Tractus’ Catheter Earns FDA Clearance November 4, 2019 The CSC has been cleared in 0.014, 0.018 and 0.035 guidewire compatibilities and 90, 135, 155, and 170 cm lengths. Read More
FDA Clears Okami’s Vascular Occlusion System November 4, 2019 The system is compatible with microcatheters, allowing it to navigate the peripheral vasculature. Read More
TGA Approves Mallinckrodt’s Uvadex for Use With Cellex Platform November 1, 2019 The photopheresis system combines cell collection, photoactivation and reinfusion technologies in a single closed system. Read More
FDA Clears BD’s Antibiotic-Resistant Bacteria Test October 31, 2019 Early detection of patients infected with the antibiotic-resistant organisms can help physicians target infection control measures. Read More
Calprotectin Test Earns 510(k) Clearance October 31, 2019 Calprotectin is a biomarker for identifying inflammation in the gastrointestinal tract associated with irritable bowel syndrome. Read More
NeoDynamics’ Gets Clearance for New Version of Its Breast Cancer Biopsy Device October 30, 2019 The company plans to launch the updated system in mid-2020. Read More
Implanet Earns 510(k) Clearance for Cemented Version of Total Knee Prosthesis October 30, 2019 The knee prosthesis is now available in multiple versions. Read More
FDA Clears HeartVista’s AI-Assisted Cardiac MRI Software October 30, 2019 The software flags when image quality is subpar. Read More
Invo Bioscience Earns CE Mark for Fertility Device October 29, 2019 The product previously received the FDA’s de novo approval in November 2015. Read More
Insulet Earns Additional FDA Clearance for Insulin Management Systems October 28, 2019 The system can now be used with the full spectrum of insulin, from generic to branded to ultra-fast-acting, the company said. Read More
FDA Gives Flowonix’s Programmable Pump the Go-Ahead October 25, 2019 The implantable device allows therapy to be managed with lower doses of medication compared to orally ingested drugs. Read More
Disposable Endoscope Shield Gains FDA Clearance October 25, 2019 Cleaning and disinfecting duodenoscopes is difficult because of their intricate moving parts. Read More