Medical Devices News and Research

RSS

Medical Brands' cranberry-based oral capsule granted Class IIa medical device status

Medical Brands has obtained a Class IIa medical device status through the appropriate Competent Authorities for Cranberry-Active, a patented cranberry-based oral capsule clinically shown to support urinary tract health.

2 May 2012

FDA permits Percutaneous Surgical Set for minimally invasive laparoscopic abdominal surgery

On April 30, the U.S. Food and Drug Administration today allowed marketing of the first surgical instrument set that can be assembled and disassembled inside the body during surgery.

2 May 2012

Array BioPharma third quarter revenue increases to $19.1M

Array BioPharma Inc. today reported financial results for the third quarter of fiscal 2012.

2 May 2012

DJOFL first quarter net sales increase 11.7% to $278.9 million

DJO Global, Inc., a leading global provider of medical device solutions for musculoskeletal health, vascular health and pain management, today announced financial results for its operating subsidiary, DJO Finance LLC, for the first quarter ended March 31, 2012.

2 May 2012

Teleflex to acquire all assets of Axiom Technology Partners

Teleflex Incorporated, a leading global provider of medical devices for critical care and surgery, today announced it has entered into a definitive agreement to acquire substantially all of the assets of Axiom Technology Partners, LLC, which makes the EFx family of laparoscopic fascial closure system products.

2 May 2012

Vessix V2 Renal Denervation System for hypertension receives CE Mark approval

Vessix Vascular, Inc., a developer of novel percutaneous radiofrequency (RF) balloon catheter technology for the treatment of hypertension, announced today that it has received Conformite Europeenne (CE) Mark approval for its V2 Renal Denervation System for the treatment of hypertension.

2 May 2012

Covidien acquires Newport Medical

Covidien plc, a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, today announced that it has completed the previously announced acquisition of Newport Medical Instruments, Inc. for an aggregate consideration of approximately $108 million, net of cash and short-term investments acquired.

2 May 2012

FDA clears Great Basin’s first C. diff molecular diagnostic test

Great Basin Corporation, a privately-held life sciences company developing sample-to-result molecular diagnostic solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for its first molecular diagnostic test for Clostridium difficile.

2 May 2012

Covidien acquires PolyTouch Medical

PolyTouch Medical Ltd., a leading developer of hernia mesh placement technologies, was acquired by Covidien, a leading global provider of healthcare products that is traded on the New York Stock Exchange at a current market value of $26 billion.

30 Apr 2012

Kauffman Foundation sponsors National Conference on Value-driven Engineering

Researchers, health care engineers and medical device experts gathered this week for the inaugural National Conference on Value-driven Engineering to Improve Medical Innovation for U.S. Global Competitiveness assembled by the Austen BioInnovation Institute in Akron (ABIA) and sponsored by the Ewing Marion Kauffman Foundation.

30 Apr 2012

McKesson to settle Medicaid billing lawsuit

The Justice Department says the prescription drug distributor overcharged Medicaid.

27 Apr 2012

First Edition: April 27, 2012

Today's headlines include details of a new study finding that, as a result of the health law, consumers and businesses will receive an estimated $1.3 billion in rebates from insurance companies this year.

27 Apr 2012

Asahi Kasei acquires ZOLL

Asahi Kasei Corporation, Japan's leading diversified chemical manufacturer with businesses in the health care, chemicals & fibers, homes & construction materials, and electronics sectors, announced today the successful completion of its acquisition of ZOLL Medical Corporation, a major US manufacturer of medical devices for critical care, on April 26, 2012, US Eastern time.

27 Apr 2012

Researchers develop small endoscopic device fitted with femtosecond laser scalpel

Whether surgeons slice with a traditional scalpel or cut away with a surgical laser, most medical operations end up removing some healthy tissue, along with the bad. This means that for delicate areas like the brain, throat, and digestive tract, physicians and patients have to balance the benefits of treatment against possible collateral damage.

24 Apr 2012

New report presents FDA's focus on global cooperation for product safety

The U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D. today released the agency's "Global Engagement Report," detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency. The report describes the steps the agency is taking to ensure that imported food, drugs, medical devices, and other regulated products meet the same rigorous standards for safety and quality as those manufactured domestically.

24 Apr 2012

FDA issues draft guidelines on approval process for use of nanoparticles in food and cosmetics

The United States Food and Drugs Administraton (FDA) has proposed that food companies that want to use tiny engineered particles called nanoparticles in their packaging may have to provide extra testing data to show the products are safe.

23 Apr 2012

Nephros granted rights to market products based on Medica's Medisulfone ultrafiltration technology

Nephros, Inc., a medical device company developing and marketing filtration products for therapeutic applications, infection control, and advanced water purification solutions, today announced that the company has entered into a strategic license and supply agreement with Medica S.p.A.

23 Apr 2012

Dehaier to distribute Timesco's laryngoscope Optima series of products in mainland China

Dehaier Medical Systems Ltd., an emerging leader in the development, assembly, marketing and sale of medical devices and homecare medical products in China, today announced that it has signed a strategic cooperation agreement with Timesco of London Ltd., one of the most progressive surgical and medical companies in the U.K.

23 Apr 2012

FDA clears Smiths Medical's ViaValve Safety I.V. Catheter

Smiths Medical, a leading global medical device manufacturer, today announced that its ViaValve Safety I.V. Catheter has been cleared by the U.S. Food and Drug Administration (FDA) and can be marketed in the United States.

23 Apr 2012

Enrollment complete for In-tunnel SeptRx European PFO Trial in Europe

SeptRx, an emerging medical device company that has developed the SeptRx Intrapocket PFO Occluder (IPO), reported today that it has completed enrollment for its "InterSEPT" (In-tunnel SeptRx European PFO Trial) clinical trial in Europe, and has entered into a partnership with CoRRect Medical GmbH for commercial distribution in Germany and Switzerland of the SeptRx IPO.

23 Apr 2012