KDx Diagnostics Earns CE Mark for Bladder Cancer Test July 6, 2020 Bladder cancer has a high recurrence rate that requires frequent retesting. Read More
Venus Concept Snags 510(k) Clearance for Skin Rejuvenation Device July 6, 2020 The company plans a limited launch of the product by the end of the third quarter. Read More
FDA Issues Emergency Use Authorization for Centogene’s COVID-19 Assay July 6, 2020 The test is intended for use in the company’s high-complexity laboratories in Germany. Read More
United Arab Emirates Firm Draws Warning for At-Home COVID-19 Test July 2, 2020 The FDA said it has not approved any COVID-19 tests for at-home use. Read More
New Laser-Based Endoscope for Bladder Cancer July 2, 2020 The project includes photonics specialists from across Europe and Taiwan. Read More
Kardium Earns CE Mark for Globe Mapping and Ablation System July 2, 2020 Kardium has formed a subsidiary in Germany to handle commercial sales of the system in Europe. Read More
Kroger’s COVID-19 Test Home Collection Kit Cleared for Emergency Use July 2, 2020 The agency said promotional material for the home collection kit must make clear that it has not been FDA cleared or approved. Read More
MHRA Warns of Defect in Philips’ Defibrillator Selector Switch July 1, 2020 The device may fail to turn on or may deliver a shock at a different energy level than selected, the agency said. Read More
Masimo Earns De Novo Classification for Opioid Withdrawal Device July 1, 2020 The device is applied to patients by a healthcare professional in a nonsurgical procedure. Read More
Abbott, Tandem Diabetes Team Up on Automated Insulin Delivery Devices July 1, 2020 The companies plan to digitally connect their technologies for automated insulin delivery to simplify how patients manage their diabetes. Read More
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