Neuro

Spryte Medical Receives FDA IDE Approval to Initiate “INSYTE” US Pivotal Trial evaluating the nOCT Imaging System during Brain Aneurysm Treatment

BEDFORD, Mass., Nov. 19, 2025 (GLOBE NEWSWIRE) — Spryte Medical, a pioneer in intravascular neuro imaging, announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate the INSYTE pivotal trial. The trial will evaluate the safety and effectiveness of Spryte’s neuro Optical Coherence Tomography (nOCT) imaging system for use during intracranial aneurysm treatment procedures.

Philips and Cortechs.ai extend partnership to advance quantitative neuroimaging and strengthen Philips’ leadership in precision diagnostics in neurology

November 19, 2025Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced an extended partnership with Cortechs.ai, a pioneer in quantitative neuroimaging solutions. Together, the companies will integrate Cortechs.ai’s advanced AI-enabled neuroimaging analytics directly into Philips’ MR systems [1], empowering clinicians with faster, more objective, and reproducible insights into brain health. The collaboration strengthens Philips’ leadership in precision neuro diagnostics, combining Philips’ next-generation MR technologies with Cortechs.ai’s AI-driven quantitative neuro imaging post processing software [1] to transform how neurological diseases are detected, monitored, and managed.Combining complementary expertise for smarter brain imagingUp to 25% [2] of all MR procedures are brain scans, and radiology departments face growing demand amid increasing staff shortages. At the same time, the number of patients with neurological conditions such as Alzheimer’s disease, multiple sclerosis (MS), and brain tumors continue to rise globally. Current MR interpretation of neurodegenerative diseases or neuro oncology cases depends heavily on visual assessment, introducing variability and requiring significant expertise and time in an already overloaded system.Through this extended partnership, Philips and Cortechs.ai aim to deliver more standardized and data-driven imaging. By integrating quantitative analysis tools such as brain volumetrics, lesion quantification, and tumor tracking directly into the Philips MR imaging workflow [1], clinicians gain objective, numerical data alongside images – enabling faster, more consistent, and confident diagnoses.Empowering clinicians with precision and speedThe integration of Cortechs.ai’s NeuroQuant® solutions for Alzheimer’s, MS and brain tumors within Philips’ Smart Reading environment – a cloud-based AI platform that combines imaging, reading, and reporting directly on the MR systems [1] – marks a major step toward precision neuroimaging.With this integration, clinicians can automatically receive AI-generated quantitative reports within their standard MR workflow on the MR system or PACS, without adding extra steps for technologists. The zero-click process ensures quality-checked data and standardized outputs, helping radiologists interpret brain scans more objectively, faster and with greater confidence.“By extending our partnership with Cortechs.ai, we are accelerating the transition to fully quantitative, AI-powered neuroimaging,” said Ioannis Panagiotelis, PhD, Business Leader, MRI, Philips. “This integration brings precision, reproducibility, and efficiency to neurological MR, helping clinicians make faster, more confident decisions for patients living with complex brain conditions.”Driving productivity and improving care through AIPhilips is driving productivity and improving care through deep AI integration that tackles some of healthcare’s most pressing challenges – from workforce shortages to the growing demand for advanced diagnostics. By automatically generating quantitative reports within existing workflows, AI helps radiologists save time, improve consistency, and boost throughput. Objective numerical biomarkers enhance diagnostic accuracy, enabling more reproducible assessments and confident comparisons across time and sites. And by minimizing manual post-processing through automated, quality-controlled workflows, technologists can focus more on what matters most – delivering a better, more personalized patient experience.“Cortechs.ai’s mission has always been to empower clinicians with actionable, quantitative insights,” said Kyle Frye, Chief Executive Officer, Cortechs.ai. “By combining our advanced neuro analytics with Philips’ leading MR platform and AI infrastructure, we’re making it easier to personalize brain care and track neurological changes with precision.”Setting a new standard in precision neuro diagnosticsCortechs.ai’s  NeuroQuant® solutions are already available on Philips Advanced Visualization Workspace. With this extended partnership, Philips reinforces its commitment to advancing the field of neurology – empowering healthcare providers to deliver better care for more people, in less time, with greater confidence.

Bioxodes presents BIOX-101 clinical data showing breakthrough potential for stroke in webcast with Prof Dr Robin Lemmens

Gosselies, Belgium, 14 November 2025 (08:30 am CET) – Bioxodes SA, a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, has held a webcast on the breakthrough potential of its lead candidate BIOX101 to treat intracerebral hemorrhage (ICH) and discussed the data with Prof Dr Robin Lemmens, KU Leuven, the Principal Investigator of its Phase 2a BIRCH clinical trial. Prof Lemmens, a world-renowned stroke expert and head of the stroke unit at the University Hospital Leuven, underscored the urgent need to address the large unmet medical need in intracerebral hemorrhage, and provided his insights from the successful Phase 2a clinical study with BIOX-101. Bioxodes CEO Marc Dechamps presented the company’s strategy in bringing BIOX-101 to market, possibly as early as late 2030.

XCath Endovascular Robotic System Successfully Performs its First-In-Human Brain Aneurysm Procedures

HOUSTON–(BUSINESS WIRE)–XCath, a medical device company dedicated to pioneering neuro-endovascular surgical robotics, announced today the successful first-in-human use of its EVR robotic system to treat three patients with complex brain aneurysms. The landmark procedures were performed at The Panama Clinic in Panama City, Panama, led by Vitor Mendes Pereira, M.D., […]

Kaneka Expands Global Reach with i-ED COIL™ Launch in Europe

TOKYO–(BUSINESS WIRE)–Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Kazuhiko Fujii) (TOKYO:4118) has begun sales of its i-ED COIL™, a brain aneurysm embolization coil (*1), in Europe as of October. The product obtained EC certification (*2) under an EU Medical Device Regulation (*3) in July and will be distributed primarily in Europe […]

Silver Creek Pharmaceuticals Announces Positive Phase 2 Results for Scp776 in Acute Ischemic Stroke

Key Highlights Scp776 is the first therapy to show clinically meaningful efficacy in late-window stroke patients (treated up to 24 hours after onset) – a population with no approved drug options. Scp776 was safe and well-tolerated, with no increase in serious adverse events versus placebo. Scp776 leverages Silver Creek’s proprietary […]

Basking Biosciences Doses First Patients in Part B of Phase 2 Stroke Trial, Unlocks $27.5 Million Financing Tranche, and Appoints Julia C. Owens, Ph.D. as Chief Executive Officer

-Financing supports execution of Phase 2b RAISE trial evaluating BB-031, an investigational reversible thrombolytic for acute ischemic stroke, and the planned Phase 1 study of BB-025, its fast-acting reversal agent- -Current CEO Richard Shea transitions to President and Chief Operating…

Hyperfine Announces First Patients Enrolled in PRISM PMR to Evaluate the Use of Next-Generation Swoop® System in the Operating Room Setting

With several patients already enrolled in the study, PRISM PMR is designed to evaluate the Swoop® system’s clinical utility in the operating room. GUILFORD, Conn.–(BUSINESS WIRE)–Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® […]