Medical devices
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CMS proposes to roll back add‑on payment pathway for breakthrough devices
A proposed rule change would require breakthrough devices to meet the same evidence standards as all other new technologies, reshaping reimbursement incentives starting in 2028.
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What the ECJ’s landmark ruling on defective products liability means for life sciences manufacturers
This article covers the expanded litigation risk, the steps life science companies should take to reinforce their product safety, and risk‑management governance.
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Medical device maker Stryker hit by Iranian-based cyberattack
Incident expected to continue causing disruptions and “limitations of access” to company information systems and business applications.
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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.