Embolic Protection: Unmet Clinical Need or Unneeded Technology

While the debate continues about whether embolic protection devices are really necessary, the space continues to generate interest from investors, start-ups and large companies looking for new technologies. Despite the unfulfilled promise of the past decade, interest has spread to new interventional applications such as percutaneous heart valves, indicating that this area remains a viable opportunity for start-ups.

by Mary Stuart

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FDA Scrubs ‘Gender’ From Final Guidance On Sex-Specific Data But Encourages More Women In Clinical Trials

 

The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.