FDA Clears Getinge’s Life Support Device Upgrade April 12, 2019 The upgrade adds new features to the device, including context-based guidance. Read More
GenePOC CE Marked for CPO Diagnostic Test April 11, 2019 The organisms are common in many countries. Read More
FDA Issues Warning on Using Illicit Head Injury Diagnosis Devices April 11, 2019 Only a “limited number” of devices are cleared or approved to help manage or detect concussion, the agency said. Read More
FDA Clears Elucent’s Surgical Navigation System April 11, 2019 The system allows physicians to mark difficult-to-access lesions. Read More
Butterfly Network Gains CE Mark for Handheld Ultrasound System April 11, 2019 The device includes an app enabling access from the web or a user’s smartphone. Read More
FDA Issues Warning for Pre-Owned and Unauthorized Test Strips April 10, 2019 Pre-owned test strips may deliver inaccurate results, the agency said. Read More
Nanobiotix’s Nanoparticle Radioenhancer Receives CE Mark April 10, 2019 The nanoparticles are injected into a tumor after initial radiotherapy treatment. Read More
Avinger’s Image-Guided Atherectomy Device Cleared by FDA April 10, 2019 The device includes an improved cutter design and a superior optical coherence tomography imager. Read More
FDA Grants Clearance for Ortho Clinical’s Chemistry Product Slides April 10, 2019 The microslides enable a higher test throughput and require smaller blood samples. Read More
iSchemaView Nabs Israel’s Approval for Stroke Imager April 9, 2019 The device provides physicians with color-coded maps of the brain. Read More
Bluejay Diagnostics Earns CE Mark for Allergic Conjunctivitis Test April 9, 2019 Use of the diagnostic test at point-of-care could help avoid unnecessary eye treatments and antibiotic regimens. Read More
FDA Clears Bio-Rad Blood Screener April 9, 2019 The device can process the company’s entire range of gel cards. Read More