Collagen Matrix’s Moldable Spinal Bone Graft Cleared by FDA April 17, 2019 The product is slowly resorbed in the healing process and replaced by new bone tissue. Read More
FDA Approves Circassia’s COPD Combination Product April 17, 2019 The multi-dose inhaler relaxes the patient’s airway muscles. Read More
Intact Vascular’s Dissection Repair Device Gains CE Mark April 16, 2019 The implant treats vessel injuries and dissections caused by angioplasty balloon inflation. Read More
SOPHiA Nabs CE Mark for Tumor Detection Device April 12, 2019 The device characterizes genomic alterations in 42 genes linked to solid tumors. Read More
Bedfont’s Carbon Monoxide Monitor Nets FDA Clearance April 12, 2019 Healthcare professionals can choose between a mouth piece or a face mask for injured or unconscious patients. Read More
FDA Clears Getinge’s Life Support Device Upgrade April 12, 2019 The upgrade adds new features to the device, including context-based guidance. Read More
GenePOC CE Marked for CPO Diagnostic Test April 11, 2019 The organisms are common in many countries. Read More
FDA Clears Elucent’s Surgical Navigation System April 11, 2019 The system allows physicians to mark difficult-to-access lesions. Read More
Butterfly Network Gains CE Mark for Handheld Ultrasound System April 11, 2019 The device includes an app enabling access from the web or a user’s smartphone. Read More
FDA Issues Warning for Pre-Owned and Unauthorized Test Strips April 10, 2019 Pre-owned test strips may deliver inaccurate results, the agency said. Read More
Nanobiotix’s Nanoparticle Radioenhancer Receives CE Mark April 10, 2019 The nanoparticles are injected into a tumor after initial radiotherapy treatment. Read More
Avinger’s Image-Guided Atherectomy Device Cleared by FDA April 10, 2019 The device includes an improved cutter design and a superior optical coherence tomography imager. Read More