CoreLink’s 3D-Printed Cervical Spine System Cleared July 1, 2020 The device does not require a supplemental fixation plate, making the surgeries its used in simpler and faster. Read More
FDA Clears Orthofix’s Bone-Screw System for Sacroiliac Joint Dysfunction June 30, 2020 The system is implanted during a minimally invasive surgery that takes about an hour. Read More
Boston Scientific’s Insertable Cardiac Monitor Cleared June 30, 2020 The system uses an algorithm that detects and verifies potential arrhythmias and then sends an alert to clinicians. Read More
ContextVision Earns CE Mark for Prostate Screening Software June 30, 2020 The software can be used alone or alongside existing-picture archiving and communication systems. Read More
Beckman Coulter Snags Emergency Use Authorization for COVID-19 Antibody Test June 30, 2020 The serology test received CE mark certification earlier this month. Read More
Bioventus Bone Graft Strip Gains FDA 510(k) Clearance June 29, 2020 The company said it plans to launch the product in the U.S. in the third quarter. Read More
Pathofinder Launches Second COVID-19 Test June 29, 2020 The test runs on five of the most common real-time PCR instruments. Read More
Medtronic’s Brain Signal-Tracking Neurostimulation System Approved June 26, 2020 Physicians can use the device to deliver more personalized, data-driven neurostimulation treatment, the company said. Read More
DiA Imaging Earns Clearances for AI Ultrasound Analysis Technologies June 26, 2020 The two products to receive clearance are part of DiA’s LVivo Toolbox suite. Read More
VUNO Gets CE Marks for Medical Imaging Software June 25, 2020 VUNO said that it will ship the software internationally. Read More
FDA Grants Premarket Approval for Philips’ Automated External Defibrillators June 25, 2020 The company received premarket approval last year for the first over-the-counter AEDs. Read More
J&J Vision Gets FDA Clearance for Astigmatism Management Software June 25, 2020 The technology minimizes data entry and manual transcription errors. Read More