The FDA granted de novo marketing authorization for Paige Prostate, artificial intelligence (AI)-driven software that improves detection of prostate cancer. The clinical study submitted to the FDA demonstrated that using Paige Prostate resulted in a 7% improvement in sensitivity in correctly diagnosing cancer, increasing from 89.5% to 96.8%. Read More
The U.K. government has doubled down on its overarching strategy for artificial intelligence (AI) with a 10-year plan to sustain the nation’s place in the global AI race. One of the key considerations in this plan is to revisit the criteria for status as an inventor, a clear nod to the dilemma presented by proponents of allowing the DABUS algorithm to be named as an inventor. Read More
While European health care systems have historically lagged the U.S. in terms of digital adoption, a report by investment firm Albion VC is highlighting how the pandemic has created the momentum for change. Read More
LONDON – A pan European research project is working with manufacturers and clinicians to set measurement standards that will transform magnetic resonance images from 2D and pictorial, to 3D and quantitative, significantly increasing their diagnostic power. The project, led by the U.K. metrology body, the National Physical Laboratory (NPL), aims to introduce consistency and specificity for diagnosing specific conditions, by setting independently verifiable ways of noninvasively measuring lesions and the composition of different tissues and organs. Read More
The U.K. National Institute of Health and Care Excellence (NICE) has examined the evidence for the use of mitral valve-in-valve procedures and found the evidence for safety is well rounded despite concerns about several complications. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cardiac Insight, Galileo Research, Helaplex, Indygeneus AI, Insilicotrials Technologies, Inspira Technologies, Iterative Scopes, Know Labs, Lovell Government Services, Nephrosant, Pathai. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Co-Diagnostics, Ivwatch, Kleiner, Welldoc. Read More
