Regulatory: Page 294

Nucletron software receives 510(k) clearance
By AuntMinnie.com staff writers
Radiation-therapy vendor Nucletron received FDA clearance to market the newest iterations of its stereotactic planning software and multimodality image fusion software for radiation therapy planning.
May 21, 2001
Varian gets FDA OK for Eclipse software
By AuntMinnie.com staff writers
Varian Medical Systems has received U.S. Food and Drug Administration 510(k) clearance for its Eclipse treatment-planning system for radiotherapy.
May 15, 2001
FDA clears GE's 3-tesla body coil
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has issued 510(k) clearance to GE Medical Systems for a body coil designed for use with its 3-tesla Signa VH/I ultra-high-field MRI scanner.
May 10, 2001
NIH appoints Dean to direct NIBIB
U.S. National Institutes of Health (NIH) director Dr. Ruth Kirschstein has appointed Donna Dean, Ph.D., as acting director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB).
May 9, 2001
Hologic files PMA for Lorad digital mammography system
By Erik L. Ridley
Hologic has moved closer to its goal of commercializing a full-field digital mammography system. The Bedford, MA-based vendor has filed a premarket approval application with the Food and Drug Administration for its Lorad charge-coupled device (CCD)-based unit.
May 3, 2001
SCAR keynote speaker sees technology-driven future ahead for medicine
By Erik L. Ridley
SALT LAKE CITY - Healthcare in the new millennium will be characterized by a new era of high technology, according to Russell Coile, Jr., a healthcare futurist who delivered the keynote address at this week's SCAR meeting.
May 2, 2001
ACADRAD calls for more imaging institute funds
By AuntMinnie.com staff writers
The Academy of Radiology Research (ACADRAD) said yesterday that the amount of money budgeted to create a National Institute of Biomedical Imaging and Bioengineering (NIBIB) is inadequate.
May 1, 2001
FDA seizes Wuestec equipment over paperwork
By Robert Bruce
Digital x-ray vendor Wuestec is hoping to soon resolve a Food and Drug Administration enforcement action that led to the confiscation of equipment related to the firm's legacy conventional x-ray systems.
April 30, 2001
DraxImage files for approval for brachytherapy implant
By AuntMinnie.com staff writers
Radiopharmaceutical firm DraxImage has filed for clearance of its palladium-103 brachytherapy implant with the Food and Drug Administration and the Nuclear Regulatory Commission.
April 26, 2001
CAD startup Deus seeks clearance for lung-cancer device
By Kate Madden Yee
Computer-aided detection (CAD) technology may soon be deployed for lung cancer screening, if Maryland startup Deus Technologies has its way. The company has filed a PMA application for its RapidScreen RS-2000 lung cancer CAD unit.
April 19, 2001
ACNP and SNM fail to modify nuclear medicine regulations
By AuntMinnie.com staff writers
The U.S. Nuclear Regulatory Commission has denied a petition to modify its proposed regulation of diagnostic nuclear medicine.
April 17, 2001
Bard gets clearance for biliary stent
By AuntMinnie.com staff writers
Interventional firm has received Food and Drug Administration clearance to market its Memotherm endoscopic biliary stent for the treatment of malignant biliary obstructions.
April 16, 2001
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