Regulatory: Page 292

Agfa gets clearance for Drystar 4500
By AuntMinnie.com staff writers
Agfa has received Food and Drug Administration 510(k) clearance for its Drystar 4500 dry imaging system.
July 25, 2001
FDA's proposed 'globally harmonized' PMA alternative
Updated July 25, 2001
This draft guidance document describes the Food and Drug Administration's proposed pilot program to evaluate a globally harmonized alternative for premarket procedures.
July 24, 2001
Guidant releases self-expanding stent
By AuntMinnie.com staff writers
Interventional firm Guidant has launched a new self-expanding stent system for noncoronary anatomy.
July 24, 2001
12th Panama patient dies as investigation nears completion
By AuntMinnie.com staff writers
The 12th patient exposed to radiation overdose during treatment for pelvic cancer in Panama has died, Panamanian daily La Prensa reported yesterday.
July 24, 2001
Varian releases VariSeed 7.0 software
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems has released a new version of its VariSeed brachytherapy treatment planning software.
July 23, 2001
FDA provides details on Panama incidents
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has provided additional details regarding radiation overdoses received by cancer patients at Panama's National Institute of Oncology between August 2000 and February 2001.
July 22, 2001
Fischer’s SenoScan closes in on FDA PMA approval
By AuntMinnie.com staff writers
Denver x-ray and mammography developer Fischer Imaging received an approvable letter from the FDA on its premarket approval (PMA) application for the SenoScan digital mammography system.
July 22, 2001
HHS pushes 'reasonableness' in HIPAA guidance document
By Eric Barnes
Fear and loathing have surrounded the HIPAA privacy rule from the start, as U.S. doctors wondered how they'd ever care for patients under its strict requirements. But a new guidance document from the Department of Health and Human Services puts a more human face on patient privacy.
July 18, 2001
Deus gets clearance for lung-cancer CAD
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has granted premarket approval (PMA) to Deus Technologies of Rockville, MD, for its RapidScreen RS-2000 computer-aided diagnosis system for lung cancer screening.
July 12, 2001
Microboards gets approval for medical use of CD-R media
By AuntMinnie.com staff writers
CD and DVD provider Microboards Technology has received Food and Drug Administration clearance to market its CD-Recordable media for medical use.
July 1, 2001
Is healthcare today's most stable growth industry?
The healthcare industry has become one of the most promising sectors for investors, thanks to a combination of demographics, new technology, and the healthcare industry's financial reimbursement structure. By Michael O'Hanlon.
June 20, 2001
U.S. approves PET for re-staging breast cancer
By AuntMinnie.com staff writers
Despite previous rumblings that Medicare payment for imaging breast cancer with PET cancer was a no-go, an advisory committee to the Centers for Medicare and Medicaid Services voted Tuesday to accept recurrent breast cancer as an indication for the use of PET.
June 19, 2001
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