Avicenna.AI has enjoyed a head-spinning series of regulatory nods for its artificial intelligence (AI)-based solutions for serious vascular conditions including stroke, pulmonary embolism (PE) and aortic dissection. The Marseille, France-based company gained CE mark for its tool that quantifies the severity of a stroke based on a CT scan of the brain and displays regions that have suffered infarcts in late May, followed by CE mark and FDA 510(k) clearance for its product that permits emergency triage of PE and aortic dissection from CT-scan imaging in early June.
Acutus Medical Inc. scored big with regulators in recent weeks. The company, which focuses on devices to diagnose and treat cardiac arrhythmias, received FDA approval to launch an investigational device exemption clinical trial for its Acqblate Force sensing ablation catheter and system in atrial fibrillation just two weeks after gaining CE mark approval for a broad suite of electrophysiology products.
Eyeyon Medical Ltd. has won CE mark approval for its flagship product, Endoart, a synthetic implant that replaces the human endothelium, which the body can’t regenerate. Designed to treat chronic corneal edema, it could help to reduce the long wait times for human donor corneas. Approval was based on a first-in-human trials involving 22 patients who received Endoart implants and were followed for 24 months.
LONDON – Ibex Medical Analytics Ltd. has secured a second CE marking for its Galen artificial intelligence decision support system for automated interpretation of tumor biopsies, adding breast cancer to the approval in prostate cancer secured just over a year ago. The CE mark follows results from a blinded, multicenter clinical study at Institut Curie in France and Maccabi Healthcare Services in Israel. Ibex says that in the trial Galen breast demonstrated very high accuracy in detecting various types of breast cancer.
LONDON – Wise Srl has received CE marking for its cortical strip electrode, validating the underlying flexible electronics technology and opening the door to the development of implantable devices for long-term neurostimulation.
Information Data Systems Inc., doing business as One Drop, has earned the CE mark for its blood glucose prediction analysis engine to accurately forecast glucose levels up to eight hours in advance. The artificial intelligence (AI)-powered tool is indicated for people living with prediabetes, type 2 diabetes, including those on oral medications and/or insulin regimens, and gestational diabetes.
HONG KONG – Celltrion Inc. has received the European CE mark for Tekitrust, its COVID-19 tests kit developed with Mico Biomed Co. Ltd. “Mico, which is a diagnostic device specialist, partnered with Celltrion to combine both companies’ strengths in the test kit sector,” a Celltrion spokesperson told BioWorld. Mico will manufacture the kits, while Celltrion handles marketing and sales.
PARIS – One month before the Medical Device Regulation (MDR) comes into force in the EU, the European Association of Notified Bodies (Team-NB) has released the results of its latest annual survey. This survey of CE-marked medical devices compiled data from 26 notified bodies who were members of Team-NB at the end of 2020. According to Team-NB’s 2020 survey, a total of 18,784 valid CE certificates had been issued by last year, representing an increase of 35% over 2010.
Chicago-based public benefit corporation Neopenda LLC secured the CE mark for its wireless, wearable vital signs monitor and picked up $1.4 million in new funding led by Assiduity Capital and the Sorenson Impact Foundation. The organization developed Neoguard to monitor critically ill infants in resource-poor regions, but adapted it last year to meet the monitoring needs of adult patients with COVID-19. The CE mark approval covers adult, pediatric and neonatal patients.
Fluxergy Inc. said Thursday that it has won CE-IVD marking for its one-hour COVID-19 real-time polymerase chain reaction (RT-PCR) test. The automated, sample-to-action Fluxergy diagnostic testing system can run multiple assay types – such as molecular, immunochemistry, chemistry and cytometry – simultaneously on the same cartridge. The SARS-CoV2 RT-PCR test is the first CE-marked product for the Fluxergy diagnostic platform.
