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
Pursuit Vascular’s Barrier Caps Cleared for Killing Catheter Bacteria April 3, 2019 Bloodstream infections from catheters are a leading cause for hospitalization in hemodialysis patients, according to the devicemaker. Read More
FDA Clears Wearable Monitor for COPD Patients April 3, 2019 The data collected by the wristband monitor is automatically analyzed for any clinically relevant signs of deterioration. Read More
ENvizion’s Feeding Tube Placement Device Cleared April 2, 2019 The company said that over six million feeding tubes are inserted per year in the U.S. Read More