Genedrive Gains CE-IVD Certification for Human Genotyping Test November 17, 2016 The device performs a 50-minute test with an inner-cheek swab sample. Read More
Xenocor’s Single-Use Laparoscope Receives CE Mark November 17, 2016 The device is used in diagnostic and therapeutic procedures for digestive track surgery. Read More
Cellnovo Submits 510(k) Application to FDA for Diabetes Management System November 16, 2016 Cellnovo’s system has an insulin pump patch and mobile touchscreen controller with a built-in, blood-glucose meter. Read More
Prytime Medical Devices Receives CE Mark November 16, 2016 The device is designed for temporary occlusion of large vessels in emergencies. Read More
Premarket Review Timeframes Improve for Japanese Medical Devices November 16, 2016 Japanese regulators have seen time-accelerated improvement in the device review process. Read More
Boston Scientific Purchases Resectr Tissue Resection Device from Distal Access November 15, 2016 The device is used in conjunction with a diagnostic hysteroscope. Read More
Inscopix Launches an “All-Optical” Brain Mapping Platform November 15, 2016 nVoke combines calcium imaging and neuron illumination, into a single “all-optical” platform. Read More
Ignyta Gains EAP Designation and CE Marking for its Trailblaze Pharos Assay November 15, 2016 The assay is used as an aid in selecting patients with solid tumors that harbor certain gene rearrangements. Read More
LimFlow’s Stent Graph System Receives CE Mark November 15, 2016 The device is for patients who have tried all current revascularization options. Read More
Parexel Launches IDMP-Focused Software and Service Solution November 14, 2016 It is compliant with the five ISO IDMP standards defining product and registration data. Read More
Cardiovascular Systems Signs Distribution Agreement with Medikit for Japan November 14, 2016 The study evaluated the safety and efficacy of the device in treating patients with severely calcified coronary lesions. Read More
InspireMD Gains Commercialization Approval in Russia for CGuard November 14, 2016 The device is designed to prevent peri-procedural and late embolization. Read More