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FDA Proposes Expedited Access Program for Devices that Address Unmet Medical Needs

April 22, 2014 2:46 pm | by FDA | Comments

The U.S. Food and Drug Administration proposed a new program to provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology...

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Smarter Incentives for Inventors Could Spur Medical Innovation, Cut U.S. Healthcare Spending

April 22, 2014 12:19 pm | by RAND | Comments

To help rein in massive healthcare spending, a new RAND study concludes that U.S. policymakers should urgently find ways to incentivize pharmaceutical companies and device makers to develop products that produce more value. Instead of... 

Tracking Oxygen in the Body

April 22, 2014 11:59 am | by Anne Trafton, MIT News Office | Comments

Unlike healthy cells, cancer cells thrive when deprived of oxygen. Tumors in low-oxygen environments tend to be more resistant to therapy and spread more aggressively to other parts of the body. Measuring tumors’ oxygen levels could help...

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Gold Nanoparticles Help Target Breast Cancer Gene Segments in Living Cell

April 22, 2014 11:41 am | by Natalie van Hoose, Purdue University | Comments

Purdue University researchers have developed a way to detect and measure cancer levels in a living cell by using tiny gold particles with tails of synthetic DNA. A team led by Joseph Irudayaraj, professor of agricultural and biological...

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Electronic Transdermal Patch Is Winner at French ‘Worldwide Innovation Challenge’

April 22, 2014 10:58 am | by Rhenovia Pharma SAS | Comments

Rhenovia Pharma, a biotechnology company specialized in the application of biosimulation to the research and development of new medicinal products, today announces that its SMARTT e-Patch project has won an award at the ‘World Innovation...

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Students Take Clot-Buster for a Spin

April 22, 2014 10:48 am | by Rice University | Comments

In the hands of some Rice University senior engineering students, a fishing rod is more than what it seems. For them, it’s a way to help destroy blood clots that threaten lives. Branding themselves as “Team Evacuator,” five students have...

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Photos of the Day: Blood Clot Buster

April 22, 2014 10:48 am | by Rice University | Comments

Rice University engineering students have created a device to break up blood clots in the bladders of patients. Rice senior Lung-Ying Yu demonstrates how the device attached to a fishing rod and reel assembly breaks up clumps of gelatin...

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First U.S. Implant of ICD System that Allows Full-Body MRI Scans

April 22, 2014 10:22 am | by Medtronic | Comments

Medtronic has announced the first U.S. implant of the Evera MRI SureScan implantable cardioverter-defibrillator (ICD) System, following U.S. Food and Drug Administration (FDA) approval for its Investigational Device Exemption (IDE) application...

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Cloaked DNA Nanodevices Survive Pilot Mission

April 22, 2014 10:04 am | by Wyss Institute | Comments

It's a familiar trope in science fiction: In enemy territory, activate your cloaking device. And real-world viruses use similar tactics to make themselves invisible to the immune system. Now scientists at Harvard's Wyss Institute for...   

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Intuitive Surgical’s da Vinci Sp System Earns FDA Clearance

April 22, 2014 9:55 am | by Globe Newswire | Comments

Intuitive Surgical, Inc., the global leader in robotic-assisted minimally invasive surgery, has announced it has received FDA 510(k) clearance for the da Vinci Sp Surgical System, which is designed to expand the Company's single-incision...

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Study: Optimal Commercial Operations and Analytics Increasingly Important for Medtech Companies

April 22, 2014 9:26 am | by ZS Associates | Comments

As medical technology purchasing decisions shift from individuals or hospital departments to ever-larger Integrated Delivery Networks (IDNs), key account management in today’s medical technology companies is a top priority – and commercial...

Federal Appeals Court Agrees to Medtronic Request to Postpone Injunction

April 22, 2014 9:18 am | by Medtronic | Comments

The Federal Circuit Court of Appeals today granted a request from Medtronic, Inc. to postpone the implementation of an injunction that would have prevented the company from selling its CoreValve System in the United States. This means the...

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Luoxis Awarded Health Canada Approval for RedoxSYS™ Diagnostic System

April 22, 2014 8:26 am | by PR Newswire | Comments

Ampio Pharmaceuticals, Inc., has announced that its subsidiary Luoxis, an in vitro diagnostics company, has obtained Health Canada Class II Medical Device approval for its RedoxSYS™ Diagnostic System, the company's blood-based platform for...

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Smiths Medical Launches Pneupac paraPAC plus in U.S. and Canada

April 22, 2014 8:23 am | by The Associated Press | Comments

Smiths Medical, a leading global medical device manufacturer, today announced the launch of its Pneupac paraPAC plus ventilator in the U.S. and Canada. The ventilator, cleared by the FDA and Health Canada, has been used clinically since...

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Aperion Biologics, Inc. Granted CE Mark for Z-Lig ACL Replacement Device

April 22, 2014 3:30 am | by PR Newswire | Comments

Aperion Biologics, Inc. was granted the CE Mark approval for its lead product, the Z-Lig ACLR device, to be used by surgeons in the European Union and other territories that accept the CE Mark. The Z-Lig is the first engineered biologic...

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