FDA Grants SeaStar Medical’s Selective Cytopheretic Device Breakthrough Device Designation for Hepatorenal Syndrome
This is the third Breakthrough Device Designation granted by the FDA to SeaStar Medical for the SCD device,…
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19 Oct 23
This is the third Breakthrough Device Designation granted by the FDA to SeaStar Medical for the SCD device,…
18 Oct 23
Trio of Clearances Expands VySpine’s Growing Product Portfolio
04 Oct 23
First-of-its-kind authorization provides potential marketing differentiation and opportunities for largest testing category
03 Oct 23
Developed in partnership with Mayo Clinic, ECG-AI LEF is an artificial intelligence-driven software-as-a-medical device to screen LEF using…
02 Oct 23
The FDA has granted the breakthrough status to SCD for use with patients in the hospital intensive care…
29 Sep 23
The SunSCAN 3D water scanning system is designed to support annual quality assurance in radiation therapy, beam scanning,…
28 Sep 23
Following the approval, the US-based EnCompass Technologies plans to immediately start clinical site start-up activities in patients undergoing…
28 Sep 23
Company Continues to Build Momentum with Most Recent Portfolio Expansion.
27 Sep 23
The world’s first such robotic platform is intended to ease ear, nose, and throat surgical procedures, including instrument…
26 Sep 23
Thermal Boost is the firm’s first FDA-cleared TULSA AI module which enables predictable, tailored ablation at the prostate…