Regulatory: Page 266

SCAI says CMS should boost stent payments
By AuntMinnie.com staff writers
A new task force report from the Society for Cardiovascular Angiography and Interventions says current payment levels from the Centers for Medicare and Medicaid Services (CMS) for drug-eluting stent procedures are inadequate.
May 20, 2004
Agfa RIS gets OK from German payors
By AuntMinnie.com staff writers
The Agfa Healthcare RIS system has been certified by the German National Association of Statutory Health Insurance Physicians.
May 20, 2004
Cedara gets 510(k) for I-ReadMammo
By AuntMinnie.com staff writers
Cedara Software has received Food and Drug Administration 510(k) marketing clearance for I-ReadMammo, a new mammography reading workstation for diagnosis and screening.
May 18, 2004
Demetech brings Calscan to U.S.
By AuntMinnie.com staff writers
Swedish bone densitometry developer Demetech has received Food and Drug Administration clearance for its DXL Calscan bone densitometer.
May 17, 2004
Sectra gets clearance for 3D
By AuntMinnie.com staff writers
Swedish PACS firm Sectra has received Food and Drug Administration clearance for its 3D visualization package.
May 13, 2004
Two new patents for Omnisonics
By AuntMinnie.com staff writers
Vascular ultrasound developer OmniSonics Medical Technologies of Wilmington, MA, has been granted two U.S. patents covering its OmniWave technology platform. The patent enables the deployment of the devices in a clinical setting, according to the company.
May 12, 2004
Braintree gets FDA OK for HalfLytely
By AuntMinnie.com staff writers
Pharmaceutical developer Braintree Laboratories of Braintree, MA, has received Food and Drug Administration approval for its HalfLytely and Bisacodyl Tablets Bowel Prep as a prescription preparation for bowel cleansing prior to colonoscopy.
May 12, 2004
Prowess gets 510(k) clearance
By AuntMinnie.com staff writers
Radiation treatment-planning software developer Prowess of Chico, CA, has received 510(k) clearance from the Food and Drug Administration for its Prowess Panther direct-aperture optimization-based intensity-modulated radiation therapy (IMRT) planning system.
May 10, 2004
CPT codes and the politics of virtual colonoscopy
By Eric Barnes
It is a bumpy ride, to be sure, but virtual colonoscopy is making steady progress toward the Holy Grail of any new medical test in the U.S.: Medicare reimbursement. The issuance of temporary CPT codes for virtual colonoscopy earlier this year is a major step forward on a political path that has been as tortuous as any colon.
April 29, 2004
Varian receives 510(k) for brachytherapy afterloader
By AuntMinnie.com staff writers
Radiation oncology firm Varian Medical Systems of Palo Alto, CA, has received 510(k) marketing clearance from the Food and Drug Administration for a new single-channel device for delivering high-dose-rate (HDR) brachytherapy.
April 26, 2004
ISMP issues MRI safety alert for transdermal patches
By AuntMinnie.com staff writers
Medication patches containing aluminized backings could potentially cause injury if not removed before an MRI procedure.
April 26, 2004
Thermal firm CTI gets Canadian OK
By AuntMinnie.com staff writers
Thermal breast imaging developer Computerized Thermal Imaging has received a medical device license from Health Canada to market its breast cancer imaging system (BCS2100) in that country.
April 26, 2004
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