Senseonics (NYSE:SENS) announced today that its Eversense NOW remote monitoring app for Android received CE mark approval. Germantown, Maryland–based Senseonics already received such approval for the Eversense NOW iOS platform and can now offer it in Europe on the Android operating system. The company expects to make the Eversense NOW remote monitoring app for Android available […]
CE Mark
Baxter, Biomérieux win CE mark for test predicting persistent severe acute kidney injury
Baxter (NYSE:BAX) and Biomérieux (EPA:BIM) today announced CE mark approval for their Nephroclear CCL14 test. The companies designed the Nephroclear CCL14 test to predict persistent severe acute kidney injury (PS-AKI). It can be used to support timely clinical decision-making and care pathways, according to a news release. Baxter and Biomérieux plan to launch Nephroclear CCL […]
Cepheid wins CE Mark for COVID-19, flu, RSV combo diagnostic
Cepheid announced today that it received CE mark approval for its Xpert Xpress CoV-2/Flu/RSV Plus rapid molecular diagnostic. Sunnyvale, California-based Cepheid last month received FDA emergency use authorization (EUA) for the Xpert Xpress CoV-2/Flu/RSV Plus diagnostic. The company designed its Xpert Xpress Plus as a rapid molecular diagnostic test for the qualitative detection of the viruses […]
Medtronic’s Hugo robotic-assisted surgical system wins regulatory nod in Europe
Medtronic (NYSE:MDT) announced that it received CE mark approval in Europe for its Hugo robotic-assisted surgery system. Fridley, Minnesota-based Medtronic’s CE mark covers urologic and gynecologic procedures, which make up approximately half of all robotic procedures performed today, according to a news release. Last month, the company said it had been expecting to receive such […]
Ambu secures CE mark for single-use bronchoscope and sampling system
Ambu recently announced that its single-use bronchoscope and specimen sampling system won CE mark approval. Ambu’s aScope 4 Broncho sampler set is a sterile, single-use device for bronchial wash and bronchoalveolar lavage procedures. Get the full story on our sister site, Medical Tubing + Extrusion.
Medtronic wins CE mark approval for radial artery access portfolio
Medtronic today said it has received CE mark approval for its radial artery access portfolio. The radial artery access devices include the Rist 079 radial access guide catheter and the Rist radial access selective catheter. Medtronic designed the Rist 079 guide catheter to access the neuro vasculature through the radial artery instead of through the […]
Nuwellis wins CE mark for 24-hour blood circuit set for use with Aquadex SmartFlow
Nuwellis (NSDQ:NUWE) announced today that it received CE mark approval for its 24-hour blood circuit set for use with the Aquadex SmartFlow. Eden Prairie, Minnesota-based Nuwellis — formerly CHF Solutions — can now market the 24-hour blood circuit set (UF 500-24 Hour) in the European Union and other locations that recognize the CE mark. According […]
CoapTech wins CE mark for ultrasound gastrostomy system
CoapTech announced today that it received CE mark approval and an approved CPT procedure code for its PUMA-G ultrasound gastrostomy system. Baltimore-based CoapTech’s PUMA platform consists of minimally invasive devices designed to enable ultrasound for use in procedures in hollow organs of the body in which it was previously impossible or unsafe to do so, […]
Abbott wins new FDA approvals for stent family including nod for next-gen Xience Skypoint
Abbott (NYSE:ABT) announced today that the Xience stent family received FDA approval for one-month dual antiplatelet therapy (DAPT) labeling. The FDA’s approval for one-month (as short as 28 days) DAPT labeling applies to high bleeding risk (HBR) patients in the U.S., according to a news release. The company also recently received CE mark approval in […]
NuVasive’s updated Pulse spinal surgery platform wins CE mark
NuVasive (NSDQ:NUVA) announced today that it received CE mark approval for the latest updates to its Pulse spinal surgical automation platform. San Diego–based NuVasive touts its Pulse system as a first-of-its-kind technology designed to integrate radiation reduction, imaging enhancement, rod bending, navigation, intraoperative neuromonitoring and spinal alignment tools into one platform. According to a news […]
Viz.ai wins CE mark for AI-powered stroke care software
Viz.ai announced today that it received CE mark approval for its flagship Viz LVO AI-based stroke care software platform. San Francisco–based Viz.ai developed Viz LVO to use AI to automatically detect suspected large vessel occlusion (LVO) strokes on computed tomography angiography (CTA) imaging. Once the platform detects stroke, it directly alerts on-call stroke specialists about […]