R2's ImageChecker CAD Unanimously Endorsed By Radiology Panel
This article was originally published in The Gray Sheet
Executive Summary
R2 Technology's ImageChecker M1000 could identify and mark for further review 31-44% more potentially positive mammograms than would currently be identified, William Sacks, a medical officer in FDA's Office of Device Evaluation, said at a Radiological Devices Advisory Panel meeting in Rockville, Maryland.
You may also be interested in...
Fischer Taking Chance With SenoScan 510(k), Leaving PMA Route Open
Fischer Imaging's premarket notification submission for the SenoScan full-field digital mammography system is readily convertible into a PMA, should FDA reject the 510(k) approach for the device, as the agency has done in the past.
Takeda, Astellas Found New JV To Support Japanese Bioventures
Major Japanese companies Takeda, Astellas and SMBC are joining hands to establish a new joint venture with $3.9m capital and based in Japan’s largest biocluster Shonan iPark to help incubate local biopharma start-ups.