Karius Reports the US FDA’s Breakthrough Device Designation for its Karius Test to Diagnose Infectious Disease
Shots: The US FDA has granted BDD to Karius Test for the diagnosis of immunocompro...
Atraverse Medical Reports the US FDA’s Clearance of Hotwire Left Heart Access Device
Shots: The US FDA has granted clearance to the company’s Hotwire radiofreque...
Profound Medical’s Contouring Assistant AI Module Gains the US FDA’s Approval for Creating Automated TULSA Treatment Plan
Shots: The US FDA has granted 510(k) clearance to the company’s Contouring A...
QIAGEN’s QIAstat-Dx Respiratory Syndromic Testing Panel Gains the US FDA’s Clearance to Diagnose Upper Respiratory Infections
Shots: Following the EUA, the company’s QIAstat-Dx Respiratory Panel Plus sy...
US Medical Innovations Reports the US FDA’s Clearance of Canady Helios Cold Plasma Ablation System for Soft Tissue Ablation
Shots: The US FDA has granted 510k clearance to Canady Helios Cold Plasma (CHCP) S...
Natera Introduces Fetal RhD NIPT Test to Aid Physicians and Patients During RhIg Shortage
Shots: Natera has introduced its new cfDNA-based fetal RhD test aiding physicians...
