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Speaking Of Medtech, Ep. 4: FDA’s Regulation Of Digital Devices
On this episode of Speaking Of Medtech we discuss the regulatory side of digital health – that is, the US FDA side of digital – and some of the more important related policies and activities that are going on at the agency right now.
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Beyond the US market, Monogram is actively pursuing regulatory approvals abroad, with India as a key target. The company has partnered with Shalby Hospitals, one of India’s largest orthopedic hospital networks, to conduct clinical trials and accelerate regulatory clearance in the region.
AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
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Only 16% of venture capital general partners in Europe are women, and only 9% of those have actual investment power. Thena Capital is aiming to "redefine the image of a venture capitalist."
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Exer Labs Inc.’s website marketed its AI-based Exer Scan app to “screen and treat Parkinson’s, TB, Cerebral Palsy and more.” But those claims went well beyond what was allowed under the product’s 510(k) clearance, US regulators say.
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Medical devices, diagnostics, and equipment face tariffs announced by President Donald Trump, despite industry pleas for exemption. The tariffs, ranging from 10%-49%, impact most countries trading with the US, potentially hindering innovation and increasing costs in the medtech sector.
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The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.
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Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.