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 […]
CE Mark
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 […]
Abbott wins CE mark to sell Panbio COVID-19 antigen test over the counter
Abbott (NYSE:ABT) announced today that it received CE mark approval to market the Panbio COVID-19 test for over-the-counter use. European approval covers the direct-to-consumer sale of the Panbio COVID-19 antigen self-test for detecting the SARS-CoV-2 virus in adults and children both with or without symptoms. Abbott Park, Ill.-based Abbott’s Panbio antigen self-test uses a minimally […]
Latest iCad 3D mammography AI gains CE mark
iCad (NSDQ:ICAD) today announced that the third version of its ProFound AI for digital breast tomosynthesis (DBT) has won CE mark approval. Compared with previous software versions, the latest generation of ProFound AI offers up to a 10% improvement in specificity performance while maintaining a high sensitivity level, and approximately 40% faster processing on the new […]
EyeYon Medical corneal endema treatment device wins CE mark
EyeYon Medical announced today that it received CE mark approval for its EndoArt synthetic endothelium replacement implant. Tel Aviv, Israel-based EyeYon designed EndoArt to replace dysfunctional endothelium in patients awaiting human donor tissue as a first-line treatment for patients with chronic corneal edema, as patients with a nonfunctioning endothelium experience excess fluid flowing into the […]
Abbott wins CE mark for Amplatzer steerable delivery sheath
Abbott (NYSE:ABT) announced today that it received CE mark and Health Canada approval for its Amplatzer steerable delivery sheath. The company touts the Amplatzer sheath as the first steerable delivery sheath to be developed specifically for minimally invasive left atrial appendage (LAA) occlusion (or closure) procedures for patients diagnosed with atrial fibrillation who are at […]
Avicenna.AI’s triage system get regulatory nods
Avicenna.AI announced today that it received FDA 510(k) clearance and CE mark for its Cina Chest vascular condition triage system. Marseille, France-based Avicenna.AI designed Cina Chest to leverage deep learning algorithms to offer automatic detection and triage capabilities for both pulmonary embolism (PE) and aortic dissection (AD) from CT-scan imaging, according to a news release. […]
Lucida Medical gains CE mark for cancer-detection software
Lucida Medical announced today that it received CE mark approval for its machine learning-based prostate cancer detection software. Cambridge, UK-based Lucida’s Prostate Intelligence (Pi) software offers a way for radiologists to assess and report MRI imaging studies and support the decision of whether or not to perform a biopsy, while also accurately targeting biopsies where […]
