Pharaoh Neuro Wins FDA Breakthrough Device Designation for Neurapheresis CSF System

• FDA Grants Breakthrough Device Designation to Pharaoh Neuro’s Neurapheresis™ CSF Management System (Regulatory Update)

On 28 October 2026, Pharaoh Neuro received FDA Breakthrough Device Designation for its Neurapheresis Cerebrospinal Fluid Management System, which was developed to accelerate the removal of blood and blood-breakdown products from cerebrospinal fluid following aneurysmal subarachnoid hemorrhage. The external, automated system used a closed-loop process to collect, filter, and return cerebrospinal fluid without introducing replacement fluids. The designation provided the company with opportunities for closer engagement with the FDA as it advanced the device toward potential marketing authorization. This development highlighted progress in innovative neurocritical care technologies and addressed an unmet need in managing complications associated with hemorrhagic stroke. However, the system remained investigational and had not received FDA clearance or approval for commercial use.

“The Breakthrough Device Designation is a significant milestone for Pharaoh Neuro,” said Amaza Reitmeier, Chief Executive Officer. “It validates our belief that Neurapheresis offers significant advantages over existing approved or cleared alternatives. We look forward to working closely with the agency to bring this technology to patients as quickly as possible.”

As per DelveInsight’s “Cerebrospinal Fluid Management – Market Insights, Competitive Landscape, and Market Forecast – 2034,” The global cerebrospinal fluid management market size was valued at USD 705.94 million in 2025 and is projected to reach USD 1,112.15 million by 2034. The market is expected to expand at a CAGR of 5.18% during the forecast period 2026-2034, supported by the rising incidence of neurological and cerebrospinal disorders, a growing number of trauma and accident cases globally, and an increased focus on innovative product development.

• SEKISUI Diagnostics Announces 510(k) Clearance and Launch of the OSOM® COVID-19/Flu A&B Combo Test (Regulatory Update)

On 27 October 2026, SEKISUI Diagnostics received FDA 510(k) clearance and introduced its OSOM COVID-19/Flu A&B Combo Test for use in professional healthcare settings. The rapid diagnostic assay employed lateral-flow immunochromatographic technology to detect and differentiate influenza A, influenza B, and SARS-CoV-2 antigens from a single anterior nasal swab sample. The test was granted CLIA-waived status for point-of-care testing, allowing healthcare professionals to identify common respiratory viral infections and support timely treatment decisions. The company also incorporated an integrated quality-control feature that provided two additional tests for external quality assessment without separate costs. The launch expanded SEKISUI Diagnostics’ respiratory testing portfolio and strengthened the availability of FDA-cleared diagnostic solutions amid the transition away from emergency use authorizations.

“With the Emergency Use Authorization ending, we know it is extremely important to continue to supply the market with the tools needed to diagnose respiratory infections quickly and accurately. We are pleased to be able to offer new customers and transition existing customers to a 510(k) cleared alternative as we enter the season, so they are well prepared before the termination takes effect,” said Erica Blight, VP Strategy & Growth.

As per DelveInsight’s “Rapid Diagnostic Kits – Market Insights, Competitive Landscape, and Market Forecast – 2030,” The global rapid diagnostic kits market was valued at USD 14.12 billion in 2023, growing at a CAGR of 3.55% during the forecast period from 2024 to 2030, to reach USD 17.38 billion by 2030. The stellar growth observed in the rapid diagnostic kits market is primarily owing to the rising prevalence of diabetes globally, the increasing prevalence of COVID-19, the increasing incidence of Human Immunodeficiency Virus (HIV) infection, the increased regulatory approval of rapid diagnostics kits in the market, and the increase in demand of point-of-care immunodiagnostic tests are some of the factors propelling the market for rapid diagnostic kits during the forecast period from 2024 to 2030.

• SetPoint Medical Announced First SetPoint® System Procedure in Boston at Beth Israel Deaconess Medical Center (Commercial Update)

On 28 October 2026, SetPoint Medical expanded the availability of its neuroimmune modulation therapy for rheumatoid arthritis by completing its first SetPoint System procedure at Beth Israel Deaconess Medical Center in Boston. The procedure introduced a device-based treatment option for adults with moderately to severely active rheumatoid arthritis who had experienced inadequate responses or intolerance to existing biologic or targeted synthetic therapies. The implantable system stimulated the left vagus nerve to activate the body’s natural anti-inflammatory pathways and regulate immune activity. This milestone strengthened the adoption of neuromodulation-based approaches in rheumatoid arthritis management and expanded treatment access for patients across the New England region.

“The SetPoint System reflects a significant evolution in neuromodulation, applying a targeted, device-based approach to a disease that has long been treated pharmacologically,” said Dr. Aronson. “An outpatient procedure now opens a fundamentally different treatment pathway for patients with rheumatoid arthritis.”

As per DelveInsight’s “Neurostimulation Devices – Market Insights, Competitive Landscape, and Market Forecast – 2032,” The global neurostimulation devices market size is expected to increase from USD 7,862.04 million in 2024 to USD 16,111.10 million by 2032, reflecting strong and sustained growth. The global neurostimulation devices market is growing at a CAGR of 9.44% during the forecast period from 2025 to 2032. The market for neurostimulation devices is growing rapidly, fueled by the rising global prevalence of chronic diseases like pain, epilepsy, and depression. This growth is also driven by significant technological advancements that have made devices smaller, smarter, and more effective. Favorable regulatory policies and better reimbursement coverage are also making these treatments more accessible. Overall, the increasing demand for effective, long-term therapeutic options for neurological and chronic conditions is creating a strong and sustained market.

• HOPPR Expanded Medical Imaging AI Portfolio with Whole-Body Musculoskeletal X-ray Narrative Model  (Commercial Update)

On 28 October 2026, HOPPR expanded its medical imaging artificial intelligence portfolio with the beta launch of a whole-body musculoskeletal X-ray narrative model designed to generate preliminary findings for radiology reports. The model processed up to three X-ray views per study and covered multiple anatomical regions, including the spine, chest wall, upper extremities, pelvis, and lower extremities.

It was trained on approximately 674,000 proprietary outpatient studies and evaluated across 26 categories of musculoskeletal findings, including fractures, degenerative changes, alignment abnormalities, and bone lesions. Through its implementation services, HOPPR enabled healthcare organizations and developers to customize the model and integrate it into existing workflows. The launch represented a further advancement in AI-powered radiology reporting, although the beta software was not FDA-cleared and was not intended for diagnostic use.

“Organizations shouldn’t need a separate AI model for every bone and joint. Musculoskeletal imaging spans the whole body, and a single model trained across it gives developers a far stronger foundation to build on,” said Khan Siddiqui, MD, co-founder and CEO of HOPPR. “The FS MSK Model offers one whole-body model for generating draft findings text, and our Forward Deployed Services team works with each customer to adapt it to their data and workflows.”

According to DelveInsight’s “Artificial Intelligence (AI) in Medical Imaging – Market Insights, Competitive Landscape, and Market Forecast – 2032”, the global artificial intelligence in medical imaging market is expected to increase from USD 1,673.03 million in 2024 to USD 13,181.93 million by 2032, reflecting strong and sustained growth. The global artificial intelligence in medical imaging market is growing at a CAGR of 29.48% during the forecast period from 2025 to 2032. The global artificial intelligence in medical imaging market is being driven by the rising prevalence of chronic diseases such as cancer, cardiovascular disorders, and neurological conditions, which increase demand for accurate and efficient diagnostics. Government initiatives and funding are promoting healthcare digitization and AI adoption, while key players are investing in product development and strategic collaborations to enhance imaging solutions. Rapid advancements in deep learning, machine learning, and computer vision are further improving diagnostic accuracy, workflow efficiency, and predictive capabilities, collectively accelerating market growth across regions.

• Brainomix AI Imaging Analysis of Phase 3 CHARM Trial Identifies Promising Treatment Signals in Severe Stroke Patients (Clinical Update)

On 28 October 2026, Brainomix identified promising treatment-response signals in patients with severe stroke through an artificial intelligence-based analysis of data from the Phase III CHARM clinical trial. The company used its Brainomix 360 Stroke platform to assess brain imaging scans and investigate whether non-contrast computed tomography could help identify patients with large hemispheric infarction who were more likely to benefit from CIRARA, an investigational intravenous glyburide therapy developed by Remedy Pharmaceuticals. The analysis covered 428 patients, with a subgroup of 191 patients whose infarct core volumes were below 125 mL showing a significant association between treatment and improved functional outcomes. The findings demonstrated the potential of AI-assisted imaging to support treatment-response assessment, refine patient selection, and improve the design of future stroke clinical trials. Further investigation was required to confirm the findings and establish the treatment’s clinical benefit.

“Patients with large hemispheric infarction face some of the most devastating outcomes in stroke and have very few treatment options, so it is exciting to see signals that a novel therapy such as CIRARA could offer them real benefit,” noted Dr George Harston, Chief Medical & Innovation Officer at Brainomix and Consultant Stroke Physician at Oxford University Hospitals.

According to DelveInsight’s “Artificial Intelligence (AI) in Medical Imaging – Market Insights, Competitive Landscape, and Market Forecast – 2032”, the global artificial intelligence in medical imaging market is expected to increase from USD 1,673.03 million in 2024 to USD 13,181.93 million by 2032, reflecting strong and sustained growth. The global artificial intelligence in medical imaging market is growing at a CAGR of 29.48% during the forecast period from 2025 to 2032. The global artificial intelligence in medical imaging market is being driven by the rising prevalence of chronic diseases such as cancer, cardiovascular disorders, and neurological conditions, which increase demand for accurate and efficient diagnostics. Government initiatives and funding are promoting healthcare digitization and AI adoption, while key players are investing in product development and strategic collaborations to enhance imaging solutions. Rapid advancements in deep learning, machine learning, and computer vision are further improving diagnostic accuracy, workflow efficiency, and predictive capabilities, collectively accelerating market growth across regions.

• Medtronic Reported Positive Real-World Results for Sphere-9 Catheter and PulseSelect PFA System (Clinical Update)

On 22 October 2026, Medtronic announced positive findings from global real-world registries evaluating its Sphere-9 catheter and PulseSelect pulsed field ablation (PFA) system at the Asia Pacific Heart Rhythm Society (APHRS) 2026 scientific meeting. The APEX registry evaluated 1,050 patients with atrial fibrillation treated using the Sphere-9 catheter, reporting a 1.1% major complication rate.

The REAL PULSE registry included 1,160 atrial fibrillation patients treated with the PulseSelect system and demonstrated a 100% acute procedural success rate, with an acute major complication rate of 0.09%. Additionally, a European APEX registry analysis of 46 patients undergoing ablation for ventricular tachycardia reported 87% acute success and an estimated 75% freedom from recurrence at six months. These findings strengthened the clinical evidence supporting Medtronic’s cardiac ablation technologies and highlighted their potential to expand treatment options for patients with cardiac arrhythmias.

“These favorable results reinforce our confidence in the safety and performance of our ablation technologies worldwide. It is very encouraging to see physicians’ positive response and real-world evidence that supports effective, safe, and efficient care for patients with a wide range of arrhythmias,” said Khaldoun Tarakji, M.D., MPH, Vice President and Chief of Science, Research and Technology, Electrophysiology Therapies at Medtronic.

According to DelveInsight’s “Cardiac Ablation Devices – Market Insights, Competitive Landscape, and Market Forecast – 2030,” the global cardiac ablation devices market is expected to increase from USD 3,832.19 million in 2024 to USD 10,317.88 million by 2032, reflecting strong and sustained growth. The global cardiac ablation devices market is growing at a CAGR of 13.25% during the forecast period from 2025 to 2032. The cardiac ablation devices market is witnessing strong growth, driven by the rising prevalence of cardiovascular disorders, especially atrial fibrillation, and growing patient preference for minimally invasive procedures. Advances in technology, including radiofrequency and cryoablation systems, contact force-sensing catheters, and pulsed field ablation, are improving precision, safety, and outcomes. With manufacturers developing next-generation platforms integrating imaging, mapping, and AI guidance, these factors are expected to sustain robust market expansion in the coming years.