Medtronic plc expects its Hugo robotic-assisted surgery system to be a key growth driver, especially when it receives U.S. FDA approval. Already approved for use in Europe, Medtronic recently received CE mark for the Ligasure technology to be used with the Hugo RAS system, expanding its capabilities for gynecologic, general and urologic procedures, across the region.
Neurovalens Ltd raised £6 million (US$8 million) in an investment round for its non-invasive neurostimulation devices, which treat insomnia and manage anxiety. The company will use the funds to expand its presence in the U.S. and accelerate sales of its U.S. FDA-cleared devices, Modius Sleep and Modius Calm. The round was led by the Investment Fund for Northern Ireland (IFNI) with support from new and existing investors.
Stimvia s.r.o.’s Uris system, which delivers peroneal electrical transcutaneous neuromodulation, successfully treated the symptoms of Parkinson’s disease. The non-invasive device, originally developed to treat overactive bladder, safely reduced tremors and improved the quality of life of the patients suffering from Parkinson’s.
Onward Medical NV secured U.S. FDA investigational device exemption (IDE) approval for a pivotal study to assess the safety and efficacy of its implantable spinal stimulation technology, the ARC-IM system. The Empower study BP study will focus on addressing blood pressure instability in patients with spinal cord injury (SCI).
Better Medicine OÜ raised €1 million (US$1.16 million) in a pre-seed funding round for its AI platform, Bmvision Kidney, which uses deep-learning models to detect malignant kidney lesions. The funds will be used to accelerate the rollout of the software across Europe and prepare for U.S. FDA clearance.
Sava Technologies Ltd. raised $19 million in a series A funding round for its multi-molecule biosensor platform that can detect biomarkers just beneath the skin, in real-time. The funds will go towards its first product, a continuous glucose monitor, which early clinical data showed can generate accurate glucose readings for up to 10 days of continuous wear.
Ultromics Ltd. raised $55 million in a series C financing round to expand its commercial footprint across the U.S. and invest in the development of new AI modules for earlier, more accurate detection of cardiovascular disease, Ross Upton, CEO and founder of Ultromics told BioWorld.
Cortec GmbH implanted its brain-computer interface (BCI) system, Brain Interchange, into a stroke patient in late July, joining a host of other companies conducting clinical trials of their BCI technologies to help people affected by neurological conditions recover lost function and improve their quality of life.
Boston Scientific Corp. received CE mark certification under the Medical Device Regulation for its Intracept intraosseous nerve ablation system, bringing another treatment option to patients with chronic pain.
Trinity Biotech plc recently unveiled CGM+, an AI-native, wearable biosensor that goes beyond traditional continuous glucose monitors and tracks glucose levels, cardiovascular activity and body temperature at the same time. The company believes that as precision medicine becomes central to health care, especially with the collection of real-time data, CGM+ will become a critical enabler of AI-based diagnostics, behavioral coaching and chronic disease management.