Omnihuman VR is a personalised telerehabilitation tool that uses music stimulation to improve compliance with upper-limb rehabilitation exercises for stroke survivors. The product supports clinicians by tracking patient progress through a dashboard, collecting data…
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After an exciting few months of collaboration, learning and regulatory light-bulb moments, the RADIANT-CERSI DigitalHealth.London Innovator Support Programme has concluded its first cohort. From simplifying medical device regulation to empowering digital health innovators across the UK, the programme has been…
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8foldGovernance supports businesses to accelerate MedTech, Digital Health or Medical Service compliance, ensuring both product and business quality. The team join a host of subject matter experts as part of the RADIANT CERSI DigitalHealth.London…
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HIV self-testing (HIVST) allows people to test for HIV outside traditional health facilities, but this presents challenges around pre-and-post-test counselling, reporting results and linking to care. Digital interventions for HIVST, a type of software…
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What You Should Know:
– Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced today that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for ArteraAI…
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What You Should Know:
– Peerbridge Health has announced the launch of its landmark COR-INSIGHT Trial, which will validate the screening and diagnostic capabilities of its Peerbridge Cor® ambulatory ECG wearables.
– The trial seeks to revolutionize cardiovascular…
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What You Should Know:
– BrightInsight, Inc., a provider of regulated digital health solutions, has announced an expanded multi-year partnership with Sanofi, a global biopharmaceutical company. This expanded partnership builds on a successful collaboration that…
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Crafting Superior Health Software: IEC 82304-1 ComplianceIEC 82304-1:2016 is tailored to health software products designed to operate on general computing platforms without dedicated hardware. It is aimed at products intended for the market and…
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ISO 14971 is a pivotal standard for risk management in the design and production of medical devices, emphasizing the importance of assessing and controlling risks throughout a product’s lifecycle. Here’s an in-depth look at…
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Background: The rapid growth of digital health apps has necessitated new regulatory approaches to ensure compliance with safety and effectiveness standards. Nonadherence and heterogeneous user engagement with digital health apps can lead to trial…
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