Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has jumped on board the e-consent train for clinical trials, publishing a guidance for the use of electronic means for obtaining a study participant’s informed consent.
China’s recovery from its zero-COVID policy has failed to gain the momentum expected, with many experts predicting a slow or even negative growth rate. A slower economy, combined with a push toward self-reliance, bodes poorly for diagnostics manufacturers in the U.S. who may find themselves not just shut out of the huge market but facing stiffer competition around the globe. Further, policies designed to build a domestic next-generation sequencing industry have created headwinds for San Diego-based Illumina Inc. and others, noted Kyle Mikson and Alex Vukasin of Canaccord Genuity in an in-depth report.
Amsterdam-based Royal Philips NV reported that it has come to terms with customers and end users of its respiratory equipment to the tune of $479 million, which will reimburse for the cost of these systems. The problem for the company is that the settlement does not affect any personal injury cases, and thus represents only a partial closure of a controversy that has dogged the company for several years.
Nemaura Medical Inc. recently raised $6.5 million in non-dilutive funding through a clean debt facility with no warrants or convertible elements. The funding came from its existing lender and is expected to fund Nemaura’s ongoing efforts to commercialize its daily disposable, wearable glucose sensors.
Wearoptimo Pty. Ltd. saw the publication of a patent application for its method and system for analyzing measurements from a wearable patch with sensors connected to microstructures that when applied to the skin penetrate the stratum corneum and enter the viable epidermis.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Asensus, Centinel Spine, Heartsciences, Mephy, Nvidia, Perimeter Medical, Polarean, Positron, Procyrion, Shape Memory Medical, Silony Medical, Tekton, Vida Diagnostics.
AI-Stroke SAS is developing an artificial intelligence (AI)-based application able to detect strokes in real time using a simple smartphone or a tablet. The med-tech firm has just won an award in the i-Lab 2023 innovation competition, supported by the French Ministry of Research and sovereign bank Bpifrance SA. “We use the latest AI and computer vision technology to replicate a neurologist’s expertise immediately anywhere, whereas non-specialists can make diagnostic errors up to 50% of the time,” Cédric Javault, CEO and co-founder of AI-Stroke SAS, told BioWorld.
While the U.S. FDA’s preclinical and clinical trial framework is generally well-suited to adapt to the use of artificial intelligence (AI) in developing new drugs, its regulatory framework for medical devices that incorporate evolving AI leaves a lot to be desired, according to Sen. Bill Cassidy (R-La.), the ranking member of the Senate Health, Education, Labor and Pension Committee.
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