Medtronic Gets 510(k) Clearance for RespArray Patient Monitor September 9, 2022 The company plans on a limited market release late in the fourth quarter of this year. Read More
BGI Receives CE-IVDD Certification for Thalassemia Gene Detection Kit September 9, 2022 Blood samples will be used to screen for mutations that indicate hemoglobin deficiencies, the company said. Read More
Magnus Medical Received 510(k) Clearance for Its Saint Neuromodulation System September 8, 2022 The system also received Breakthrough Device designation from the FDA. Read More
Vesalio Receives CE Approval for NeVa NET Device September 8, 2022 The device is expected to improve the standard of care for patients with stroke who need surgery to remove a blood clot. Read More
Noul Gets Two CE-IVD Marks for Diagnostic Test Products September 8, 2022 The company previously received CE-IVD marking for the miLab Platform and the miLab Cartridge MAL in February 2021. Read More
Two Owkin Diagnostics Products Received CE-IVD Mark September 7, 2022 These approvals are the first ones for the company’s diagnostics products. Read More
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