SeaStar’s selective cytopheretic device wins FDA breakthrough designation

The US Food and Drug Administration (FDA) has granted breakthrough device designation to SeaStar’s selective cytopheretic device (SCD), meaning the…

Koru Medical submits PMA for infusion system

Koru Medical has submitted a 510(k) premarket notification (PMA) to the US Food and Drug Administration (FDA) for its FREEDOM60…

Thermo Fisher agrees to acquire CorEvitas for $913m

Thermo Fisher Scientific has signed a definitive agreement for the acquisition of US-based data intelligence company CorEvitas from Audax Private Equity in…


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