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
Insera Gains European Clearance for Stroke Thrombectomy Device April 9, 2019 The device can be used for removal of clots in the neck arteries. Read More
Aggredyne Cleared for ADP Platelet Test April 8, 2019 The assay assesses the effect of various antiplatelet drugs that target the platelet P2Y12 receptor. Read More
Nextremity Gains 510(k) Clearance for Foot Plating System April 4, 2019 The system includes accessory instruments and drill bits for bone insertion. Read More
FDA Clears Avanos Medical’s Drug Infusion Pump April 4, 2019 The device does not use opioids, so patients are not subjected to the potential side effects of narcotics. Read More
Primequal Gains CE Mark for Surgical Glue Applicator April 4, 2019 The company says the device is the first “versatile adhesive applicator kit” to receive the CE Mark. Read More