Regulatory: Page 288

U.S. Senate delays HIPAA transaction and code set standards
By AuntMinnie.com staff writers
Last week the U.S. Senate approved a bill (S. 1684) that would postpone until October 2003 the compliance deadline for the Health Insurance Portability and Accountability Act's transactions and code sets rules.
December 4, 2001
CADx gets approvable letter for Second Look system
By Brian Casey
CHICAGO - The mammography market could soon see a new competitor in the computer-aided detection (CAD) niche. Canadian developer CADx Medical Systems this week received an approvable letter from the FDA for its Second Look CAD system. Once final premarket approval (PMA) is received, CADx will join R2 Technology as one of two companies able to market a CAD system in the U.S.
November 27, 2001
Draxis gets NRC approval for BrachySeed Pd-103
By AuntMinnie.com staff writers
Radiopharmaceutical manufacturer DraxImage has received final approval from the U.S. Nuclear Regulatory Commission for the palladium version of its BrachySeed brachytherapy implant.
November 12, 2001
Final PMA approvals for October 2001
Issued November 7, 2001
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of premarket approvals (PMA), product development protocols (PDP), supplement and notice decisions from the previous month. The following decisions were rendered for October 2001.
November 6, 2001
FDA offers guidance on lowering CT dose
By Eric Barnes
The U.S. Food and Drug administration has issued a notification emphasizing the importance of keeping radiation dose during CT procedures as low as reasonably achievable, "especially for pediatric and small adult patients, who may sometimes receive more radiation than needed to obtain diagnostic images," the agency said.
November 5, 2001
Colorado MedTech posts Q1 loss
By AuntMinnie.com staff writers
Medical imaging outsourcing firm Colorado MedTech reported a first-quarter loss as the Boulder-based firm continued to face fallout from a since-resolved FDA warning letter.
November 5, 2001
Final 510(k) approvals for October 2001
Issued November 5, 2001
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of devices approved for marketing in the U.S. during the previous month. The following is a list of 510(k) final decisions rendered for October 2001.
November 4, 2001
GE Medical Systems introduces real-time bone imaging
By AuntMinnie.com staff writers
The Food and Drug Administration has cleared a bone ultrasonometer with real-time imaging by GE Medical Systems of Waukesha, WI.
November 1, 2001
Hologic gets 510(k) for entry-level mammography system
By AuntMinnie.com staff writers
While it awaits FDA premarket approval for its full-field digital mammography system, Hologic of Bedford, MA, has received 510(k) clearance of an entry-level film-screen product, Lorad Affinity.
October 31, 2001
Final PMA approvals for September 2001
Issued October 26, 2001
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of premarket approvals (PMA), product development protocols (PDP), supplement and notice decisions from the previous month. The following decisions were rendered for September 2001:
October 25, 2001
Hologic gets FFDM approvable letter
By AuntMinnie.com staff writers
Hologic's Lorad division has received an approvable letter from the U.S. Food and Drug Administration for its Full-Field Digital Mammography system.
October 25, 2001
Odin gets CE Mark for PoleStar
By AuntMinnie.com staff writers
Odin Medical Technologies has received the European Community's CE Mark for its PoleStar N-10 MR image guidance system.
October 17, 2001
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