Public Meeting - Strengthening the National Medical Device Postmarket Surveillance System, September 10, 2012August 30, 2012 12:00 am | by U.S. Food & Drug Administration | News | Comments
The purpose of this meeting is to solicit public feedback regarding FDA?s proposal to strengthen the national medical device postmarket surveillance system.
Public Workshop - Leveraging Registries With Medical Device Data for Postmarket Surveillance and Evidence Appraisal Throughout the Total Product Life Cycle, September 12-13, 2012August 30, 2012 12:00 am | by U.S. Food & Drug Administration | News | Comments
The topic to be discussed is best practices for use of registries with medical device data for postmarket surveillance, clinical studies, and evidence appraisal.
Ariad Pharmaceuticals Inc. (Nasdaq: ARIA) of Cambridge has submitted its lead compound, ponatinib, which targets a rare form of leukemia, for approval in Europe.
On the heels of launching a nasal aerosol for allergies, Sunovion Pharmaceuticals said late Thursday that it will acquire Elevation Pharmaceuticals Inc., a private biopharma company that develops aerosol therapies for individuals with respiratory diseases.
Life sciences company EMD Millipore, a division of Merck KGaA of Germany, has donated $10,000 to charity: water, a nonprofit focused on bringing safe drinking water to people in developing nations.
Infertility treatment startup OvaScience Inc. has filed a registration statement with the U.S. Securities and Exchange Commission to go public on the Over The Counter Bulletin Board (OTCBB) or another informal exchange.
Woburn-based biotech company ArQule Inc. has learned that partner Kyowa Hakko Kirin Co., Ltd., which has exclusive development rights to ArQule’s lead product candidate tivantinib in Japan, has suspended patient enrollment in its ongoing Phase 3 trial dubbed ATTENTION.
Medical research equipment and services provider Charles River Laboratories International Inc. said Wednesday that it bought Accugenix, a company that creates testing used to identify microbes. Charles River Labs paid $17 million in cash for Accugenix, based in Newark, Del. It said Accugenix'...
IRVINE, Calif. and AMSTERDAM, Aug. 29, 2012 /- Agendia, an innovative molecular cancer diagnostics company and leader in personalized medicine, conducted one of its premiere thought leadership events, "Present and Future Trends in Breast Cancer Genomics," on Saturday, August 25, 2012. The event was held at The Westin Times Square Hotel in New York City and featured over 20...
No Edwards Lifesciences insiders have bought company stock since April 2012, during which time EW shares have gained nearly 40%. Edwards Lifesciences (NYSE:EW) insiders aren't buying, and they haven't been for several months, according to a report. Although insiders have been selling shares, 3 of them in the last week, none have purchased any since at least April, SeekingAlpha reported. News Well, Insider Trading, Wall Street Beatread more
Women with heart failure are less likely to receive treatment, more likely to survive TAVI and less and more prone to stroke than men, according to research presented at the 2012 European Society of Cardiology Congress. Men and women have similar in-hospital death rates, but women get less treatment News Well, Cardiac Rhythm Management, Cardiovascular, Drug-Eluting Stents, European Society of Cardiology Congress, Replacement Heart Valves, Women's Healthread more
LITTLE FALLS, N.J., Aug. 29, 2012 /- CANTEL MEDICAL CORP. (NYSE: CMN ) announced today that Andrew A. Krakauer, President & CEO, will be presenting at the CL King 10th Annual Best Ideas Conference at the Omni Berkshire Place Hotel in New York. The formal presentation is scheduled to begin at 9:20 AM EDT on Wednesday, September 12, 2012. In addition, Mr. Krakauer and Seth M. Ye...
BEDFORD, Mass., Aug. 29, 2012 /- Hologic, Inc. (NASDAQ: HOLX ) (Hologic) today announced that Rob Cascella, President and Chief Executive Officer, will present at the Morgan Stanley Global Healthcare Conference in New York City, New York on Tuesday, September 11, 2012 at 10:20 a.m. (Eastern Time). Interested parties are invited to listen to the live audio webcast of the i...
Rehab and physical therapy devices maker Hollywog lands FDA 510(k) clearances for its WiTouch and WiTouch Pro wireless pain management devices, the 1st such systems to use nerve stimulation technology to target back pain. Rehab and physical therapy devices startup Hollywog landed a pair of FDA nods for its wireless back pain therapy devices, the WiTouch and the WiTouch Pro. The devices use transcutaneous electrical nerve stimulation, a process in which electrical signals are transmitted through the skin to stimulate nerve or muscle fibers, to suppress pain signals before they they reach the brain and ramp up the body's production of pain-relieving endorphins, according to the company's website. News Well, 510(k), Neuromodulation / Neurostimulation, Pain Management, Rehabilitation Equipmentread more
Hologic gets a date with the FDA to explore expanded indication for its already-approved 3D digital mammography systems. Massachusetts-based women's health devices maker Hologic (NSDQ:HOLX) has got a date with the FDA. Later this year the federal watchdog agency's Radiological Devices Panel will meet in Washington D.C. to discuss expanding approval for Hologic's 1st-of-its-kind Selenia Dimensions 3D digital mammography system. News Well, Breast Cancer, Food & Drug Administration (FDA), Imaging, Mammography, Pre-Market Approval (PMA), Regulatory/Complianceread more