FDA's Device Center Faces New Charge Of Whistleblower Retaliation

Federal officials took steps last week to reinstate a recently fired reviewer in FDA's diagnostics office, claiming that agency actions may have violated the Whistleblower Protection Act.

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Medtronic, Philips Cement New Pact To Embed Next-Gen Tech In Monitoring Platforms

 
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Under the terms of the new agreement, Philips will also begin bundling essential supplies – including ECG, noninvasive blood pressure (NIBP) components, and batteries – with its Medtronic-enabled monitors.

Bivacor Rotary Heart Could Upend The Artificial Heart Market, If It Reaches Its Destination

 
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Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.

Study: FDA’s Breakthrough Path Speeds Access, But Raises Safety Questions

 
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Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.