LEESBURG, Va.--(BUSINESS WIRE)--Mar 27, 2013--K2M, Inc., the largest privately held spinal device company in the world focused on developing innovative solutions for the treatment of complex spinal pathologies and minimally invasive procedures, today announced a major expansion of the company’s...
Ramco Innovations today announced the introduction of the Optex FA CD22 series of laser measurement sensors, a completely new line of sensors billed as the world’s smallest high accuracy laser measurement sensors with built in display currently on the market.
Miyachi Unitek’s products for the medical device industry include laser and resistance welding equipment, as well as fiber laser cutting, laser marking, and surface treatment technologies.
IBAG North America will feature the expanded “Micro Line” spindles at the MD&M EAST 2013 event in booth 2035. These compact and powerful high speed spindles for Swiss turning are offered as 20 and 22 mm to the 25 mm diameter models that operate up to 120,000 rpm.
Hamamatsu Photonics introduce the new C11208 MPPC module which integrates the S11028 series MPPC, a pixelated silicon avalanche photodiode operated in Geiger-mode, with the addition of a high performance thermoelectric cooler.
It's been a rocky road for pSivida's Illuvien, a drug/device combination for diabetic macular edema, but the company hopes that new trial data will pave the way to regulatory approval in the U.S. Watertown, Mass.-based pSivida, which licenses the Iluvien technology to Alimera Sciences, said the two companies plan to re-submit a new drug application to the FDA by the end of this month.
Students at the Lee Kong Chian School of Medicine will be the first in Southeast Asia to do virtual dissection on the latest Anatomage Table, which offers an interactive 3D experience.
ST. PAUL, Minn.--(BUSINESS WIRE)--Mar 27, 2013--Minnetronix, Inc., a medical device design, manufacturing and IP innovation services firm, announced today that Phil Ankeny will join the company as Chief Financial Officer beginning April 1, 2013.
Early diagnosis is critical in treating Lyme disease. However, nearly one quarter of Lyme disease patients are initially misdiagnosed because currently available serological tests have poor sensitivity and specificity during the early stages of infection.
PHILADELPHIA — The members of the American Association for Cancer Research have elected Carlos L. Arteaga, M.D., as their president-elect for 2013-2014. Arteaga is a professor of medicine and cancer biology at Vanderbilt University School of Medicine where he holds the Donna S. Hall chair in breast cancer research. He also serves as associate director...
NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, is excited to announce their participation at the 2013 International Society for the Advancement of Spine Surgery (ISASS) Conference from Tuesday,...
BD (Becton, Dickinson and Company) (NYSE:BDX), a leading global medical technology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the first drug to be offered in the just-launched BD SimplistT ready-to-administer, line of prefilled generic injectables....
There may be "hundreds and hundreds" of patients with complaints against medical device giant Medtronic and a spinal surgeon accused of performing experimental surgeries without informed consent. It's the latest development in the dramatic saga of Medtronic's controversial Infuse bone morphogenetic protein.
SAN DIEGO , March 27, 2013 /- Trovagene, Inc. (NASDAQ: TROV), today announced the commercial availability of its urine-based HPV-HR (high-risk) assay, a molecular human papillomavirus (HPV) test. The non-invasive test is designed to accurately identify the presence or absence of 15 known high-risk HPV strains using proprietary DNA sequences.
Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferiMarch 27, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments
FDA is issuing this guidance to provide industry and agency staff with recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices (IVDs) intended for the detection of antibodies to Borrelia burgdorferi.