Regulatory: Page 267

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
Viatronix gets OK for virtual colonoscopy unit
By AuntMinnie.com staff writers
Three-dimensional-software developer Viatronix has received Food and Drug Administration 510(k) clearance for its V3D-Colon system.
April 25, 2004
U.S. Electronics gets clearance for new display
By AuntMinnie.com staff writers
Display distributor U.S. Electronics has received Food and Drug Administration 510(k) clearance for Totuku's CCL316 three-megapixel color LCD.
April 25, 2004
Cordis stent gets FDA panel recommendation
By AuntMinnie.com staff writers
Interventional technology developer Cordis has received an approval recommendation from the Circulatory System Devices Panel of the Food and Drug Administration for its Cordis Carotid System.
April 21, 2004
Quantum nets CE Mark
By AuntMinnie.com staff writers
Radiography vendor Quantum Medical Imaging has received the European Union's CE Mark for its product line.
April 21, 2004
EP MedSystems gets FDA clearance
By AuntMinnie.com staff writers
Electrophysiology device developer EP MedSystems of West Berlin, NJ, has received Food and Drug Administration clearance for its line of "deflectable" diagnostic catheters.
April 18, 2004
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