Precision diagnostics company Inoviq Ltd.’s stock soared 44% on the news that its breast cancer diagnostic, SubB2M/CA15-3, detected all stages of breast cancer with 87% accuracy, 81% sensitivity and 93% specificity. The clinical validation study that included 483 samples outperformed the standard of care CAS15-3 test, demonstrating an area under the curve (AUC) of .93 compared to .70.
The U.K. government created a new £21 million ($US26.55 million) fund to accelerate the roll out of artificial intelligence (AI) diagnostics and treatment tools across the NHS. The AI Diagnostic Fund will enable hospitals to bid for funding to speed up the deployment of the most promising AI imaging and decision support tools to help patients with cancers, strokes and heart conditions.
Gleamer SAS reported closing a series B round of $29.6 million to help expand its portfolio of artificial intelligence (AI) systems for radiologists and ramp international expansion. The exercise was led by Supernova Invest SAS who put up $11 million, joined by Heal Capital SAS with $5.5 million.
The recently concluded American Diabetes Association’s (ADA) 83rd Scientific Sessions continued to build powerful use cases for continuous glucose monitors in an ever-wider population and to highlight the value of automated insulin delivery (AID) systems that are getting ever-closer to duplicating the function of a natural pancreas. In addition to the news from Medtronic plc and Dexcom Inc. BioWorld covered earlier this week, Abbott Laboratories, Tandem Diabetes Care Inc. and Insulet Corp. also presented bright projections for future performance.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Invo Bioscience, Roche.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biodesix, Biosig, Cardinal Health, Cranius, Northstar Medical Radioisotopes, Nucleus Radiopharma, Owlet, Reified Labs, Thirona, Tivic.
The U.K. National Institute for Health and Care Excellence (NICE) has undertaken a public consultation for a series of proposed changes to its procedures for evaluating medical devices and other medical technologies that could speed up these reviews. This new process would require a less time-consuming approach to evaluating lower-risk technologies that would not only turn around such evaluations more rapidly but would also leave more resources available for higher-risk products that would also enjoy a timelier review, thus potentially accelerating adoption of all these products in the National Health System.