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.
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.
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.
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.
Teleflex Receives FDA Clearance for ARROW GPSCath Balloon Dilatation Catheters in Higher RBP and 80 cm LengthsJuly 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.
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, 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, 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 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.
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' 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.
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.
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.
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.
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.”
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.
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.
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 SystemJuly 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.
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.
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.
MicroVention Announces First Trial Enrollment In Their U.S. Clinical Trial Of Its New Dual-Layer Stent For Cerebral Aneurysm Flow DiversionJuly 22, 2013 10:00 am | by The Associated Press | News | Comments
MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, announced earlier last week that they successfully completed their first enrollment in a multi-center, prospective, pivotal U.S. clinical trial to demonstrate the safety and efficacy of its FREDT flow diversion system (FREDT-Flow Re-Direction Endoluminal Device) for treating intracranial aneurysms.
Biosan Medical Receives U.S. Patent for Its Novel Device and Method of Treating the Deadliest Type of Stroke, Subarachnoid Hemorrhage (SAH), and Alzheimer’s DiseaseJuly 22, 2013 9:24 am | by Business Wire | News | Comments
Biosan Medical, an emerging medical device company, announced today that it has been issued U.S. Provisional Patent No. 61,957,293 for its revolutionary Ventritek105® Stroke Treatment Device and Method (“Device & method for CSF auto-transfusion therapy for the treatment of SAH (subarachnoid hemorrhage), Alzheimer’s Disease & other Neuro-Degenerative CNS diseases”).
Corindus Vascular Robotics announced today that Sanford Aberdeen Medical Center in Aberdeen, S.D. became the first hospital to perform a Robotic Angioplasty for a patient with an acute heart-attack, achieving a far better door-to-balloon time than the national standard.
ValveXchange has its sights set on winning regulatory approval in Europe for its Vitality device, a product the company touts as the 1st serviceable bioprosthetic heart valve. Clinical trial enrollment to support European CE Mark approval wrapped up last month, and ValveXchange submitted all of its paperwork to the regulatory body DERKA Certification this week, according to a press release.