Rapidai Inc. received FDA 510(k) clearance for its Rapid NCCT Stroke technology, the latest tool in its portfolio of non-contrast-based solutions for shock and trauma care. The company claims it is the first and only medical device cleared by the agency to detect suspected intracranial hemorrhage (ICH) and large vessel occlusion (LVO) from value-based CT imaging.
The €13.8 million (US$15.25 million) Kiro SAS recently raised in its series A financing led by Sofinnova Partners will enable the company to further develop its artificial intelligence (AI) platform, which standardizes and analyzes laboratory test results, making them more relevant to doctors and easier for patients to understand. The funding will also allow the company to prepare the groundwork to enter the U.S. market where, Alexandre Guenoun, CEO at Kiro, told BioWorld, there is a huge “opportunity” for the AI platform following changes to regulations which require laboratories to communicate test results directly to patients.
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.
The U.S. FDA has been working for some time to develop less clunky regulatory mechanisms for digital health products, but Jeff Shuren, director of the agency’s Center for Devices and Radiological Health, has been touting a voluntary alternative pathway (VAP) as a modernized approach to premarket review.
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.
Vitestro Holding BV reported raising $12.7 million in series A financing round to develop the world’s first autonomous blood drawing device. This round was led by Sonder Capital Inc., alongside existing investors and new angel investors with experience in the clinical laboratory and med-tech industry. “Thanks to this fundraising, we are going to accelerate the product development, prepare EU marketing authorization, and initiate production,” Toon Overbeeke, CEO and co-founder of Vitestro, explains to BioWorld.
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.
