Artificial intelligence (AI)-focused Caption Health Inc. has scored a green light from the U.S. FDA for an updated version of Caption Interpretation, which aims to help clinicians gain quick, easy and accurate measurements of cardiac ejection fraction (EF) at the point of care.
Abbott Laboratories has won the U.S. FDA’s nod for an iOS-compatible app that is designed to optimize care for people using the company’s neuromodulation devices to manage their chronic pain and movement disorders. The digital tool, which can be used on several Apple devices, is part of Abbott’s Neurosphere Digital Care connected care management platform, which launched in May.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Beckman Coulter, Caption Health, Inspiremd, Nobilis, Palliare, Thermo Fisher.
Keeping you up to date on recent developments in diagnostics, including: Scaling patient stratification in EHRs using deep learning; Improving prognosis of pancreatic cancer; Mitochondria, interneurons, cognition link explored.
Exero Medical Ltd. aims to improve monitoring the gastrointestinal system after surgery with a wireless, biodegradable anastomotic leak sensor implant. It has started a tiny five-patient, first-in-human study as a proof of concept for its technology.
PARIS – Inheart SAS completed its first funding round of $4.2 million to improve cardiac arrhythmia treatment using medical imaging, artificial intelligence and digital simulation. This fund round was led by Elvia Partners SAS, a Parisian investment fund managed by Xavier Lazarus specializing in deep tech, and Aquitaine Science Transfer, a company accelerating technology transfer, from the University of Bordeaux.
Hong Kong – Korea’s Ministry of Food and Drug Safety (MFDS) is looking to establish an international common set of guidelines for AI medical devices after its election to the first Chair of Artificial Intelligence Medical Devices (AIMDs) at a meeting of the International Medical Device Regulators Forum (IMDRF).
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Channel Medsystems, Lifesignals, OralDNA Labs, Paige.
Commercial continuous glucose monitors (CGMs) require some access to a patient’s blood, typically through tiny needles embedded in a wearable patch sensor. But Movano Inc. is working to develop a CGM that is based on radio frequency technology to monitor glucose levels via a noninvasive, external wearable, likely in a form factor akin to a watch or a wrist-worn fitness wearable.
Med-tech IPOs continue to make it out onto a strong stock market, even as global economic uncertainty prevails amidst the unfolding pandemic. Single-cell biology research company Berkeley Lights Inc. priced an upsized IPO to raise $178.2 million to back its tools that are used to help develop antibody therapeutics, cell therapies and, more broadly, synthetic biology products.
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