Huma Secures EU MDR Approval For Medtech Software That Can Be Used In Any Disease
Huma Therapeutics has secured the first ever EU regulatory approval for a “disease agnostic” class IIb medtech software platform. CEO Dan Vahdat tells Medtech Insight how the product can be configured to monitor patients with any condition.
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AstraZeneca has been working with Huma to develop a series of software-based tools for monitoring patients. Medtech Insight spoke to both companies about the value of these partnerships and the potential challenges.
MedTech Forum 2023: Why The Commission Must Not ‘Shoot For The Moon’ With EHDS Plans
EU policymakers have ambitious goals to enable greater sharing of electronic health data through the creation of a European Health Data Space, but experts at the MedTech Forum conference urged the commission to ensure its regulation is implementable.
EU AI Act Legal Deep-Dive Part 1: What Can Medtech Expect, And When?
The text of the European Commission’s proposed AI Act is expected to enter the EU high-level negotiation stage within weeks, yet many questions remain as to what the final regulation will entail. Lawyers from Cooley LLP tell Medtech Insight why considerable changes to the text are possible, and what the new law is likely to mean for medtech.