Minnesota medical device maker EnteroMedics appeared unfazed by the FDA's response to the company's premarket approval application, anticipating no slowdown in the regulatory process for its landmark Maestro weight-loss implant.
A move to value-based health care, tougher regulations and a lack of resources are challenging medtech companies to be more creative when developing new products and services, and to experiment with new business models. New innovative strategies are now essential if medtech companies are to survive and grow...
The Food and Drug Administration said Monday that it has approved broader use of an innovative artificial heart valve that can be implanted without major surgery, allowing surgeons to insert the implant through multiple pathways. The agency approved revised labeling for Edwards Lifesciences' Sapien heart valve...
FDA Approves Medtronic's Complete 'SE' Vascular Stent for Use in Superficial Femoral and Proximal Popliteal (Leg) ArteriesSeptember 24, 2013 11:42 am | by The Associated Press | News | Comments
Expanding its role in the treatment of peripheral artery disease in the United States, Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has approved the Complete SE (self-expanding) vascular stent for use in the lower extremities -- specifically, the superficial femoral artery (SFA) and proximal popliteal artery (PPA), which carry blood through the upper legs.
Food and Drug Administration officials say they will begin regulating a new wave of applications and gadgets that work with smartphones to take medical readings and help users monitor their health. With the rise of the iPhone, Android and other mobile devices has come a flood of applications designed to help people stay healthy.
AirSonea, the world’s first smartphone-enabled device for monitoring wheeze, was unveiled Tuesday in Melbourne, Australia, by the United States management team of iSonea Ltd. Expected in the United States in 2014, the discreet-in-size and easy-to-use AirSonea is a handheld device that turns a person’s smartphone into a portable wheeze monitor.
Isansys Lifecare Limited, the provider of complete real-time physiological patient data services and systems, today announces the general availability of its CE-marked Patient Status Engine™ – the world’s first plug-and-play continuous wireless vital signs monitoring system complete with clinical apps that can be customised for individual needs.
The threat from a heart attack doesn't end with the event itself. Blockage of blood flow to the heart can cause irreversible cell death and scarring. With transplants scarce, half the people who live through a heart attack die within five years. Scientists are trying to address this problem by engineering cardiac tissue to patch up damaged areas.
In patients with an acute heart attack, remote ischemic conditioning – intermittent inflation of a blood pressure cuff to cut off blood flow to the arm during transportation to hospital for acute balloon dilatation – reduces subsequent cardiac symptoms and mortality after acute heart attack.
A team from the University of Texas at Arlington has used mathematical modeling to develop a computer simulation they hope will one day improve the treatment of dangerous reactions to medical implants such as stents, catheters and artificial joints.
Researchers have made an exciting breakthrough – developing a first-of-its-kind imaging tool to examine myelin damage in multiple sclerosis (MS). An extremely difficult disease to diagnose, the tool will help physicians diagnose patients earlier, monitor the disease’s progression, and evaluate therapy efficacy.
Pacemakers, insulin pumps, defibrillators and other implantable medical devices often have wireless capabilities that allow emergency workers to monitor patients. But these devices have a potential downside: They can be hacked. Researchers at Rice University have come up with a secure way to dramatically cut the risk that an implanted medical device could be altered remotely without authorization.
GS1 Standards can help manufacturers comply with a new regulation released by the FDA that establishes a national unique device identification system for medical devices to increase patient safety. A new GS1 UDI resource Web page is now available to offer GS1 Standards implementation guidance.
Investorideas.com, an investor research portal specializing in investing ideas in leading sectors including biotech and medical technology stocks, issues an exclusive Q&A with Jim Joyce, Chairman and CEO of Aethlon Medical, Inc. (OTCQB: AEMD). Mr. Joyce discusses the recent launch of its new Exosome Sciences, Inc. (ESI) and what that potentially represents to Aethlon and its shareholders.
Theorem Clinical Research Puts Medical Device Expertise on Display at Outsourcing in Clinical Trials New EnglandSeptember 24, 2013 8:00 am | by Business Wire | News | Comments
Theorem Clinical Research, one of the leading CROs in the medical device arena, will be in Boston for the Outsourcing in Clinical Trials New England conference, Oct. 1-2 at the Westin Boston Waterfront in Boston. “A whole section of the agenda is devoted to medical devices and the industry-specific challenges sponsors face in gaining regulatory approval...