Archive: Company News
C-mo Medical Solutions Receives CE Mark for Its Novel AI-Powered Cough Monitoring Solution
- Regulatory milestone supports broader adoption of C-mo’s privacy-preserving technology in clinical research and medical practice
- Approval covers the biosensor, automated cough monitoring algorithms and software platform
- C-mo allows precise, objective monitoring of cough frequency and intensity across multiple indications
C-mo Medical Solutions, a leading provider of next-generation cough monitoring technology, today announced that it has received CE Mark for C-mo System, its AI-powered cough monitoring solution.
C-mo System is a non-invasive, Class IIa medical device, now CE-marked under EU MDR 2017/745, for monitoring cough in patients across a broad range of indications. The certification covers the biosensor, the automated cough monitoring algorithms and the software platform. Read more…
Nature Translational Psychiatry Study Reveals Distinct Functional Neuronal Signatures in Patient-Derived Brain Organoids with Itay&Beyond’s Neurotech Platform
— Peer-reviewed publication validates the potential of Itay&Beyond’s human CNS platform for advanced disease stratification, translational research, and future therapeutic discovery
— Proprietary platform enables functional analysis of how human neurons behave and communicate in biologically relevant disease models across a broad range of neurodevelopmental and neurodegenerative indications
Itay&Beyond, a neurotech CNS company with a patient-derived brain organoid platform for next-generation neuropsychiatric and neurological drug discovery and development, today announced the publication of novel data in Nature Translational Psychiatry1demonstrating that its pioneering brain-on-a-chip platform, derived from patient urine samples, can reveal functionally distinct neuronal signatures across subpopulations of autism spectrum disorder (ASD). Read more…
EMA Grants PRIME Designation to TolerogenixX’s MIC-Lx Therapy for Donor-Specific Immune Tolerance in Kidney Transplantation
— MIC-Lx therapy receives EMA PRIME designation for its potential to reduce or eliminate life-long immunosuppressive therapy
— Long‑term clinical data with up to 10-year follow‑up support sustained safety and reduced immunosuppression
TolerogenixX, a clinical-stage biopharmaceutical company developing personalized cell therapies to induce sustained immune tolerance in organ transplantation and autoimmune diseases, today announced that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation to its lead cell therapy candidate MIC-Lx for individualized immuno-suppression in living donor kidney transplantation. The PRIME scheme supports medicines addressing serious diseases with significant unmet medical need and provides early and enhanced regulatory interaction with the EMA to accelerate clinical development and patient access.
New data demonstrate medical and health‑economic benefits of digital sleep apnea screening
— Analysis shows significant patient benefit and substantial cost‑saving potential through early digital screening for obstructive sleep apnea (OSA)
— Digital, smartphone‑based solutions enable systematic, low‑threshold screening
— More than 20 percent of the adult population in Germany are affected by obstructive sleep apnea requiring treatment
Obstructive sleep apnea (OSA) is a widespread, chronic condition that often remains undiagnosed for long periods and can lead to serious comorbidities such as hypertension or diabetes. Sleep apnea episodes are breathing pauses of up to one minute, during which the body receives less oxygen. These pauses can occur several hundred times per night and may have substantial health consequences. The risk of stroke is doubled and the risk of heart attack is fourfold increased. This can lead to severe health outcomes and significant costs for healthcare systems. Studies indicate that more than 20% of the adult population in Germany suffer from obstructive sleep apnea requiring treatment.