Medical Devices News and Research

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U.S. market for urological devices to reach over $5.4 billion in 2016

According to a new global report series by iData Research, the leading authority in medical device, dental and pharmaceutical market research, the U.S. market for urological devices is estimated to more than double in value by 2016, reaching over $5.4 billion.

6 Jan 2010

Lerner Medical Devices' Levia receives FDA clearance

Lerner Medical Devices, Inc. announced today that Levia®, a novel, in-home, ultraviolet B (UVB) phototherapy device, has received 510 (k) clearance from the U.S. Food and Drug Administration (FDA) for treatment of psoriasis and certain other skin conditions such as vitiligo.

6 Jan 2010

Bioheart signs distribution agreements to market Home Heart Failure Monitoring Systems in U.S.

Bioheart, Inc. announced today that the company has signed distribution agreements with Restoration Medical, McRay Medical, Alamo Scientific and Morey Medical. These distributors will assist Bioheart with introducing its Home Heart Failure Monitoring Systems to physicians and hospitals throughout the United States.

6 Jan 2010

IME introduces new drug-free pain relief alternative for headache

Innovative Medical Equipment, LLC. (IME) today announced the full U.S. market release of SOOTHEAWAY - a new, thermo-electrically heated and cooled therapy device that helps relieve migraine, tension or stress headache pain in the forehead, temples, occipital and ocular / sinus regions.

6 Jan 2010

Syneron Medical and Candela announce successful closing of their merger

Syneron Medical Ltd., an innovator in the development, marketing and sales of elos™ combined-energy medical aesthetic devices and Candela Corporation (NASDAQ: CLZR), a pioneer in the development of medical and aesthetic laser based technologies and systems, today announced the successful closing of their merger.

5 Jan 2010

MedApps receives CE Mark and CMDCAS certifications to distribute its products in Europe and Canada

MedApps, Inc., a leading Mobile Wireless Remote Patient Monitoring solution, announced today that it has successfully completed rigorous audits of its Quality Management System (QMS) and received ISO 13485:2003, ISO 9001:2008 and MDD from Underwriters Laboratories (UL), one of the most challenging auditing bodies in the world.

5 Jan 2010

Taoglas launches FLA.01 antenna

Taoglas, the leading M2M antenna provider, (www.taoglas.com) today announced that it has launched the first flexible circuit loop antenna, which can deliver over 40% efficiency in healthcare monitoring devices.

5 Jan 2010

WPI researchers lay groundwork for new generation of advanced prosthetic limbs

The conflicts in Iraq and Afghanistan have left a terrible legacy: more than 1,200 returning American soldiers have lost one or more limbs. To address this growing national need, researchers at Worcester Polytechnic Institute (WPI) are laying the groundwork for a new generation of advanced prosthetic limbs that will be fully integrated with the body and nervous system.

5 Jan 2010

Derma Sciences signs contract to produce finger bandages

Derma Sciences, Inc. (OTC Bulletin Board: DSCI), a specialty medical device/pharmaceutical company focused on advanced wound care, has finalized a contract with a leading global healthcare products company to produce finger bandages

5 Jan 2010

Thinidentity delivers 3,000th production license for its Clinical Virtual Desktop solution

ThinIdentity Corporation, a leader in improving clinician workflow in healthcare environments, today announced that it has delivered their 3,000th( ) production license since the official launch of the company on March 23, 2009. During the prior 9 months, 10 hospitals, ranging in size from 200 bed local hospitals to large multi-state systems with over 13,000 beds, have turned to ThinIdentity for its Clinical Virtual Desktop solution.

5 Jan 2010

Despite economic downturn, Russia still represents a promising healthcare market

Despite uncertain economic environment, Russia still represents a promising healthcare market with strong potential for further growth.

5 Jan 2010

Jamming bacterial communication may improve chronic wound care

Listening in on bacterial conversations could be the solution for improving chronic wound care, says a team of researchers at Binghamton University, State University of New York. Their findings have been published in the Journal of Applied Microbiology.

5 Jan 2010

Tactx Medical acquired by Creganna

Creganna, a leading supplier of technologies and services to medical device and lifesciences companies today announced that it has acquired Avalon Medical Services Pte Ltd. which trades as Tactx Medical Inc.

4 Jan 2010

Cepheid granted EUA for Xpert Flu A Panel test

Cepheid today announced it has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Xpert® Flu A Panel test.

4 Jan 2010

Cardima receives Shonin approval from the Japanese MHLW to market PATHFINDER catheters

Cardima, Inc., a medical device company focused on the diagnosis and treatment of atrial fibrillation (AF), has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to re-enter the Japanese market with its family of guidewire-based, multi-electrode PATHFINDER® diagnostic mapping catheters.

4 Jan 2010

Stryker acquires Ascent Healthcare Solutions

Stryker Corporation today announced the closing of its previously announced acquisition of Ascent Healthcare Solutions, the market leader in the reprocessing and remanufacturing of medical devices in the U.S.

From Stryker 3 Jan 2010

Anika Therapeutics acquires Fidia Farmaceutici subsidiary FAB

Anika Therapeutics, Inc. today announced that it has acquired Fidia Advanced Biopolymers, s.r.l. (“FAB”), a wholly-owned subsidiary of privately held Italian pharmaceutical company, Fidia Farmaceutici S.p.A. FAB provides hyaluronic acid-based (“HA”) products in several therapeutic areas including for the regeneration of connective and structural tissues damaged by injuries, aging or degenerative diseases.

3 Jan 2010

JumpStart announces two JumpStart Ventures investments

JumpStart Inc., the Northeast Ohio venture development organization that accelerates the progress of high growth early-stage businesses, announces two JumpStart Ventures investments.

31 Dec 2009

Spectranetics illegally imports unapproved medical devices, agrees to pay $5M for resolving allegations

Spectranetics Corporation, a medical device manufacturer, has agreed to pay the United States $4.9 million in civil damages plus a $100,000 forfeiture to resolve claims against the company, the Justice Department announced today. The claims arise from allegations that the company illegally imported unapproved medical devices and provided them to physicians for use in patients, conducted a clinical study in a manner that failed to comply with federal regulations and promoted certain products for procedures for which the company had not received Food and Drug Administration approval or clearance.

30 Dec 2009

Pre-market approval by FDA of cardiovascular devices often based on studies that lack adequate strength

Pre-market approval by the FDA of cardiovascular devices is often based on studies that lack adequate strength or may have been prone to bias, according to a study in the December 23/30 issue of JAMA. The researchers found that of nearly 80 high-risk devices, the majority received approval based on data from a single study.

29 Dec 2009