Caliber Imaging & Diagnostics Gets 510(k) Clearance for VIVASCOPE May 15, 2018 The system provides optical sectioning that can help physicians form a clinical judgment. Read More
CurveBeam Wins 510(k) Clearance for Weight Bearing CT System May 15, 2018 The system previously earned a CE Mark in Europe. Read More
BacterioScan Cleared for UTI Infection Detection System May 15, 2018 The device’s faster detection of infection could lead to less over-prescription of antibiotics. Read More
FDA Clears OrthoPediatrics’ Pediatric Nailing Platform May 15, 2018 The nailing platform, used for the femur, will allow surgeons to treat a wider range of pathologies. Read More
Brainomix Announces CE Mark Certification for e-CTA Software May 11, 2018 The software shows an assessment of the collateral blood supply in a vivid color heat map and visualizes the brain vessels. Read More
Dräger Medical Recalls Fabius Anesthesia Machines May 11, 2018 The devices are inhalation anesthesia machines used in operating, induction and recovery rooms in hospitals and MRI settings. Read More
Faxitron Cleared for Computed Tomography System May 11, 2018 The device reconstructs a specimen in a 3D real-time image. Read More
Chinese FDA Approves Profound’s Sonalleve May 10, 2018 The device combines real-time MRI and thermometry with thermal ultrasound to remove tissue without incisions. Read More
Nova Biomedical Launches Hemoglobin and Hematocrit Meter May 10, 2018 The meter uses a fingerstick capillary sample and can produce results in 40 seconds. Read More
FDA Clears Endoscopic Device for GI Bleeding May 9, 2018 The device is used during an endoscopic procedure and can cover large areas. Read More
C4 Imaging Gains FDA Clearance for MRI Marker May 9, 2018 The device allows the anatomical imaging properties of MRIs to be used in planning treatment and can help minimize side effects. Read More
GI Supply’s Endoscopic Tattoo Launched in Europe May 9, 2018 The device is used to endoscopically mark cancerous tissue, suspicious lesions and polyps for easier identification. Read More