By Jeff Shuren, M.D., J.D., Director of FDA's Center for Devices and Radiological Health.
Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval ApplicationsJune 24, 2010 6:32 am | by U.S. Food & Drug Administration | News | Comments
This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Federal Register: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of MeetingJune 24, 2010 6:31 am | by U.S. Food & Drug Administration | News | Comments
On August 26, 2010, the committee will discuss, make recommendations, and vote on premarket approval application for MelaFind, sponsored by MELA Sciences, Inc. MelaFind is a non-invasive computer vision system intended to assist in the evaluation of...
The ability to communicate is an elementary part of our lives, and without good hearing, communication becomes difficult if not impossible. This is why researchers continue to work on optimizing prostheses that improve hearing. Now researchers at the Universität Stuttgart in Germany have opened up a new avenue of
(American Thoracic Society) Exposure to high levels of fungus may increase the risk of severe asthma attacks among people with certain chitinase gene variants, according to a study from Harvard Medical School, Harvard Pilgrim Health Care Institute and Brigham and Women's Hospital.
Mersana Therapeutics Inc. has begun a Phase 1 trial of its anti-cancer drug candidate, designed to assess its safety and absorption in the body for patients with advanced solid tumors.
There are big savings in time and money for biotechs and pharmaceutical companies that turn to cloud computing, but it may only be for a while, not necessarily for the long term.
Medical device titan Boston Scientific Corp. has pulled together two deals worth $3 billion combined in loans and credit to replace its existing $1.75 billion revolving credit facility and pay some upcoming notes.
Besides losing weight, receiving cortisone shots, taking pain pills, or getting a total knee replacement, few options exist for patients living with moderate to severe osteoarthritis.
(Wiley-Blackwell) A new study of 1,960 white Americans and 368 black Americans with objectively diagnosed venous thromboembolism showed that, compared to whites, blacks had a significantly higher proportion with pulmonary embolism, including idiopathic PE among black women, and a...
It's hard to talk to someone who knows MIT inventor, scientist, professor, humanitarian and entrepreneur Bob Langer without bumping into superlatives. Langer's resume parallels that of the biotechnology industry itself.
Biotech CEOs can learn from each other, but when Aura Biosciences founder and CEO Elisabet de los Pinos sought advice from On-Q-ity CEO Mara Aspinall, it turned out that they had plenty in common with their philosophies and goals.
DNA analysis technology firm febit Inc. has announced plans to cut its workforce by about 60 percent. The company, which has locations in Lexington and Germany, has a staff of 90 to 100, according to a febit press contact, which would mean up to 60 positions would be sliced from the workforce.
Dialysis products maker NxStage Medical Inc. said Wednesday its Medisystems division has been awarded an exclusive five-year blood tubing supply contract with Atlantic Dialysis Management Services.Terms of the contract were not disclosed.Under the deal, Atlantic Dialysis will now use...