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FDA reauthorization bill sails through Senate

Showing unusual bipartisan spirit, the Senate passed a massive FDA user-fee reauthorization bill Thursday designed to prevent drug shortages and speed federal approval of medicines, including lower-cost generic versions.

25 May 2012

Philips, GE Healthcare applaud FCC for Medical Body Area Networks

GE Healthcare and Royal Philips Electronics applaud the Federal Communications Commission (FCC) today for its action allocating protected spectrum for wireless medical devices, called Medical Body Area Networks (MBANs), which could revolutionize the way patients are monitored and help eliminate the restrictive cables that tether patients to hospital beds.

25 May 2012

Positive Results for Pulsar Stent in Clinical Study – BIOTRONIK announces

The six-month results from the prospective, multicenter, single-arm 4EVER study demonstrate efficacy and safety of BIOTRONIK's Pulsar Stent System in 120 superficial femoral artery (SFA) patients. Analysis of the 120 patients showed excellent device performance, very promising patency rates and convincing evidence of the benefits of lower limb intervention on a 4F platform. Although only the interim results were presented at the Leipzig Interventional Course (LINC 2012) in Leipzig, Germany, analysis of the full cohort has recently been made available.

24 May 2012

Halo Healthcare acquires assets of NeoMatrix

Halo Healthcare, Inc. announces it has acquired the assets of NeoMatrix, LLC and has restructured the Company, including engaging a new CEO and management team, appointing a new Board of Directors, and relaunching the HALO diagnostic device for breast cancer risk assessment.

24 May 2012

Strategies, views on the health law's future vary depending on politics

Congressional Republicans continue to appear divided over what their strategy should be if the Supreme Court strikes down all or part of the health law. More immediately, though, Sen. Orrin Hatch, R-Utah, is targeting the measure's device tax as part of the Senate's consideration of a bill that would reauthorize the Food and Drug Administration user fees.

24 May 2012

Nevro to initiate Senza HF-SCS System study for chronic pain

Nevro Corp., a medical device company focused on achieving improved pain relief for patients suffering from debilitating chronic pain, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for initiation of its SENZA-RCT study, a U.S. prospective, randomized, controlled pivotal clinical trial evaluating the safety and efficacy of Nevro's high-frequency spinal cord stimulation system for the treatment of chronic pain.

24 May 2012

Enrollment complete in Baxano’s iO-Flex System study

Baxano, Inc., a Silicon Valley based medical device company and manufacturer of the iO-Flex System used in spinal decompression surgery, today announced it has completed enrollment in its iO-Flex Study.

23 May 2012

AUA includes percutaneous tibial nerve stimulation in OAB treatment guidelines

Uroplasty, Inc., a medical device company that develops, manufactures and markets innovative proprietary products for the treatment of voiding dysfunctions, today announced that the American Urological Association (AUA) issued a clinical guideline titled "Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults," which includes percutaneous tibial nerve stimulation (PTNS) as an integral part of the care path for overactive bladder (OAB) treatment.

22 May 2012

The Patient Status Engine™ – Industry’s First Cloud-Based Wireless Sensor Vigilance System for Real-time and Predictive Patient Status – Introduced by Isansys

Isansys Lifecare Limited, the provider of complete real-time physiological patient data services and systems, today announces the introduction of its Patient Status Engine™ – the first cloud-based patient digitization and analytic solution for monitoring and predicting the present and future clinical status of patients anytime, anywhere. The introduction of the Patient Status Engine provides the platform for Isansys’ “Vitals as a Service™” solution, which is now offered for priority beta deployments in hospitals and other healthcare facilities.

From Isansys Lifecare Ltd. 21 May 2012

Mo. legislators reportly reach compromise on abortion coverage bill

The St. Louis Beacon reports that the legislature might take up a bill Friday that strips controversial provisions passed by the House earlier in the week.

19 May 2012

Positive results from CardioKinetix Parachute system study on heart failure

CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced two-year clinical results for the first-of-its-kind catheter-based Parachute Ventricular Partitioning Device, a Percutaneous Ventricular Restoration (PVR) therapy for patients with ischemic heart failure.

19 May 2012

UK-led technologies set to transform treatments on the NHS

Video games, pioneering gene therapies and new medical devices are set to transform treatments on the NHS, with support from the Department of Health and the Wellcome Trust.

19 May 2012

New equipment guides from DOTmed

DOTmed.com, Inc., the Internet's largest marketplace for new and used medical equipment and parts, has introduced DOTmed New Equipment Guides in print and online.

18 May 2012

Northwestern University SCS now offers MSRC program

To help professionals succeed in the growing field of regulatory compliance, Northwestern University School of Continuing Studies now offers the Master of Science in Regulatory Compliance (MSRC) program.

18 May 2012

CCH, BGU launch collaboration to address lack of pediatric-specific medical devices

A collaboration to address the lack of medical devices designed specifically for children is being launched by Cincinnati Children's Hospital Medical Center (CCH) in Ohio and Ben-Gurion University of the Negev (BGU) in Beer-Sheva, Israel. The goal is to improve health outcomes for children by ensuring device design that is customized to meet childrens' unique physiological differences and medical needs.

17 May 2012

CryoLife acquires Hemosphere

CryoLife, Inc., a leading medical device company focused on cardiac and vascular surgery, announced today that it has completed its previously announced acquisition of Hemosphere, Inc.

17 May 2012

NeuroSigma Subsidiary sees potential for Thin-Film Nitinol in next-generation flow-diverting stents for treating intracranial aneurysms

NeuroSigma, Inc., a Los Angeles-based medical device company, today announced that its majority-owned subsidiary, NSVascular, Inc. (NSV), acquired a portfolio of patents and related trade secrets covering the fabrication of Thin-Film Nitinol (TFN) from TiNi Alloy Company, including U.S. Patent No. 6,746,890 entitled “Three Dimensional Thin Film Devices and Methods of Fabrication,” an important piece of the portfolio covering the production of three-dimensional TFN constructs.

16 May 2012

Sorin receives PMDA authorization to market MEMO 3D ring

Sorin Group, a global medical device company and a leader in the treatment of cardiovascular diseases, announces that it received authorization from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to market its MEMO 3D Semi-Rigid Annuloplasty Ring.

16 May 2012

BiO2 Medical receives CE Mark approval for Angel Catheter to prevent PE

BiO2 Medical, Inc. a Texas based medical device manufacturer with corporate offices in San Antonio, Texas, and R&D and manufacturing operations in Golden, Colorado, announced today that it has received CE Mark approval for the Angel Catheter, a Nitinol Inferior Vena Cava (IVC) filter, permanently attached to a central venous catheter (CVC) for the use of preventing Pulmonary Embolism (PE) in critically ill patients.

16 May 2012

Derma Sciences first quarter net sales increase 6% to $15.3 million

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, today reported financial and operating results for the three months ended March 31, 2012.

15 May 2012