Regulatory: Page 293

CTI secures CE Mark
By AuntMinnie.com staff writers
Computerized Thermal Imaging has received regulatory approval to apply the CE Mark to its Breast Cancer System 2100.
June 19, 2001
Guidant gets clearance for biliary stent
By AuntMinnie.com staff writers
Interventional firm Guidant has received Food and Drug Administration clearance for its OmniLink .035 biliary stent system.
June 19, 2001
Dynamic to perform reverse stock split
By AuntMinnie.com staff writers
Healthcare information technology firm Dynamic Healthcare Technologies will be implementing a one-for-three reverse split of its common stock.
June 19, 2001
CTI submits final module of PMA application
By AuntMinnie.com staff writers
Thermal imaging developer Computerized Thermal Imaging has submitted the fifth and final module of its premarket approval (PMA) application to the Food and Drug Administration for its Breast Cancer System 2100.
June 17, 2001
FDA approves R2 CAD for use with diagnostic mammograms
By AuntMinnie.com staff writers
Computer-aided detection developer R2 Technology of Los Altos, CA, has received Food and Drug Administration clearance to expand the indications for its ImageChecker system to include diagnostic mammograms.
June 12, 2001
Magna-Lab gets approval for Cardiac View
By AuntMinnie.com staff writers
Cardiac MRI coil developer Magna-Lab has received Food and Drug Administration 510(k) clearance for its Cardiac View surface coil.
June 12, 2001
MDS Nordion gets OK for dose-calculation software
By AuntMinnie.com staff writers
Canadian radiation oncology firm MDS Nordion has received Food and Drug Administration 510(k) clearance for Dose Modelling, an independent dose-calculation software program for inverse planning of intensity-modulated radiation therapy.
June 11, 2001
FDA approves Nycomed Amersham's EchoSeed
By AuntMinnie.com staff writers
Nycomed Amersham Imaging has received FDA clearance to market EchoSeed, a new brachytherapy product the company says will maximize patient care.
June 3, 2001
Investigation continues in fatal Panama radiation therapy accident
By Eric Barnes
Investigators in Panama are searching for the cause of a radiation therapy accident that killed one cancer patient and overradiated 27 others.
May 28, 2001
Fischer shuffles sales, service operations
By AuntMinnie.com staff writers
Mammography firm Fischer Imaging has reorganized its sales and service field operations in an effort to focus its energies on breast care.
May 23, 2001
FDA Mammography Quality Standards Act Final Regulations
Issued May 23, 2001
The Mammography Quality Standards Act Final Guidance for Industry and the FDA, document #4, is intended to provide guidance to mammography facilities and their personnel. It represents the Food and Drug Administration's (FDA) current thinking on implementing the Mammography Quality Standards Act (MQSA) (Pub. L. 102-539).
May 22, 2001
FDA's radiation concerns may lead to dose displays for scanners
By Robert Bruce
With radiation exposure becoming a public issue in the U.S., the Food and Drug Administration is developing regulations that will require dosage monitoring displays on all new imaging scanners that emit ionizing radiation.
May 21, 2001
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