Regulatory: Page 246

Neurognostics nets FDA nod
By AuntMinnie.com staff writers
Functional MRI technology provider Neurognostics has received a Special 510(k) approval for its MindState fDAD offering.
October 26, 2005
GE gets FDA OK for Lunar iDXA
By AuntMinnie.com staff writers
Multimodality vendor GE Healthcare has received Food and Drug Administration clearance for its new bone mineral density measurement system, Lunar iDXA.
October 25, 2005
Cook gets CE Mark for Zenith
By AuntMinnie.com staff writers
Interventional technology developer Cook has received CE Mark certification for its Zenith Fenestrated AAA endovascular graft, according to the Bloomington, IN-based firm.
October 24, 2005
Double Black, WIDE get 510(k) for mammo LCD
By AuntMinnie.com staff writers
Monitor distributor Double Black Imaging said that its partner WIDE has received Food and Drug Administration 510(k) clearance for its IF2105M LCD system, opening the door for its use in digital mammography applications.
October 20, 2005
Elekta gets Japanese OK for Gamma Knife
By AuntMinnie.com staff writers
Swedish radiation therapy firm Elekta said that the Japanese Ministry for Health, Labour and Welfare has given approval of its Leksell Gamma Knife 4C for noninvasive intracranial radiosurgery.
October 19, 2005
Alliance gets OK for AcuNav reprocessing
By AuntMinnie.com staff writers
Single-use medical device reprocessor Alliance Medical of Phoenix has received Food and Drug Administration 510(k) clearance to reprocess AcuNav ultrasound catheters from Siemens Medical Solutions of Malvern, PA.
October 16, 2005
Elekta gets Canadian IGRT approval
By AuntMinnie.com staff writers
Swedish radiation therapy developer Elekta reported that its Synergy Platform and X-ray Volume Imaging products for image-guided radiation therapy (IGRT) have received approval from Health Canada for sale and use in the country.
October 12, 2005
ACR's breast imaging accreditation expands on MQSA
Mammography facilities have raised concerns about the American College of Radiology's (ACR) breast imaging accreditation questionnaire, such as how to answer questions that ask for information not required by the Mammography Quality Standards Act (MQSA). Priscilla Butler, senior director of the ACR's Breast Imaging Accreditation Programs, explains that some of these questions are for data collection purposes, but notes that facilities should not regard this information as unimportant.
October 10, 2005
2005 09 27 16 01 15 706
Medtronic submits PMA module for Endeavor
By AuntMinnie.com staff writers
Medical device developer Medtronic has submitted the first premarket approval application (PMA) module for its Endeavor drug-eluting coronary stent to the Food and Drug Administration.
October 9, 2005
AnthroCare gets 510(k) for bone cement
By AuntMinnie.com staff writers
Medical device developer AnthroCare of Austin, TX, has received 510(k) clearance from the Food and Drug Administration for a new bone cement designed to be used during vertebroplasty or kyphoplasty procedures.
October 9, 2005
SoftScan trial under way
By AuntMinnie.com staff writers
Optical molecular imaging developer ART Advanced Research Technologies said that a clinical study of its SoftScan breast imaging system has begun at Massachusetts General Hospital in Boston.
October 6, 2005
Guidant launches cobalt chromium stent in Japan
By AuntMinnie.com staff writers
Interventional device vendor Guidant of Indianapolis announced the launch of its Multi-Link Vision RX coronary stent system in Japan, following regulatory and reimbursement approvals.
October 6, 2005
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