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FDA selects three renal device projects for new Pathway program

A UCSF-led effort to create an implantable artificial kidney for dialysis patients has been selected as one of the first projects to undergo more timely and collaborative review at the Food and Drug Administration.

10 Apr 2012

Three NJIT EDC high-tech companies win top awards at 2012 Venture Conference

Three high-tech companies based at NJIT's Enterprise Development Center (EDC) took top awards at the recent 2012 Venture Conference sponsored by the New Jersey Technology Council.

10 Apr 2012

Three ESRD products chosen for FDA's Innovation Pathway program

Three products for patients with end stage renal disease (ESRD) have been chosen to participate in the FDA's Innovation Pathway, an evolving system designed to help medical devices reach patients in a safe, timely and collaborative manner.

10 Apr 2012

ReCor Medical provides updated data from REDUCE Percutaneous Renal Denervation System study

ReCor Medical, an emerging medical device company, disclosed today updated data for the REDUCE First-In-Man clinical study of its PARADISE (Percutaneous Renal Denervation System) ultrasound platform for achieving renal denervation.

10 Apr 2012

Medutech to market ETView's VivaSight airway management platform

ETView Medical, Ltd. announced today that it has entered into a distribution agreement with Medutech Co., Ltd..

9 Apr 2012

Synapse Medical acquires another MicroThermX Microwave Ablation System

BSD Medical Corporation, a leading provider of medical systems that utilize heat therapy to treat cancer, announced today that the Company has sold an additional MicroThermX Microwave Ablation System to Synapse Medical Ltd.

9 Apr 2012

Derma Sciences closes underwritten registered direct offering

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, today announced that it closed an underwritten registered direct offering of 2,125,000 shares of common stock at a price of $9.25 per share on April 5, 2012.

9 Apr 2012

NINDS awards NeuroSigma Phase I grant to develop TFN-covered stents

NeuroSigma, Inc., a Los Angeles-based medical device company, today announced it has been awarded a Phase I NIH-STTR grant from the National Institute of Neurological Disorders and Stroke (NINDS) for the further development of its Thin-Film Nitinol (TFN)-covered stent for the potential treatment of brain aneurysms.

9 Apr 2012

VasoNova receives BSI CE certification for Arrow VPS system

Teleflex Incorporated, a leading global provider of medical devices for critical care and surgery, has announced that its VasoNova Inc. subsidiary has been issued CE certification from its notified body, the British Standards Institution (BSI), to market the company's Arrow VPS system to the European Union.

9 Apr 2012

Sangui patent-based chronic wound spray now available

Based on a patent by Sangui, the technology for a spray aiming at improved healing of chronic wounds is now available. According to a notification by SastoMed GmbH a certification as class III medical product was granted. Global licensee SastoMed will be in charge of marketing and distribution.

7 Apr 2012

Cost of preventive exams varies as much as 700%, report finds

The health law seeks to make preventive screening and procedures available to more people, but it could come at a high cost.

7 Apr 2012

Heart Rhythm Journal manuscript by Dr. Hauser inaccurate and biased, says St. Jude Medical

St. Jude Medical, Inc., a global medical device company, today announced it is seeking a retraction of the manuscript accepted for publication in the Heart Rhythm Journal by Dr. Robert Hauser, et al., titled, "Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads."

7 Apr 2012

FDA grants IDE approval for Arteriocyte's Magellan MAR01 Phase I Compartment Syndrome clinical trial

Arteriocyte, a leading biotechnology company with offices in Cleveland, Ohio and Hopkinton, Massachusetts announced today approval from the Food and Drug Administration (FDA) to initiate a Phase I clinical trial using its Magellan MAR01 technology in the treatment of Compartment Syndrome.

7 Apr 2012