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The Washington Legal Foundation (WLF) has called on the FDA to cease its efforts to impose device regulations on clinical laboratories that provide diagnostic tests developed and validated in-house to physicians.
It looks like Kyphon's six-year run of virtual freedom from competition in the spine bone fracture treatment market is coming to an end, Lazard Capital Markets analyst Alexander Arrow said Oct. 2.
Five Democratic lawmakers have asked HHS to give them an update on the agency's investigation into former FDA Commissioner Lester Crawford's "sudden" resignation from the FDA one year ago.
Providing an update on progress and new findings on his optical tests for the early detection of Alzheimer's disease, Lee Goldstein of Brigham and Women's Hospital and Harvard Medical School will describe dramatic new developments in the technology during a plenary talk at Frontiers in Optics, the annual meeting of the Optical Society of America (OSA) in Rochester, N.Y., which takes place next week.
Advanced Neuromodulation Systems (ANS), the neuromodulation business of St. Jude Medical, Inc., announced Australian Therapeutic Goods Administration (TGA) regulatory approval for its Eon Rechargeable Neurostimulation System.
A test can help doctors determine which lung cancer patients will respond to a leading chemotherapy drug and avoid ineffective treatments and side effects in those who don't, Spanish researchers said on Monday.
Spire Corporation announced that it has been awarded a $399,243, two-year grant from the National Institutes of Health-National Institute of Arthritis and Muskuloskeletal and Skin Diseases (NIH-NIAMS) to develop a new type of nanotechnology coating for wear-resistant orthopedic devices, with specific applications for spinal implants.