Audere’s COVID-19 Test Gets FDA’s Emergency Use Authorization May 5, 2022 The samples can be transported at ambient temperature for testing at a laboratory certified to perform high-complexity tests. Read More
Silk Road Gets FDA’s Premarket Approval for Expanded Indications of its Enroute Stent May 5, 2022 The company was able to demonstrate noninferiority in stroke and death rates for the Enroute stent relative to carotid endarterectomy. Read More
Skin Analytics’ DERM Skin Lesion Software Wins UKCA Mark May 5, 2022 The image analysis software helps dermatologists review referred cases remotely. Read More
Venus Concept Gets FDA Clearance for New Indications of Its BlissMAX May 5, 2022 The company is adding the new indication in its marketing of the subscription-based product in the U.S. Read More
FDA Grants Boston Scientific Clearance for its Embold Fibered Detachable Coil May 4, 2022 The first procedure using the device was performed in late April at the University of Alabama at Birmingham. Read More
Myolyn Gets New FDA Clearance for its MyoCycle Device May 4, 2022 The new models feature more adjustable stimulation parameters and real-time performance feedback. Read More
Boston Imaging’s Mobile Digital Radiography Device Gets FDA Clearance May 4, 2022 The device operates at low noise levels during standby and night mode to avoid disturbing patients. Read More
Dominion Aesthetic’s EON Lipolysis Device Cleared May 4, 2022 The FDA previously cleared the device in February 2021 for use on the abdomen. Read More
Nano-X Gets FDA’s 510(k) Clearance for its HealthOST Software May 3, 2022 The software enables early treatment of osteoporosis patients to prevent major fractures. Read More
FDA Grants 510(k) Clearance to Onera’s Sleep Study System May 3, 2022 The patch-based system is less cumbersome and expensive than existing sleep-testing methods, the company said. Read More
ExsoMed Gets 510(k) Clearance for its NanoPhix System May 3, 2022 The system is designed to enable hand surgeons to properly place the screw tip to avoid skiving off the bone. Read More
Arterys Gets FDA’s 510(k) Clearance for Cardiac MRI Artificial Intelligence Software May 2, 2022 The software enables physicians to easily quantify volumes for both the left and right atria. Read More