The artificial intelligence-first approach to drug discovery may be boosting productivity but has also exposed the fact that in silico design can only go so far. At some point it will be necessary to revert to the conventional method and synthesize a protein and do an experiment. Now newco Adaptyv Bio aims to smooth this transition by applying cell-free systems and micro fluidics to enable proteins to be synthesized and validated at nano scale.
Diabeloop SA reported a partnership with Novo Nordisk A/S. The med-tech is planning to integrate DBL-4pen, its self-learning algorithm for multiple daily injection therapy, into Novo Nordisk's connected, reusable insulin pens: Novopen and Novopen Echo Plus. “Our partnership is designed to deliver more automated solutions to people with diabetes, optimizing outcomes and improving quality of life,” Cecile Ferracci, CCO of from Grenoble, France-based Diabeloop, told BioWorld.
Developers of clinical decision support (CDS) software have their hands full with a recent U.S. FDA final guidance on these products, but the picture promises to become more byzantine with the publication of a draft rule by the Office of the National Coordinator (ONC). The new ONC proposal would require a demonstration of transparency for decision support intervention (DSI) predictive functions in order for that software to qualify for ONC certification, a requirement that might not overlap neatly with the FDA’s own transparency requirements.
Okwin Inc. is leading a consortium of hospitals and pathology labs from across France as part of a €33 million (US$36 million) project to develop and deploy new digital pathology artificial intelligence (AI) tools to improve cancer care. The project, called Portrait, is backed by the French government, and the hope is that by producing more efficient and accessible diagnostic tools, clinicians will be able to better tailor treatments to individual patients at an earlier stage of the disease.
Developers of artificial intelligence (AI) and machine learning (ML) algorithms have found themselves returning repeatedly to the U.S. FDA for seemingly modest updates to their products, a problem that may soon be relieved by an FDA draft guidance on predetermined change control for AI and ML. However, Brad Thompson of Epstein, Becker & Green, P.C., told BioWorld that the terms of the draft “hugely increases the burden on developers to plan ahead” in order to obtain that postmarket relief from repeated 510(k) filings, a concession that device manufacturers and software developers may be more than willing to make.
Medtronic plc has announced a plan by Cosmo Pharmaceuticals NV and Nvidia Inc. to integrate Nvidia's artificial intelligence (AI) technologies into Medtonic’s GI Genius intelligent endoscopy module. GI Genius is designed to host multiple AI algorithms as the first U.S. FDA-cleared, AI-assisted colonoscopy imaging tool for detecting polyps that can lead to colorectal cancer.
Brainomix Ltd. received U.S. FDA clearance for its Brainomix 360 E-aspects tool, a fully automated AI-imaging solution for stroke assessment. Powered by explainable AI, the Brainomix 360 E-aspects tool, which is already CE-marked, assesses non-contrast CT scans to automatically generate a score and measures the volume of ischemic signs. It also features an overlaid heatmap to visually assist clinicians when treating stroke patients.
Artificial intelligence (AI)-powered drug discovery startup Protai Bio Ltd. raised $12 million in additional seed funding, bringing the total amount to $20 million that will see the company build out an oncology drug discovery pipeline derived from its AI proteomics platform.
Artificial intelligence (AI)-powered drug discovery startup Protai Bio Ltd. raised $12 million in additional seed funding, bringing the total amount to $20 million that will see the company build out an oncology drug discovery pipeline derived from its AI proteomics platform.
Methinks Software SL (dba Methinks.AI), a digital health company, is working on the U.S. FDA submission for its artificial intelligence (AI)-based stroke triage software, which will aid in the detection of acute stroke, after recently receiving CE mark certification.
