FDA Clears OrSense’s Hemoglobin Measurer for Blood Bank Use May 16, 2019 The device was previously cleared by the agency for hospitals, doctor’s offices and public health departments. Read More
Gore Gains FDA Approval for Stent Graft May 16, 2019 The graft features a staged deployment process for increased accuracy during placement. Read More
Thrombolex Nabs 510(k) Clearance for Catheter System May 16, 2019 The system includes six expandable mini-infusion catheters, allowing the physician to deliver fluids in specific locations. Read More
Roche Gets CE-IVD Mark for Tuberculosis Antibiotic Resistance Assay May 15, 2019 The highly-sensitive test help speed up the diagnosis and treatment. Read More
Haemonetics Earns Expanded Indication for Hemostasis Analyzer May 15, 2019 The system can generate results in ten minutes. Read More
FDA Clears AI-Based Pneumothorax Alert Technology May 15, 2019 The system can potentially lower turnaround time for radiologists. Read More
Balt’s Aspiration Catheter Gains CE Mark May 14, 2019 Balt says the device is part of the company’s “complete stroke solution.” Read More
Tenex Gains FDA Clearance for Bone Remover May 13, 2019 The device can treat soft tissue but was designed to remove bone spurs and osteophyte formations and calcific tissue. Read More
BioTrace Medical’s Wins CE Mark for Temporary Pacing Lead May 10, 2019 The device can potentially avoid permanent pacemaker implantation in patients. Read More
BioCardia’s Steerable Catheter Introducers Earn FDA Clearance May 10, 2019 The products include spiral-arranged pull-wires for better control and stability. Read More
InDevR Gains Market Clearance for Influenza A+B Assay May 10, 2019 The assay can both characterize a variety of viruses as non-seasonal and characterize seasonal viruses. Read More
Exact Imaging Nabs CE Mark for Abdominal Imaging Addition May 9, 2019 The release helps to further the usefulness of ExactVu for men’s health imaging, the company said. Read More