FDA Gives 510(k) Clearance to NeuraMedica’s DuraFuse Dural Clips September 7, 2022 The company plans to launch the clips later this year. Read More
eCential Robotics Gets 510(k) Clearance for Surgical Robotic Platform September 7, 2022 The company is also developing apps for multiple surgery indications. Read More
SkylineDx Receives CE-IVD Mark for Its Merlin Assay September 6, 2022 SkylineDx said it is launching the Merlin assay in Europe this month. Read More
Thermo Fisher Scientific Gains CE-IVD Mark for Two Oncomine Tools September 6, 2022 The company intends to combine the tools with its Ion Torrent Genexus Dx sequencer. Read More
Viz.ai’s Automated RV/LV Algorithm Gets 510(k) Clearance September 6, 2022 The device can detect both clots in the lungs and degree of strain on the right heart. Read More
Laseroptek Receives 510(k) Clearance for Its Helios IV-785 Laser System September 6, 2022 The system can be used for skin toning and brightening, removing benign pigmented and vascular lesions, and multi-color tattoos. Read More
IncellDx Gains CE-IVD Mark for ‘Long COVID’ Diagnostic September 2, 2022 The blood test showed more than 90 percent accuracy in a validation study. Read More
Baxter International Gets 510(k) Clearance for Novum IQ Syringe Infusion Pump September 2, 2022 Baxter’s 510(k) application for its large volume Novum IQ pump is still pending. Read More
Serpex Medical Recon Steerable Sheath Gets 510(k) Clearance September 1, 2022 The sheath is Serpex Medical’s first steerable instrument to gain FDA’s clearance. Read More
FDA Approves Rafa Laboratories’ Midazolam Autoinjector August 31, 2022 The autoinjector can also be used to treat seizures resulting from nerve agent exposure. Read More
Galaxy Medical Gets CE Mark for Centauri PEF System August 30, 2022 Galaxy Medical is partnering with several European centers for the initial launch. Read More
Neuronetics Receives 510(k) Clearance for D-Tect MT Accessory August 30, 2022 The accessory is designed to recognize movement in three areas of the hand. Read More