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 […]
CE Mark
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 […]
Safe Orthopedics nabs CE mark for Hickory screw
Safe Orthopedics today said it received CE mark approval for its Hickory screw for osteoporotic patients. Hickory is a new pedicle screw in the France-based company’s SteriSpine PS range that improves bone anchorage in osteoporotic patients. The company designed Hickory to be securely fixed into a vertebral pedicle to reduce the risk of instability from […]
Lucid Diagnostics gains CE mark for esophageal device
Lucid Diagnostics has received the CE mark for its EsoCheck esophageal cell collection device, its parent company announced today. EsoCheck is an FDA-cleared, swallowable balloon capsule catheter that enables a clinician to sample surface cells from the esophagus in a less than five-minute, non-invasive office procedure. Lucid touts EsoCheck as the only such device capable of […]
Medtronic wins CE mark for smart insulin pen, Guardian 4 sensor
Medtronic (NYSE:MDT) announced today that it received CE mark approvals for its InPen smart insulin pen and its Guardian 4 sensor. Fridley, Minn.–based Medtronic’s new European approvals cover expanded functionality of the InPen for multiple daily injections (MDI), along with approval for the Guardian 4 sensor that requires no fingersticks for calibration or diabetes treatment decisions, […]
Ibex AI-enabled breast cancer diagnostic lands CE mark
Ibex Medical Analytics announced today that it received CE mark approval for its Galen AI-based breast cancer diagnostic platform. Tel Aviv, Israel–based Ibex’s Galen platform uses AI and machine learning technology based on hundreds of thousands of image samples scanned from biopsy slides through digital pathology, according to a news release. Galen previously won CE […]
PAVmed wins CE mark for carpal tunnel device
PAVmed (NSDQ: PAVM) today announced that it has received the CE mark for its CarpX minimally invasive carpal tunnel device. EU-based Notified Body TÜV Rhineland LGA Products GMBH issued CE certificate, effective May 24, 2021, the company noted. CarpX may now be marketed in CE Mark European countries, which include the European Economic Area (the EU, […]
Boston Scientific gets CE mark approval for single-use bronchoscope
Boston Scientific today said it received CE mark approval for its Exalt Model B single-use bronchoscope. The Marlborough, Mass.–based company designed the device for bedside procedures in the intensive care unit, operating room and bronchoscopy suite. Get the full story on our sister site, Medical Tubing + Extrusion.
