for the treatment of spinal disease, today announced FDA clearance of the Calix PCâ„¢ Spinal Implant System to join its growing portfolio of innovative spinal devices. The Calix PC is an intervertebral body fusion system...

Welch Allyn Introduces High-Performance Healthcare Technology at Medica 2011

November 16, 2011 4:56 am | News | Comments

Medica International Trade Fair and Congress, Düsseldorf, Germany, November 16, 2011-Welch Allyn, a leading global provider of medical diagnostic devices headquartered in Skaneateles Falls, NY, unveiled its newest generation of connected solutions designed to address the needs of busy medical practices...

BIOTRONIK Announces Six-Month Coronary Stenting ENERGY Registry Results Presented at TCT 2011

November 15, 2011 5:59 am | News | Comments

BUELACH, Switzerland--(BUSINESS WIRE)--BIOTRONIK AG announced that the six-month results of the ENERGY Registry were presented last week by Prof. Raimund Erbel at the Transcatheter Cardiovascular Therapeutics (TCT 2011) conference. This all-comers registry is investigating...

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Toshiba's Cardiovascular Systems Make Transradial Approach Easier and Safer

November 15, 2011 5:56 am | News | Comments

TUSTIN, Calif.--(BUSINESS WIRE)--Performing cardiac catheterizations through the radial artery is proven to make exams safer for patients while frequently reducing post-procedure hospital stay times. To conduct radial interventions from both the right and left side, Harrison Medical Center in Bremerton, Wash...

BioVentrix Completes Enrollment in Pilot Human Clinical Trial of the PliCath HFâ„¢ Heart Failure Treatment System

November 15, 2011 5:39 am | News | Comments

SAN RAMON, Calif.--(BUSINESS WIRE)--BioVentrix, developer of the PliCath HF™ System, today announced the achievement of a significant milestone – completion of enrollment in its pilot human clinical trial. PliCath HF is a novel device which enables Epicardial Catheter-based Ventricular Restoration (ECVR).

MedPro Safety Products Receives ISO 13485 Recertification

November 15, 2011 5:35 am | News | Comments

LEXINGTON, Ky.--(BUSINESS WIRE)--MedPro Safety Products, Inc. (OTCBB: MPSP), a leading developer of transformational technologies that enable safer medication delivery and blood collection, today announced that it has passed its ISO 13485 recertification audit.

ZOLL LifeVest Wearable Defibrillator Highly Cost-Effective Therapy

November 15, 2011 5:32 am | News | Comments

CHELMSFORD, Mass.--(BUSINESS WIRE)--ZOLL Medical Corporation (NASDAQ GS: ZOLL), a manufacturer of medical devices and related software solutions, announced today that data showing the cost-effectiveness of the LifeVest® Wearable Defibrillator was presented...

Torax Medical Receives CE Mark for the FENIX Continence Restoration System

November 15, 2011 5:22 am | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--Torax® Medical Inc. has received CE Mark for its FENIX™ Continence Restoration System, an innovative new approach to the treatment of fecal incontinence. Fecal Incontinence (FI) is the inability to control bowel movements.

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Presbia Announces 12-Month Results for Flexivue Microlens

November 15, 2011 5:19 am | News | Comments

AMSTERDAM--(BUSINESS WIRE)--Presbia, a medical device company and leader in near vision restoration, announced today its preliminary 12-month post market surveillance study of patients implanted with the Flexivue Microlens®, a corneal inlay treatment for presbyopia.

DSM ComfortCoat® Hydrophilic Coating Utilized in New Drug Eluting Stent Delivery System from CID SpA

November 15, 2011 5:06 am | News | Comments

BERKELEY, Calif.--(BUSINESS WIRE)--DSM, a global leader in biomedical materials science, today announced the use of its ComfortCoat® hydrophilic coating on the delivery system of CID SpA's new Cre8™ Drug Eluting Stent (DES), CE marked the 16th of July 2011.

Positive Clinical Study Results for BSP's HyperQ Technology will be reported in American Journal of Cardiology

November 15, 2011 4:56 am | News | Comments

Tel - Aviv, November 14, 2011 - BSP Biological Signal Processing Ltd. (BSP) (TASE: BSP), which develops and manufactures products for the non-invasive, accurate diagnosis of Coronary Artery Disease (CAD), recently announced the successful completion of a comprehensive clinical research study...

Over 100,000 People Urge the FDA to Issue Clear and Reasonable Guidance on the Artificial Pancreas

November 15, 2011 4:52 am | News | Comments

Washington, D.C. – Over 100,000 people throughout the country have signed a petition urging the FDA to issue clear and reasonable guidance  for development of an artificial pancreas (AP), the most revolutionary advance in treating type 1 diabetes (T1D) since the discovery of insulin.

Leadless pacemaker brings new hope to cardiac patients

November 15, 2011 4:50 am | News | Comments

Cambridge, MA and UK– November 14, 2011 – Cambridge Consultants, a leading technology design and development firm, today unveiled how it has collaborated with start-up company EBR Systems to develop the world's first wireless pacing system. With cardiac stimulation leads...

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Virility Max: Recall - Undeclared Drug Ingredient

November 14, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

Product marketed as dietary supplement contains sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.

North Carolina Medicaid Issues Favorable Policy on ZOLL LifeVest Wearable Defibrillator

November 14, 2011 5:45 am | News | Comments

CHELMSFORD, Mass.--(BUSINESS WIRE)--ZOLL Medical Corporation (NASDAQ GS: ZOLL), the manufacturer of the LifeVest® Wearable Defibrillator, announced today that North Carolina's Division of Medical Assistance has established a coverage policy for wearable cardioverter defibrillators.

Spacelabs Healthcare to Unveil New Technologies at MEDICA 2011

November 14, 2011 5:38 am | News | Comments

ISSAQUAH, Wash.--(BUSINESS WIRE)--Spacelabs Healthcare, an international developer, manufacturer and distributor of medical equipment and services will have a major presence in Düsseldorf next week at MEDICA 2011, as the company unveils a wide array of new technologies at the world's largest healthcare trade fair.

New Data Confirms Early Implantation of Impella 2.5 Prior to PCI Improves Survival in Shock Patients

November 14, 2011 5:31 am | News | Comments

DANVERS, Mass. & SAN FRANCISCO--(BUSINESS WIRE)--Abiomed Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today announced new results from a multicenter retrospective study demonstrating that early initiation of support with Impella® 2.5...

Neovasc Inc. Receives CE Mark for Reducer Product to Treat Refractory Angina

November 14, 2011 5:17 am | News | Comments

November 14, 2011 - Vancouver, BC, Canada - Neovasc Inc. (TSXV: NVC), today announced that it has received the CE mark designation for its Reducerâ„¢ product for the treatment of refractory angina. CE marking confirms that the Reducer conforms to the applicable European Directive...

New WilloMD Pain Management Technology Holds Great Promise in Light of New Stanford Discovery Relating to the Cause of Osteoarthritis

November 14, 2011 5:13 am | News | Comments

MONROE, Mich., Nov. 14, 2011 /PRNewswire/ -- Physician's Technology, LLC welcomes and supports information released yesterday relating to the discovery of a new cause of osteoarthritis. Findings by senior investigator Dr. William Robinson at Stanford are reported in the journal Nature Medicine.

The future of skin cancer diagnosis is connected

November 14, 2011 5:11 am | News | Comments

At Medica fair 2011 in Germany, FotoFinder presents the future of early skin cancer detection. In the center of attention is the fast diagnostic exchange between doctors using mobile communication technology. With handyscope for iPhone and the corresponding App, FotoFinder...

Australian medical technologies to scope the European market

November 14, 2011 4:46 am | News | Comments

A wearable, discreet cardiovascular vital signs monitor developed at the University of Technology, Sydney (UTS) and a portable device for diagnosing the severity of whiplash from The University of Queensland (UQ) are among more than 25 cutting edge medical innovations that leading university research commercialisation...

FDA Issues Two Guidances to Boost First-In-Human Studies

November 11, 2011 2:31 pm | by U.S. Food & Drug Administration | News | Comments

The FDA proposes to streamline device clinical trials in a pair of draft guidances outlining requirements for early feasibility studies and explaining when a trial can begin even when there are outstanding issues with an Investigational Device Exemption (IDE) submission.

FDA, Devicemakers Want to Accelerate User Fee Talks, But Disagreement Reigns

November 11, 2011 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Medical device industry reps and FDA officials negotiating the next user fee authorization are behind schedule and want to accelerate their progress, but those meetings remain acrimonious and the parties are still far apart on major issues.

Securing Success for Orthopedic Implants

November 11, 2011 10:11 am | by Del Williams | Articles | Comments

The Challenge: A company needed a fastener for an orthopedic device that would offer a high degree of repeatability in motion without a loss of function. The Solution: The Spiralock self locking fastener successfully survived load and fatigue testing to one-million cycles without loosening or backing out.

InSeal Medical Announces Patients Successfully Treated with Novel Intravascular Large Bore Puncture Closure Device

November 11, 2011 4:59 am | News | Comments

SAN FRANCISCO & CAESAREA, Israel--(BUSINESS WIRE)--InSeal Medical Ltd., developer of percutaneous vascular closure devices for large bore punctures, today announced the successful treatment of three patients with its investigational intravascular large bore puncture closure device.

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