Nevia Bio Ltd. (formerly Gina Life Ltd.) completed a $3.1 million seed round that will allow the company, which has developed a platform that can decode biomarkers data from vaginal secretions for the early detection of ovarian cancer, to conduct clinical trials. With ovarian cancer the leading cause of death in women diagnosed with gynecological cancers, Nevia is hoping that its platform will save many lives.
Babson Diagnostics Inc. has line of sight for the commercial launch of its Betterway blood testing ecosystem, which is a less invasive way of taking blood and requires only one-tenth of the sample volume of venipuncture without sacrificing quality or accuracy. The company said that once the collection device developed in partnership with Becton Dickinson & Co. (BD) is cleared by the U.S. FDA, Betterway will be launched in Texas, where it already has established partnerships with retailers and where its commercial lab is up and running. In addition, Babson has fully validated a broad set of miniaturized assays that are ready for commercial processing in its CLIA-certified, CAP accredited laboratory.
Cathvision ApS received U.S. FDA clearance for two artificial intelligence (AI) models, the PVI Analyzer, and Signal Complexity, which are part of a suite of algorithms designed to help electrophysiologists improve the diagnosis and treatment of complex atrial arrhythmias, including atrial fibrillation. The two algorithms are part of Cathvision’s Cardialytics suite of AI-powered analytics integrated into its Ecgenius system, an electrophysiology recording system that helps with electrogram interpretation.
The $31.4 million investment Capstan Medical Inc. recently received in its Series B funding round will allow the company to make headway in its efforts to use a catheter-based, robotic delivery platform to treat patients with mitral and tricuspid valve disease. With heart disease a leading cause of death globally and cardiac procedures remaining highly invasive and filled with complications, Capstan is working to provide patients with safer, less invasive alternative.
Acorai AB received a U.S. FDA breakthrough device designation for its Heart Monitor, a noninvasive intracardiac pressure monitoring device for patients with heart failure. The Acorai Heart Monitor can estimate diastolic pulmonary artery pressure, systolic pulmonary artery pressure and mean pulmonary artery pressure in patients with Stage C heart failure who have been referred for hemodynamic monitoring.
Exor NV’s acquisition of a 15% stake in Royal Philips NV for approximately €2.6 billion (US$2.8 billion), is a boon for the health care tech company which has been suffering in recent years on the back of a product recall controversy. Netherlands-based diversified holding company Exor will become Philips’ biggest shareholder, and said it is committed to being a “long-term minority investor,” as it grows its investment in the health care sector.
The $1.83 million grant Fesarius Therapeutics Inc. was recently awarded will allow the company to work on the next generation of dermal repair products to treat complex wounds. The funds from the National Institutes of Health (NIH) will go towards further development of the company’s advanced dermal regeneration scaffold for reconstructive surgery and takes the total amount of non-dilutive grant funding Fesarius has received to develop its hydrogel technology, Dermisphere, to $4 million.
Enochian Biosciences Inc.changed its name toRenovaro Biosciences Inc. and reported a deal to merge part of the company with Gedi Cube Intl Ltd. in an effort to move on from recent controversies. “Renovaro, Latin for ‘renewal,’ represents our company’s mission,” said Mark Dybul, CEO of the company.
Theranica Bio-Electronics Ltd. received expanded CE mark approval for Nerivio, a therapy that can both prevent and treat acute migraine in adults and adolescents. The Netanya, Israel-based company is now partnering with a large, publicly traded, pharmaceutical firm to launch the device later this year, first in Germany and then roll out commercial operations in several other European countries in 2024, Alon Ironi, CEO and co-founder of Theranica, told BioWorld.
Trinity Biotech plc. received U.S. FDA 510(k) clearance for its lab-based hemoglobin diagnostic system, the Premier Resolution system, which the company hopes will allow it to regain its market leading position in hemoglobin variant detection. The Premier Resolution system is an automated analyzer which quantifies fetal hemoglobin and hemoglobin A2 and detects more than 200 hemoglobin variants. The device is a modern successor to the company’s Ultra system which once held a leading position in the U.S. hemoglobin variant diagnostic market.
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