Naox Technologies SAS secured U.S. FDA 510(k) clearance for Naox Link, its in-ear electroencephalography (EEG) device for clinical use both at home and in health care settings. Naox Link is a pair of earbuds the company hopes will transform how the brain activity is monitored, helping diagnose and track a number of conditions affecting the brain.
Tulyp Medical Inc. has emerged from stealth mode with a pressure-driven perfusion system designed to improve vascular procedures. The company, born out of Sofinnova Partners' medical device accelerator, has submitted the technology to the U.S. FDA for 510(k) clearance following initial clinical results that demonstrated safety and functionality.
French VC Andera Partners has reached the first close of its Biodiscovery Fund 7 at more than €300 million (US$349 million) and says it is on track to surpass the size of the previous fund, which closed at €456 million during the pandemic-driven boom of 2021.
French VC Andera Partners has reached the first close of its Biodiscovery Fund 7 at more than €300 million (US$349 million) and says it is on track to surpass the size of the previous fund, which closed at €456 million during the pandemic-driven boom of 2021.
Rhythm Diagnostic Systems SAS (RDS) raised €14 million (US$16.6 million) in a series A funding round for Multisense, its wearable device that continuously monitors key physiological parameters of patients in hospital or at home. Already CE-marked and deployed in approximately 15 hospitals across France, Belgium and Germany, the funds will enable RDS to expand its commercial and customer support teams and prepare reimbursement filings in key European markets, Elie Lobel, CEO of RDS, told >BioWorld.
Sonomind SAS raised €3 million (US$ 3.5 million) in financing for its transcranial neuromodulation system, which targets deep regions within the brain non-invasively. The funds will go towards accelerating the development of the platform, which has already proven to be safe and effective in treating patients suffering from drug-resistant depression, after only five days of treatment.
Wandercraft SAS secured $75 million in funding in a series D round to grow its AI-powered robotics solutions. Funds will be spent on its exoskeletons, Atalante X and Eve, as well as on the industrial development and rollout of Calvin 40, its humanoid robot.
Chipiron SA will produce a prototype of its ultra-low portable magnetic resonance imaging (MRI) scanner, after raising $17 million in series A financing, as it looks to make MRI more accessible.
Allurion Technologies Inc. is cleared by regulators in France to resume sales of its swallowable gastric balloon to treat obesity, in the country. Last summer, the company withdrew the Allurion Balloon from the French market amid concerns about the safety of the weight loss device. The greenlight to relaunch the product is good news for Allurion given that France represents a sizeable portion of its market.
Ziwig SAS, which leads the race for a simple diagnostic for endometriosis, picked up the pace with a fast-track reimbursement decision in France for its Endotest, the first saliva-based diagnostic assay for endometriosis.