FDA clears AccuImage's software products:
This article was originally published in Clinica
Executive Summary
AccuImage Diagnostics' has received US FDA 510(k) clearance to market its new line of AccuImage software products for medical image processing. The new software provides high-speed, two-dimensional and three-dimensional medical image processing, visualisation and transmission within the hospital and to the home via the Internet, said the San Francisco, California-based company. All software products are DICOM 3.0 compliant and can be run on standard Pentium-based PCs with Windows operating systems.
You may also be interested in...
Biden Administration Is Setting An Example For Safe AI Use In Federal Organizations
A new memorandum by the Director of the Office of Management and Budget initiated a government-wide policy that will appoint AI officers to all agencies to address risks for AI use and serve as an example for greater AI adoption.
US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation
CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach.
New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments
Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.