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CMS initiates ‘major’ crackdown on healthcare fraud
The initiative includes a nationwide moratorium for durable medical equipment (DMEPOS) suppliers and a freeze on $259.5m in federal Medicaid funding in Minnesota.
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FDA warns medical device maker about clinical trial, premarket violations
According to the regulator, ExThera Medical sent its Seraph 100 blood filters to a hospital for emergency/compassionate use without first obtaining permission.
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Medical technologies in defense and aerospace
Key themes and emerging questions in regulation.
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FDA signals less regulation for wearable devices, AI providing non-medical information
According to new guidance, certain devices and software that track metrics such as heart rate and activity level will require less rigorous pre-market reviewal.
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How the ‘Brussels effect’ backfired
Once a model for the world, the EU’s rulemaking machine has faltered under the weight of its own ambition.
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A transformational 2025 in US healthcare – and more to come in 2026
In many ways, 2025 found the healthcare sector at a crossroads, with compliance officers holding their heads.
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Wearable maker Whoop continues to push back against FDA warning
Dispute centers on whether wearable wellness kit should be classified as medical devices.
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Understanding FDA cybersecurity requirements for medical devices and FCA enforcement
Key considerations for medical device manufacturers and how to prepare for a cybersecurity incident.