Dot Medical announced today that it received FDA investigational device exemption (IDE) approval for its access management ...

This creates opportunity, but it also creates risk. When a product is used in a clinical setting, even a small issue can have ...

BTIG analyst Ryan Zimmerman said while the increase in approvals is promising, longer decision times may have financial implications.

"Being able to induce a broad range of specific cardiac disease such as HFpEF, which remains one of the least well understood and hardest heart failure conditions to treat, we hope to aid in the ...