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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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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Digital therapeutics (DTx), software as a medical device, present a promising avenue for addressing the increasing burden of a range of conditions, yet their widespread implementation remains contingent upon demonstrating economic value—an understudied domain…
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A £4.2 million MedTech accelerator programme has launched, which will provide up to 140 UK small and medium-sized enterprises (SMEs) with grants to tackle regulatory challenges.
The six-month MedTech Accelerator: Rapid Regulatory Support Fund (MARRS)…
News
The American Hospital Association asks Congress to employ flexibility in any decisions to regulate AI in healthcare, proposing use of a sliding scale that is based on risk and the level of human oversight…
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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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