Medical Devices News and Research

RSS

Health Canada grants medical device licence to Gen-Probe's PANTHER system

Gen-Probe Incorporated announced today that Health Canada has granted the Company a medical device license for the PANTHER system, a fully automated and integrated molecular testing system designed with the flexibility to handle a wide range of testing needs.

23 Aug 2011

Vention Medical announces acquisition of Ansamed

Vention Medical, a leading full-service medical device outsourcing company, announced today its acquisition of Ansamed, Ireland's premier provider of advanced medical tubing solutions, including multilayer, co-extrusion and multi-lumen extrusion capabilities, and catheter design, development and manufacturing services.

23 Aug 2011

Online health records, medical devices face IT security risks

Meanwhile, iWatch News reports on how the health information sector seems especially fond of lobbying's "revolving door."

22 Aug 2011

Drug co. executive gives pharma a sunny forecast

Severin Schwan thinks the skeptics are wrong. Those who shun the pharmaceutical sector for its lack of prospects don't understand the potential created by a rapidly growing understanding of genetics and molecular biology, and the new drugs that will follow. ... the chief executive of Roche Holding AG, the world's seventh-largest drug firm by sales, is an informed optimist.

22 Aug 2011

Nightingale receives ISO 13485:2003 certification for EMR and associated services

Nightingale Informatix Corporation, a developer and provider of web-hosted Electronic Medical Record (EMR) software and associated services, announced today that it has received ISO 13485:2003 certification.

22 Aug 2011

UHC report outlines ways to combat high cost of care through supply chain purchasing process

While health care reform looks at ways to combat the high cost of care, many of the nation's top hospitals have already found ways to eliminate unnecessary costs through the supply chain purchasing process.

20 Aug 2011

Researchers demonstrate a way to control excitation and contraction in cardiac muscle cells

By employing optogenetics, a new field that uses genetically altered cells to respond to light, and a tandem unit cell (TCU) strategy, researchers at Stony Brook University have demonstrated a way to control cell excitation and contraction in cardiac muscle cells, the details of which are published in the early online edition of Circulation: Arrhythmia & Electrophysiology: "Stimulating Cardiac Muscle by Light: Cardiac Optogenetics by Cell Delivery."

19 Aug 2011

Kensey Nash fourth quarter total revenues decrease 14% to $18.7 million

Kensey Nash Corporation, a medical device company primarily focused on regenerative medicine for a wide range of medical procedures, today reported the results for its fourth quarter and fiscal year ended June 30, 2011.

18 Aug 2011

ACS honors MIT professor with Priestley Medal for controlled-release drug discovery

Robert S. Langer, Sc.D., the David H. Koch Institute Professor at Massachusetts Institute of Technology, has been named winner of the 2012 Priestley Medal by the American Chemical Society.

18 Aug 2011

Health Canada grants medical device license to Gen-Probe's PROGENSA PCA3 assay

Gen-Probe announced today that Health Canada has granted the Company a medical device license for the PROGENSA(R) PCA3 assay, a new molecular urine test that helps determine the need for repeat biopsies in men suspected of having prostate cancer.

17 Aug 2011

Neovasc completes previously announced non-brokered private placement

Neovasc Inc. today announced that it has completed a previously announced non-brokered private placement of 4,720,500 equity units at the price of $1.00 per unit for aggregate gross proceeds of approximately $4,720,500.

17 Aug 2011

Registration now open for California Healthcare Institute's 2011 Annual Meeting

CHI-California Healthcare Institute announced today that registration is now open for CHI's 2011 Annual Meeting. CHI's Annual Meeting focuses on the relationship between biomedical innovation and public policy. This year's theme is Shifting Sands: Forces Reshaping the Biomedical Innovation Business Model.

17 Aug 2011

FDA provides draft guidance focusing on PMAs

For the first time, the U.S. Food and Drug Administration has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices.

16 Aug 2011

FDA clears Resonance Health's MRI-Q System for cardiac T2* iron assessment

Resonance Health Ltd, a medical device company specializing in imaging core laboratory services has received FDA clearance to market its MRI-Q System.

16 Aug 2011

DJOFL second quarter net sales increase 14.5% to $277.8 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 second quarter of fiscal 2011, ended July 2, 2011.

16 Aug 2011

Misonix adds MD Solutions to distribution network in Asia and the South Pacific

Misonix, Inc., a medical device company that designs, manufactures and markets innovative therapeutic ultrasonic products worldwide has entered into a new three-year exclusive distribution agreement with MD Solutions Australasia Pty. Ltd., based in Newport, Victoria, Australia.

12 Aug 2011

PLC Systems second quarter total revenues increase to $398,000

PLC Systems Inc., a company focused on innovative medical device technologies, today reported financial results for the three- and six month periods ended June 30, 2011. These results only include the company's RenalGuard® operations, since PLC completed the sale of its transmyocardial revascularization (TMR) business to Novadaq Corp. during the first quarter of 2011.

12 Aug 2011

Nephros submits new 510(k) application with FDA for clearance of hemodiafiltration system

Nephros, Inc., a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification, today announced that on August 11, 2011 it filed a 510(k) application with the Food and Drug Administration (FDA) for clearance of its hemodiafiltration system.

12 Aug 2011

Viewpoints: WSJ on 'super committee'; NEJM perspectives on medical devices

At bottom, the recent deal was meant to defer the bedrock choices that need another election or two to resolve while making incremental progress. So the current exercise is about rooting out $1.5 trillion in "savings," which will mean a hodgepodge of changes at the margin, not a rewrite of either entitlements or taxes. If bigger change were possible, Speaker John Boehner and President Obama would have agreed to it.

12 Aug 2011

Global endoscopy equipment market to reach $33.7 billion by 2016: New report

By 2016 it is believed that the global endoscopy equipment market will be worth in excess of $33.7 billion, growing at a CAGR of 6.4% over the reporting period, according to a new report available on companiesandmarkets.com.

10 Aug 2011