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TAVI: Edwards wins FDA approval to begin clinical studies of next-gen Sapien 3 valve

August 5, 2013 12:29 pm | by Mass Device | News | Comments

Medical device giant Edwards Lifesciences is powering forward with its solo-hold on the U.S. market for transcatheter aortic valve implantation systems, now preparing to launch an Investigational Device Exemption clinical trial of its next-generation Sapien 3 TAVI device.

Cardiologist must cough up $17M in false Medicare billing case

August 2, 2013 1:13 pm | by Mass Device | News | Comments

A Washington, D.C., cardiologist was hit with a $17 million judgment after being found guilty of submitting false claims for nuclear imaging tests to Medicare and state health programs. Federal authorities accused Dr. Ishtiaq Malik of double-billing and submitting false claims for myocardial perfusion studies or "nuclear stress tests."

Abiomed Surpasses 15,000 Impella Patients in the United States

August 2, 2013 8:45 am | by Globe Newswire | News | Comments

Abiomed, Inc., a leading provider of breakthrough heart support technologies, today reported that physicians have implanted more than 15,000 Impella® pumps in U.S. patients requiring hemodynamic support. The 15,000th Impella procedure took place at Mercy General Hospital in Sacramento, California with an Impella pump that provided prophylactic circulatory support.

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Thubrikar’s Next-Generation TAVI system surpasses ISO requirement for durability and achieves other milestones

August 1, 2013 6:27 pm | by Business Wire | News | Comments

Thubrikar Aortic Valve, a privately held medical device company developing a next-generation transcatheter aortic valve implantation (TAVI) system, announced today that its Optimum TAV has surpassed 200 million cycles in an ongoing durability test - which simulates over 5 years in humans and meets the requirement set by the International Organization for Standardization (ISO) - in a third party GLP study.

FDA expands clearance for Teleflex's Arrow balloon dilatation catheters

August 1, 2013 1:29 pm | by Mass Device | News | Comments

Teleflex (NYSE:TFX) won FDA clearance for expanded sizes and uses of its Arrow GPSCath Balloon Dilatation catheter, a device the company picked up during the 2012 buyout of Hotspur Technologies. The FDA win lets Teleflex sell the catheter in new 80 cm lengths and in a higher burst pressure rating.

Camera Crushes Patient; Sparks Recall

August 1, 2013 12:40 pm | by David Mantey, Executive Editor, MDT | News | Comments

This week, the U.S. Food and Drug Administration (FDA) announced the recall of GE Healthcare’s Nuclear Medicine Systems were recalled following an incident at a VA Medical Center in which a patient died due to injuries sustained while being scanned.

Solutions for Improving First Aid in Cardiorespiratory Arrests

July 31, 2013 11:52 am | by Elhuyar Fundazioa | News | Comments

An algorithm capable of diagnosing heart rhythm with just 3 seconds’ worth of signal, and the demonstration that it is possible to come up with the diagnosis without stopping cardiac massage, constitute the types of solutions and proposals being developed by researchers in the Signal and Communications Group of the Faculty of Engineering in Bilbao.

Stem Cells in Urine Easy To Isolate and Have Potential for Numerous Therapies

July 31, 2013 10:12 am | by Wake Forest Baptist Medical Center | News | Comments

Could harvesting stem cells for therapy one day be as simple as asking patients for a urine sample? Researchers at Wake Forest Baptist Medical Center's Institute for Regenerative Medicine and colleagues have identified stem cells in urine that can be directed to become multiple cell types.

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Teleflex Receives FDA Clearance for ARROW GPSCath Balloon Dilatation Catheters in Higher RBP and 80 cm Lengths

July 30, 2013 5:00 pm | by Business Wire | News | Comments

Teleflex Incorporated (NYSE:TFX), a leading global provider of medical devices for critical care and surgery, has announced that its subsidiary Hotspur Technologies, Inc., which Teleflex acquired in June 2012, received FDA 510(k) clearance to market the company’s ARROW ® GPSCath ® Balloon Dilatation Catheters in Higher Rated Burst Pressure (RBP) and 80 cm lengths.

University Researches Effectiveness of Telehealth

July 29, 2013 11:27 am | by University of Salford | News | Comments

The University of Salford has carried out a systematic review of the literature to research the effectiveness of telehealth on clinical outcomes, cost effectiveness and patient experience. Telehealth allows patients to monitor long-term health conditions from home, reducing visits to a clinic or hospital.

Advanced Catheter Therapies Awarded Patent

July 29, 2013 9:48 am | by The Associated Press | News | Comments

Advanced Catheter Therapies, Inc. (ACT) has announced that the United States Patent and Trademark Office has issued U.S. Patent No. 8398589 B2 for its catheter technology. ACT is a research and development medical device company with a portfolio of innovative catheter technologies initially targeting vascular disease and restenosis.

InspireMD Announces First Patient Enrolled in U.S. Registration Trial for MGuard™ Prime EPS

July 29, 2013 9:00 am | by PR Newswire | News | Comments

InspireMD, Inc. (NYSE MKT: NSPR) ("Inspire" or the "Company"), a leader in embolic protection stents, said the first patient has been enrolled in the Master II IDE clinical trial to evaluate the safety and effectiveness of the MGuard™ Prime Embolic Protection Stent (EPS) in patients suffering from ST Elevation Myocardial Infarction (STEMI).  

Cook Medical Partners with IU Health for Study on Peripheral Arterial Disease Treatment

July 29, 2013 8:00 am | by Business Wire | News | Comments

Cook Medical has partnered with IU Health to evaluate a potential treatment for peripheral arterial disease (PAD), a vascular disease of the legs. The treatment involves the placement of a stent, which is a small, metal mesh tube that is inserted into the artery to treat blockages of blood flow.

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Hacker Discussing Hacking Pacemakers Dies

July 27, 2013 1:29 am | by Sudhin Thanawala - Associated Press | News | Comments

A prominent hacker who discovered a way to have automatic teller machines spit out cash and was set to deliver a talk about hacking pacemakers and other wireless implantable medical devices has died in San Francisco, authorities and his employer said.

Vascular Solutions posts profits, boosts guidance estimates

July 25, 2013 6:05 pm | by Mass Device | News | Comments

Vascular Solutions' Q2 earnings landed exactly within analyst expectations, ending the company's long streak of beating the Street. Despite driving profits up almost 20% and boosting guidance estimates to reflect healthy revenue, Wall Street responded by sending share prices down 0.7% by the end of the day.

New Blood Clot Removal System Successfully Restores Blood Flow

July 25, 2013 3:47 pm | by Cardiovascular Institute of the South | News | Comments

Dr. Nick Cavros, interventional cardiologist with Cardiovascular Institute of the South (CIS) at Lafayette General Medical Center in Lafayette, Louisiana, used a new hand-held mechanical aspiration system to remove blood clots and increase blood flow.

From Gold, a New Way to Control Blood Clotting

July 25, 2013 1:33 pm | by Anne Trafton, MIT | News | Comments

Using gold nanoparticles, MIT researchers have devised a new way to turn blood clotting on and off. The particles, which are controlled by infrared laser light, could help doctors control blood clotting in patients undergoing surgery, or promote wound healing.

Clinical Trial Completed on New Two-Part Heart Valve

July 25, 2013 11:08 am | by ValveXchange | News | Comments

Surgeons in Europe have completed clinical trials on the world’s first serviceable bioprosthetic heart valve, paving the way for the CE mark and commercial sale of an advanced heart valve that eliminates many common problems for cardiac valve patients.

‘Standards’ for Home Healthcare

July 23, 2013 4:44 pm | by Todd Konieczny, Assistant Chief Engineer, Americas Region; Technical Manager, Medical Division, Intertek | Blogs | Comments

The following standard must be met for all medical products intended to be used in the home: IEC 60601-1-11, which is “Medical Electrical Equipment—Part 1-11: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment.”

Researchers Put Squeeze on Cells to Deliver

July 23, 2013 11:12 am | by National Institute of Biomedical Imaging and Bioengineering | News | Comments

Imagine being able to redirect powerful immune cells to fight cancer. How about reprogramming a diabetic’s skin cell into a cell that could manufacture the insulin their pancreas no longer produces? These are major health problems and medical challenges that may be more achievable with a new fundamental technology that gets vital control molecules into cells faster, safer, and more effectively.

Steering Stem Cells with Magnets

July 23, 2013 10:19 am | by Emory University | News | Comments

Magnets could be a tool for directing stem cells’ healing powers to treat conditions such as heart disease or vascular disease. By feeding stem cells tiny particles made of magnetized iron oxide, scientists at Emory and Georgia Tech can then use magnets to attract the cells to a particular location in a mouse's body after intravenous injection.

BMC Surgeon Recommends Off-Pump Coronary Artery Bypass Grafting Be Abandoned

July 23, 2013 10:04 am | by Boston University Medical Center | News | Comments

In a Special Report in the current issue of Circulation, Boston Medical Center cardiothoracic surgeon Harold Lazar, MD, has found that off-pump coronary artery bypass graft (OPCAB) surgery has failed to show any significant improvement in short-term morbidity or mortality as compared to the traditional on-pump coronary artery bypass graft (CABG) surgery.

Brookhaven Medical Makes $5 Million Investment In CreatiVasc Medical’s New Dialysis Device and System

July 23, 2013 10:00 am | by Business Wire | News | Comments

Brookhaven Medical, Inc., an Atlanta based medical device company with interests in dialysis devices and advanced wound care, announced today that it has made a strategic investment of up to $5 million into CreatiVasc Medical, Inc. of Greenville, South Carolina.

Temperature-Resistant Microchip to be Used for UDI Compliance for Implantables

July 23, 2013 8:30 am | by Business Wire | News | Comments

Digital Angel Corporation, following its recent share exchange with VeriTeQ Acquisition Corporation, announced that VeriTeQ filed a provisional patent with the U.S. Patent and Trademark Office in September 2012 for a microchip that is able to withstand high temperatures in order to make it compatible with the sterilization processes involved in the manufacturing of implantable medical devices.

IEC 60601-2-34 Issue 3: Changes to Recovery Test

July 22, 2013 2:11 pm | by Jeff Lind, CEO & Jose Cabanillas, Hardware Engineer, Compliance West USA | Compliance West USA | Articles | Comments

The IEC has made a change to the Recovery Test, 60601-2-34. Issue 3 offers modifications that make it more beneficial for engineers as a custom test system is no longer required for this specific test. This article reviews the full breadth of the test and how it can impact medical device manufacturers.

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