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FDA Updates Guidance on Pulse Oximeter Applications

March 7, 2013 9:29 am | by Mass Device | News | Comments

The FDA issued new guidance governing premarket notification submissions for pulse oximeters. The new guidelines apply to all 510(k) submissions for the non-invasive blood oxygen level and pulse rate measuring devices. In the guidance, published March 4, the FDA specified new rules for identifying, testing and assuring safety for the systems.

First U.S. Installation of Centricity Cardio Enterprise Complete

March 7, 2013 9:09 am | by The Associated Press | News | Comments

SAN FRANCISCO--(BUSINESS WIRE)--Mar 7, 2013--GE Healthcare today announced the first U.S. installation of its Centricity™ Cardio Enterprise solution at Oklahoma State University Medical Center. This robust IT solution supports GE Healthcare’s enterprise imaging strategy by offering cardiologists a...

Study: Experimental Anorexia Treatment with Deep Brain Stimulation May Provide Lasting Results

March 7, 2013 8:59 am | by Mass Device | News | Comments

In what some are calling "a world 1st," researchers reported some success in treating severe anorexia patients via implanted electrodes that delivered electrical energy to the regions of the brain associated with emotion. The study enrolled 6 patients to receive the experimental treatment...

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Philips Healthcare and Infraredx Introduce Solution to Enable Seamless Integration of TVC Imaging System with Philips’ Allura Xper Systems

March 7, 2013 8:30 am | by The Associated Press | News | Comments

ANDOVER, Mass. & BURLINGTON, Mass.--(BUSINESS WIRE)--Mar 7, 2013--Royal Philips Electronics (NYSE: PHG, AEX: PHI) and Infraredx, Inc., a medical device company committed to advancing the diagnosis and management of coronary artery and other vascular diseases, today announced the availability...

In Vitro Diagnostics Markets Grow at Double the Pace of Pharma Markets in Shift toward Globalization

March 7, 2013 8:04 am | by PR Newswire | News | Comments

Global in vitro diagnostics markets are a bright spot in the healthcare industry largely due to the increasing focus on global expansion. This is particularly seen in emerging markets that continue to gain steam as markets flatten. This briefing, featuring a live Q&A with the industry analyst, will explore the IVD market dynamics in these and other key regions globally.

Clinical Trial Results for Dune Medical Devices' MarginProbe@ System Presented at 66th Annual SSO Cancer Symposium

March 7, 2013 8:01 am | by The Associated Press | News | Comments

Dune Medical Devices, Inc., announced today that results from the pivotal clinical trial for the MarginProbe System, Dune's breakthrough intra-operative tissue assessment tool for early-stage breast cancer surgery, were presented at the 66th Annual Society of Surgical Oncology (SSO) Cancer ...

New U.S. Market Data Shows ICU Medical's Needlefree IV Connector Technology Chosen More than Twice as Often as Any Other

March 7, 2013 8:00 am | by PR Newswire | News | Comments

SAN CLEMENTE, Calif., March 7, 2013 /PRNewswire/ -- ICU Medical, Inc. (NASDAQ:ICUI) today announced that its family of needlefree intravenous (IV) connectors was chosen by U.S. healthcare providers more than twice as often as any other connector technology according to newly released...

'Disappearing Stent is a Dream Come True' - World Leaders at India Live Cardiology Conference 2013

March 7, 2013 6:13 am | by PR Newswire | News | Comments

For its ability to unblock and then make arteries return to natural form, the recently launched bioresorbable vascular scaffold (BVS and also known as disappearing stent) is being hailed as the 4th revolution in management of coronary artery disease at India's biggest conference on interventional cardiology.

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CASMED Announces Fourth Quarter and Full-Year 2012 Financial Results

March 7, 2013 2:45 am | by GlobeNewswire | News | Comments

CAS Medical Systems, Inc., a leader in medical devices for non-invasive patient monitoring, today reported financial results for the three and 12 months ended December 31, 2012. Net sales were $6.0 million for the fourth quarter and $22.7 million for the year, compared with $5.3 million and $22.5 million in comparable prior-year periods, respectively.

Class I Medical Device Recall: Ad-Tech Medical Instrument Corporation, Macro Micro Subdural Electrodes

March 7, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

There is a concern the microelectrodes are defective and may cause injury to the brain. As a result, there is the potential for scraping (abrasion) of brain tissue and for broken pieces to remain in the brain tissue when the physician removes the...

Boston Scientific Updates PREVAIL Late Breaking Clinical Trials Presentation

March 6, 2013 4:34 pm | by PR Newswire | News | Comments

NATICK, Mass., March 6, 2013 /PRNewswire/ -- The Boston Scientific Corporation (NYSE: BSX) PREVAIL clinical trial results will be presented in a Late-Breaking Clinical Trial presentation at the 62nd Annual Scientific Sessions of the American College of Cardiology, and will include all...

Portfolio of Medical Devices Receives Lemelson-MIT Student Prize

March 6, 2013 3:08 pm | by Cone Communications | News | Comments

Nikolai Begg grew up in a box of LEGO bricks and hasn't stopped tinkering since. Today he is an accomplished inventor with a portfolio of novel medical devices. Begg is the recipient of the prestigious $30,000 Lemelson-MIT Student Prize for his inventions that are making surgical procedures less invasive.

New Opportunities for 3D Technology in Medicine

March 6, 2013 3:05 pm | by Fraunhofer | News | Comments

Until now, physicians have largely been skeptical of the advantages of 3D technology. But this may be about to change: the findings of a new study show that even experienced surgeons stand to benefit from the third dimension.

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Improved Ultrasound Imaging

March 6, 2013 3:01 pm | by Texas A&M University | News | Comments

Ultrasound technology could soon experience a significant upgrade that would enable it to produce high-quality, high-resolution images, thanks to the development of a new key material by a team of researchers that includes a professor in the Department of Biomedical Engineering at Texas A&M University.

Cardiac Science Celebrates 100-Year Anniversary

March 6, 2013 2:55 pm | by PR Newswire | News | Comments

WAUKESHA, Wis., March 6, 2013 /PRNewswire/ -- Cardiac Science Corporation, an Opto Circuits group company and a global leader in automated external defibrillators (AEDs) and diagnostic cardiac monitoring devices, announced the start of its 100-year anniversary celebration with a...

Vision-Sciences to Present at Canaccord Genuity Musculoskeletal Conference

March 6, 2013 2:45 pm | by GlobeNewswire | News | Comments

Vision-Sciences, Inc., a leading provider of unique flexible endoscopic products utilizing its proprietary sterile disposable EndoSheath® technology, today announced that Cynthia Ansari, President and Chief Executive Officer, will present at 4:00 PM Central Standard Time at the Canaccord Genuity Musculoskeletal Conference in Chicago on Tuesday, March 19th at the Westin Michigan Avenue.

FDA Releases Draft of Sunshine Law Financial Disclosure Guidelines

March 6, 2013 2:29 pm | by Mass Device | News | Comments

The FDA published a draft of the Sunshine Act financial disclosure guidelines that will take full effect by August 1, 2013. The 35-page document details all physician-relationship rules companies will have to follow when applying for marketing applications with the FDA.

Boston Scientific hesitates to release full safety results for Watchman heart implant

March 6, 2013 1:27 pm | by Mass Device | News | Comments

Officials at Boston Scientific (NYSE:BSX) announced this week that they would reveal only limited patient safety results when they present data from a clinical trial of the Watchman stroke prevention implant at the American College of Cardiology conference this week.

Pathfinder and InnerOptic Announce Technology Integration to Enhance Visualization and Outcomes in Liver Surgery

March 6, 2013 12:39 pm | by The Associated Press | News | Comments

NASHVILLE, Tenn. & HILLSBOROUGH, N.C.--(BUSINESS WIRE)--Mar 6, 2013--Pathfinder Technologies, the developer of computer-assisted navigation products, and InnerOptic Technology, the developer of ultrasound-guided navigation products, announced a licensing agreement today that will enable...

Symplicity(TM) Renal Denervation System One of First Devices Accepted to Participate in Concurrent Review for Joint FDA Premarket Approval and Medicare National Coverage Determination

March 6, 2013 12:18 pm | by The Associated Press | News | Comments

Medtronic, Inc. (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have accepted the inclusion of the Symplicity(TM) renal denervation system for treatment-resistant hypertension in their parallel review program...

HD Medical, Inc. Launches US Business Operations

March 6, 2013 8:05 am | by The Associated Press | News | Comments

SAN FRANCISCO--(BUSINESS WIRE)--Mar 6, 2013--At ACC.13, HD Medical Inc. a recently formed medical device research and development innovator headquartered in Santa Clara, CA, today announces the launch of US business operations. This new company is delivering revolutionary diagnostic technologies...

Study: Surefire Medical's Technology Improves Delivery Of Embolics In Cancer Treatment

March 6, 2013 6:17 am | by Bio-Medicine.Org | News | Comments

Surefire Medical 's new infusion system maximizes delivery of drugs directly to the tumor site while minimizing potential damage to non-target organs, according to a new study .  The ability to more safely and efficiently deliver embolic agents to target tumors locally marks a significant advance in radiation oncology procedures a...

Global Gynecological Devices Market is Expected to Reach USD 5.3 Billion by 2018: Transparency Market Research

March 6, 2013 4:36 am | by Bio-Medicine.Org | News | Comments

As per the new market report published by Transparency Market Research "Gynecological Devices Market  (Surgical Devices, Endometrial Ablation Devices, Female Sterilization and Contraception Devices, Vaginal Speculum, Tenaculum, Biopsy Forceps, Diagnostic Imaging Systems and Gynecological...

Visceral Fat Causally Linked to Intestinal Cancer

March 6, 2013 12:05 am | by AACR | News | Comments

Visceral fat, or fat stored deep in the abdominal cavity, is directly linked to an increased risk for colon cancer, according to data from a mouse study published in Cancer Prevention Research, a journal of the American Association for Cancer Research.

Guidance for Industry and FDA Staff - Investigational Device Exemption (IDE) Guidance for Retinal Prostheses

March 6, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

This guidance is intended for FDA reviewers and members of industry who intend to submit an investigational device exemption (IDE) to the FDA to conduct feasibility and/or pivotal human clinical trials of their retinal prostheses in the United States...

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