Class I Recall On Penumbra Revascularization Device
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.
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.
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