Personal Genome Diagnostics Gains CE Mark for Plasma-Based Oncology Test March 14, 2019 The test received the FDA’s breakthrough designation in July 2018. Read More
FDA Grants Premarket Approval for BD’s Venous Stent March 14, 2019 The stent is for treatment of both post-thrombotic and non-thrombotic lesions. Read More
FDA Clears Catalyst OrthoScience’s Uncemented Humeral Implant March 13, 2019 The implant restores joint motion in the shoulder. Read More
Boston Scientific Receives CE Mark for New Version of Anti-Stroke Implant March 13, 2019 The new implant offers customized placement. Read More
J&J Earns CE Mark for Photochromic Contact Lens March 13, 2019 The company calls the lens an “entirely new category.” Read More
Sonavex’s Blood Flow Monitor Cleared by FDA March 12, 2019 The device uses deep learning algorithms with 3D ultrasound imaging to measure a patient’s blood flow after surgery. Read More
Alcyone Lifesciences Gains Breakthrough Device Designation for ThecaFlex March 12, 2019 The device is designed for patients who cannot undergo lumbar punctures. Read More
Admedus Gains CE Mark for Collagen Bioscaffold March 12, 2019 The bioscaffold reduces the need for hemostatic agents. Read More
FDA Clears Epithelial Thickness Mapping for Cirrus Platform March 12, 2019 The device helps identify patients eligible for refractive surgery. Read More
Agfa Receives 510(k) Clearance for Imaging System March 11, 2019 The software can reconstruct images in less than a minute. Read More
FDA Hands Paige.Ai Breakthrough Designation for Cancer Diagnosis Tool March 11, 2019 The software uses an artificial intelligence algorithm that is trained using expert cancer diagnoses. Read More
Voluntis Cleared for New Version of Type 2 Diabetes App March 7, 2019 The app can help NPH insulin patients reduce day-to-day challenges. Read More