Regulatory: Page 297

CTI adds new sales VP
By AuntMinnie.com staff writers
Computerized Thermal Imaging has appointed Michael Giallongo to the newly created position of vice president, eastern U.S. regional sales operations.
February 28, 2001
Imaging Diagnostic completes clinical studies
By AuntMinnie.com staff writers
Laser imaging developer Imaging Diagnostic Systems has completed the patient data collection segment of its clinical trials, according to the firm.
February 26, 2001
Magna-Lab files for FDA clearance
By AuntMinnie.com staff writers
February 26, 2001
PACS Roundtable, Part III: PACS executives weigh impact of IHE, new imaging modalities
By Erik L. Ridley
In today's final installment of our three-part PACS roundtable, several PACS industry leaders discuss the market effects of RSNA's and HIMSS’ Integrating the Healthcare Enterprise (IHE) initiative. They describe how advances in imaging modalities might affect the growth of digital image management. And they wrap it all up with a look at the future, offering predictions on what paths the PACS market will take in the months and years to come.
February 20, 2001
Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA
Issued February 16, 2001
This document is intended to provide guidance to industry on the type of information needed by the Center for Devices and Radiological Health (CDRH) to evaluate a marketing application for a full-field digital mammographic (FFDM) system. It supersedes Information for Manufacturers Seeking Marketing Clearance of Digital Mammography Systems: Status Update, issued February 4, 1999.
February 15, 2001
PEM gets FDA nod for breast imaging device
By AuntMinnie.com staff writers
Molecular imaging developer PEM Technologies has received Food and Drug Administration 510(k) clearance for a device that applies compression during scintigraphic breast imaging. The device is intended to support, position, and immobilize the breast during imaging examinations with injectable agents, according to the Bethesda, MD-based manufacturer.
February 13, 2001
ADAC gets FDA nod for IMRT software
By AuntMinnie.com staff writers
Nuclear medicine and radiation therapy firm has received Food and Drug Administration 510(k) clearance for its P3IMRT intensity modulated radiation therapy (IMRT) inverse planning software.
February 11, 2001
HHS updates HIPAA regulatory plans
By AuntMinnie.com staff writers
The change in presidential administrations hasn't swayed the U.S. Department of Health and Human Services from its plan to publish several final or proposed rules this year for the Health Insurance Portability and Accountability Act, according to the agency's senior health information policy advisor, Dr. Bill Braithwaite.
February 8, 2001
FDA greenlights Vital Images’ calcium scoring system
By AuntMinnie.com staff writers
Vital Images of Minneapolis has received 510(k) clearance from the Food and Drug Administration for VScore with AutoGate, a software system for coronary artery calcium scoring.
February 5, 2001
Surgi-Vision to market MR vascular guidewire
By AuntMinnie.com staff writers
Surgi-Vision of Columbia, MD has received the Food and Drug Administration's 501(k) clearance for the Intercept-Vascular guidewire, an MRI coil that can be threaded into a patient’s artery or vein in order to detect early signs of vascular disease.
February 5, 2001
Public meeting of FDA Radiological Devices Panel
Issued February 5, 2001
 The U.S. Food and Drug Administration's Center for Devices and Radiological Health will hold a public advisory committee meeting of the Radiological Devices Panel on March 5, 2001 from 9:00 a.m. to 3:30 p.m. in Rockville, MD.
February 4, 2001
Philips, Agilent deal hits U.S. snag
By AuntMinnie.com staff writers
Royal Philips Electronics’ pending acquisition of Agilent Technologies’ Healthcare Solutions Group of Palo Alto, CA, has hit another regulatory bump.
February 1, 2001
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