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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.

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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.

BIOTRONIK Announces Positive Results for Pantera Lux Paclitaxel Releasing Balloon

November 11, 2011 4:57 am | News | Comments

SAN FRANCISCO--(BUSINESS WIRE)--Six-month results from the DELUX registry and 12-month results from the PEPPER study, both demonstrating excellent safety and efficacy results for the Pantera Lux Paclitaxel Releasing Balloon, were presented on Tuesday and Wednesday...

U-Systems' Automated Breast Ultrasound Premarket Approval Application for Breast Cancer Screening Accepted for FDA Review

November 11, 2011 4:53 am | News | Comments

SUNNYVALE, Calif.--(BUSINESS WIRE)--U-Systems, the leader in automated breast ultrasound, today announced that the U.S. Food & Drug Administration (FDA) has determined the premarket approval (PMA) application, for breast cancer screening indication for use for the somo•v® Automated Breast Ultrasound (ABUS) system...

Fresenius Medical Care introduces 2008K@homeâ„¢ hemodialysis delivery system in North America

November 11, 2011 4:50 am | News | Comments

BAD HOMBURG, Germany--(BUSINESS WIRE)--Fresenius Medical Care AG & Co. KGaA (“the company” or “Fresenius Medical Care”; Frankfurt Stock Exchange: FME / New York Stock Exchange: FMS), the world's largest provider of dialysis products and services, today introduced the 2008K@home...

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Physician Launches MDHearingAid® to Provide Low-Cost Hearing Aids to Americans Who Need to Hear Clearly

November 11, 2011 4:45 am | News | Comments

CHICAGO--(BUSINESS WIRE)--An award-winning physician and professor has launched MDHearingAid®, a company that provides affordable, high-quality hearing aids for people with mild to moderately-severe hearing loss.

Devon Medical Products to Feature Compression Therapy Pumps, Secure European Distributors at 2011 MEDICA World Fair

November 11, 2011 4:42 am | News | Comments

KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Devon Medical Products, a global designer, manufacturer, and distributor of creative, safe, and cost-effective medical devices, today announced it will present its featured product line on the world stage at the 2011 MEDICA World Fair in Düsseldorf, Germany...

St. Jude Medical Portico Transcatheter Valve Demonstrates Promising Results in Feasibility Study

November 11, 2011 4:40 am | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the feasibility study results for the company's Porticoâ„¢ Transcatheter Aortic Heart Valve, presented at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.

MedaPhor announces University of Washington Medical Center in Seattle as first US customer for ScanTrainer

November 11, 2011 4:26 am | News | Comments

CARDIFF, WALES - November 10, 2011 - MedaPhor, the UK-based ultrasound simulation company, is delighted to announce that University of Washington Medical Center in Seattle is the first US hospital to install its revolutionary ScanTrainer ultrasound simulation system.

Flexible Stenting Solutions, Inc. Announces First Implant of the 200 mm FlexStent® Femoropopliteal Self Expanding Stent System

November 10, 2011 5:56 am | News | Comments

EATONTOWN, N.J.--(BUSINESS WIRE)--Flexible Stenting Solutions, Inc. (FSS), a leading developer of next generation peripheral arterial, venous, neurovascular and biliary stents, announced today the successful implantation of its 200 mm FlexStent® Femoropopliteal Self Expanding Stent System...

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OSI Systems Introduces New Anesthesia Gas Monitoring Solution

November 10, 2011 5:52 am | News | Comments

HAWTHORNE, Calif.--(BUSINESS WIRE)--OSI Systems, Inc. (NASDAQ: OSIS), a vertically-integrated provider of specialized electronic products for critical applications in the Security and Healthcare industries, today announced that its Healthcare division, Spacelabs Healthcare...

FDA Clears Enhanced Features on Fresenius Medical Care's 2008T

November 10, 2011 5:50 am | News | Comments

PHILADELPHIA--(BUSINESS WIRE)--At the American Society of Nephrology's Kidney Week 2011, Fresenius Medical Care (NYSE: FMS), the world's largest provider of dialysis products and services, announced that it received U.S. Food and Drug Administration 510 (K) clearance...

Plasma Surgical Introduces the New PlasmaJet® Ultra at Annual AAGL meeting

November 10, 2011 5:47 am | News | Comments

ROSWELL, Ga.--(BUSINESS WIRE)--Plasma Surgical announced today the introduction of its PlasmaJet® Ultra System for hemostatic cutting and coagulation during this week's 40th Global Congress of Minimally Invasive Gynecology sponsored by the American Association of Gynecologic Laparoscopists...

iCAD Announces Recent Adoption of Its Xoft Electronic Brachytherapy System by Leading U. S. Hospitals

November 10, 2011 5:43 am | News | Comments

NASHUA, N.H.--(BUSINESS WIRE)--iCAD, Inc. (Nasdaq: ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapies for the early identification and treatment of cancer, today announced that its Xoft Axxent® eBx™ electronic brachytherapy system...

PROTECT II Demonstrates That Patients Undergoing Extensive Revascularization Benefit the Most from Impella Support

November 10, 2011 5:22 am | News | Comments

DANVERS, Mass. & SAN FRANCISCO--(BUSINESS WIRE)--Abiomed Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today announced the final analysis from the PROTECT II trial at the annual 2011 Transcatheter Cardiovascular Therapeutics (TCT) meeting.

Starkey's AMP Wins Consumer Electronics Show Innovations 2012 Award

November 10, 2011 5:17 am | News | Comments

MINNEAPOLIS--(BUSINESS WIRE)--Starkey Laboratories, Inc., one of the world's leading hearing technology companies, is excited to announce that it has been named an International CES Innovations 2012 Design and Engineering Awards Honoree for its AMPâ„¢ hearing aid.

1st Findings on Exercise Performance with SynCardia's Total Artificial Heart Published in The Journal of Heart and Lung Transplantation

November 10, 2011 5:02 am | News | Comments

TUCSON, Ariz. – Nov. 10, 2011 – In the November issue of The Journal of Heart and Lung Transplantation (JHLT), Virginia Commonwealth University (VCU) Medical Center in Richmond published the first findings demonstrating that physical exercise and measurable rehabilitation are feasible with the SynCardia...

Circadiance Launches Revolutionary New CPAP Tube

November 10, 2011 5:00 am | News | Comments

PITTSBURGH, Nov. 10, 2011 /PRNewswire/ -- Building on the success of their revolutionary soft cloth nasal SleepWeaver CPAP (Continuous Positive Airway Pressure) mask, Circadiance is proud to introduce a mask tube so lightweight and flexible, that CPAP users will hardly know it's there.

Large-Scale Imaging and Brain Mapping Are Topics of Olympus Symposium at Society for Neuroscience Meeting

November 10, 2011 4:58 am | News | Comments

CENTER VALLEY, Pa., November 9, 2011 - Olympus is hosting its second major symposium on Brain Imaging and Brain Mapping in conjunction with the 2011 annual meeting of the Society for Neuroscience (SfN) in Washington DC on November 13. The Olympus Neuroimaging Symposium will be held at...

Cerebral Stethoscope Offers New Tool for Early Detection of Aneurysms

November 10, 2011 4:41 am | News | Comments

ALPINE, N.J., Nov. 9, 2011 /PRNewswire/ -- ProTron Technologies announces a new approach to early detection of aneurysms in vascular systems through the patented Stethotron® Cerebral Stethoscope. In the USA alone, six million people have a brain aneurysm. In 50% of ruptured aneurysms...

Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff - FDA Decisions for Investigational Device Exemption (...

November 10, 2011 3:31 am | by U.S. Food & Drug Administration | News | Comments

This guidance document has been developed to promote the initiation of clinical investigations to evaluate medical devices under FDA?s Investigational Device Exemptions (IDE) regulations, Title 21 Code of Federal Regulations (CFR) Part 812.

Draft Guidance for Industry and Food and Drug Administration Staff - Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including C...

November 10, 2011 3:30 am | by U.S. Food & Drug Administration | News | Comments

This document is intended to provide guidance to FDA staff, clinicians, clinical innovators, and industry on the development and review of Investigational Device Exemption (IDE) applications for early feasibility studies of significant risk devices.

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