Class I Recall On Penumbra Revascularization Device
Executive Summary
A delivery wire in the stroke treatment device can break or separate during use, putting patients at risk of worsened stroke, death and other adverse events.
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Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Dealmaking column is a survey of recent health care transactions listed by relevant industry segment – In Vitro Diagnostics, Medical Devices, and Pharmaceuticals – and then categorized by type – Acquisition, Alliance, or Financing. This month’s column covers deals announced in March 2017.
Warning Letters And Close-Outs – September 2023
It was a quiet month for warning letters at the FDA last month, with the agency issuing no new warning letters and closing out only one.
Proposed Rule Would Apply FDA’s Diagnostic Rules To LDTs
A proposed rule from the US Food and Drug Administration would allow the agency to take on regulation of lab-developed tests by phasing out the previous approach of enforcement discretion