FDA: Page 11

U-Systems lands funding
By AuntMinnie.com staff writers
Ultrasound developer U-Systems has finalized a $6.5 million financing round from existing investors and affiliates.
May 8, 2011
FDA approves Sectra full-field digital mammography unit
By Brian Casey
The U.S. Food and Drug Administration announced on Tuesday that it has approved a full-field digital mammography (FFDM) unit from Swedish mammography and PACS developer Sectra. The approval is the latest since the agency revised its rules in November 2010 on new FFDM approvals.
May 2, 2011
FDA asks IDSI for more info on CTLM 510(k)
By AuntMinnie.com staff writers
Imaging Diagnostic Systems (IDSI) has received notification from the U.S. Food and Drug Administration requesting more information for a 510(k) application it submitted for its CT laser mammography (CTLM) imaging device.
April 6, 2011
Covidien gets FDA nod for Pipeline
By AuntMinnie.com staff writers
Healthcare technology firm Covidien said that the U.S. Food and Drug Administration has approved the premarket approval application for its Pipeline embolization device.
April 6, 2011
Philips gets 510(k) for Ingenia MRI
By AuntMinnie.com staff writers
Philips Healthcare has received U.S. Food and Drug Administration 510(k) clearance for its Ingenia MRI system.
April 5, 2011
NeuroLogica gets 510(k) for BodyTom
By AuntMinnie.com staff writers
Portable scanner developer NeuroLogica has received U.S. Food and Drug Administration 510(k) clearance for its BodyTom CT scanner.
March 30, 2011
U-Systems touts US breast screening study
By AuntMinnie.com staff writers
The University of Chicago has completed a reader study to evaluate the somo.v automated breast ultrasound system from U-Systems for detecting breast cancer in women with dense breast tissue.
February 14, 2011
Medicare's imaging volume drops; digital x-ray shifts from CR to DR
By Brian Casey
February 9, 2011
FDA to launch new regulatory fast track for medical devices
By Kate Madden Yee
The U.S. Food and Drug Administration today announced a new priority review program for innovative medical devices. Products reviewed under the program could hit the market more quickly, with the FDA conducting reviews within 150 days -- nearly half the time it currently takes.
February 7, 2011
2011 02 08 14 41 28 731 Fda Logo Blue Thumb
FDA clears first app for image review on iPads, iPhones
By Erik L. Ridley
The U.S. Food and Drug Administration has issued 510(k) clearance of MIM Software's Mobile MIM application, the first mobile image viewing application to receive clearance for diagnostic use on Apple's iPhone and iPad devices.
February 3, 2011
FDA approves Carestream CR mammo software
By AuntMinnie.com staff writers
Carestream Health has received approval from the U.S. Food and Drug Administration for a premarket approval (PMA) supplement for advanced screens and image processing software for the company's computed radiography (CR) mammography system.
December 8, 2010
Imaging3 to resubmit 510(k) application
By AuntMinnie.com staff writers
3D imaging device developer Imaging3 announced it will resubmit an application to the U.S. Food and Drug Administration under the FDA's 510(k) process for its Dominion volumetric imaging scanner.
November 28, 2010
Previous Page
Page 11 of 32
Next Page