In an age of rapid MedTech transformation, why is diagnostic accuracy so elusive?
For patients facing a potential cancer diagnosis, the heaviest burden isn’t always the treatment; it’s the wait. The wait for clarity. The wait for answers. The wait to know whether something benign could become something more serious. And even today with wearable monitors, AI, robotic surgery, and precision medicine, some cancers still have alarmingly high prevalence and devastatingly poor survival rates[1]. Why?
The answer stems in part from what historically could not be seen. Despite decades of technological innovation, the most critical clinical gap has been the inability to see what’s happening inside the body, in real time, at the cellular level. This has left physicians standing at the crossroads of guesswork and action, relying on traditional methods that involve imprecise tissue acquisition, prolonged processing, and inconclusive analysis. All of this unfolds while life-altering decisions hang in the balance for both patients and providers.
The stark reality is: technology has advanced, but not always in the places that matter most. And for cancers like pancreatic, esophageal, and lung, where precision and early detection is often the difference between life and death, the inability to distinguish benign from malignant tissue instantly can mean the difference between early intervention and late-stage treatment[2].
To change the dynamic for these life-threatening diseases, physicians need better targeting, better classification capabilities, better risk stratification, and better information in order to make accurate, timely diagnoses that are personalized to each patient. We must equip clinical teams with real-time, cellular-level insights that allow them to act precisely, confidently, and immediately. Not after unnecessary procedures. Not when it’s too late.
At Mauna Kea Technologies, we believe it’s time to eliminate diagnostic uncertainty because patients deserve better. That’s why our Cellvizio platform was designed to transform how physicians approach diagnosis and treatment across gastroenterology and pulmonology by delivering unprecedented in vivo cellular visualization capabilities directly to the point of care.
Breaking Down Clinical Barriers with a Novel Technology
Unlike any other technology in the world, Cellvizio uses Confocal Laser Endomicroscopy (CLE) to give physicians a real-time, microscopic view of tissues at the cellular level during procedures, directly inside the body, and with magnification up to 1000x. This unique platform’s impact extends far beyond simple visualization. By providing deep observation of mucosal tissues and cellular architecture through the course of a procedure, Cellvizio enables physicians to make informed decisions instantly during challenging cases. When incorporated into existing procedures, clinicians can examine areas of concern and visualize cellular structures, fundamentally transforming their approach to diagnosis and treatment.
Adapting to Real-World Demands
The next-generation Cellvizio platform has been meticulously designed with enhanced capabilities that push the boundaries of interventional medicine. It’s especially valuable in areas like pancreatic cyst evaluation, where traditional diagnostic techniques often yield poor accuracy and leave questions unanswered[3]. With a compact design and easy integration into existing workflows, Cellvizio fits seamlessly into existing endoscopy procedure protocols as an adjunct, enhancing the effectiveness of the procedure.
The platform features a touchscreen interface and single-handed probe connection for quick integration into existing procedures. Picture-in-Picture (PiP) functionality allows physicians to view endoscopic images and cellular-level visualization simultaneously, maintaining complete procedural awareness. DICOM (Digital Imaging and Communications in Medicine) compatibility enables direct patient data retrieval and archiving, allowing clinical teams to seamlessly integrate findings into electronic medical records for care team collaboration, which is essential for cancer patients.
Cellvizio pushes the boundaries of interventional medicine, and creates the unique opportunity to accelerate diagnosis, inform treatment, and improve therapy in the diagnosis and care of various diseases and cancers like never before.
Cellvizio’s specialized probes support a wide range of clinical needs, from pancreatic cysts to esophageal and lung lesions. Its flexibility enables targeted, real-time cellular analysis at the point of care, helping physicians move to immediate evidence-based decisions. The result: earlier detection, more precise treatments, fewer repeat procedures, and lower healthcare costs[4], yielding better outcomes and higher satisfaction scores for patients 7.
Advancing Cross-Specialty Innovation to Broaden New Possibilities in Healthcare Solutions
Cellvizio’s versatility is creating exciting new possibilities across diverse medical specialties, each benefiting from the unique advantages of real-time cellular visualization.
Gastroenterology: Pancreatic Cysts. With Cellvizio, physicians can examine cellular architecture directly, enabling more confident treatment decisions and reducing the frequency of indeterminate pancreatic cysts which can lead to unnecessary surgical interventions. For example, most pancreatic cystic lesions are discovered through incidental imaging requiring classification and risk stratification, and yet achieving a definitive diagnosis is particularly difficult even with an EUS-FNA procedure. Incorporating Cellvizio significantly improves sensitivity, specificity, and diagnostic accuracy from 74%, 90%, and 81% to 98%, 95%, and 97%, respectively[5].
Gastroenterology: Barrett’s Esophagus and Esophageal Cancer. The prevalence of esophageal adenocarcinoma (EAC) continues to rise, which is counter-intuitive given the improvement in endoscopes and initiation of screening programs. The issue comes down to a fundamental problem: Existing diagnostic techniques are inherently poor and often prone to sampling error. By using Cellvizio to identify areas of concern and to target biopsies, physicians have reported a 243% improvement in neoplasia detection[6], and a 20% reduction in the number of procedures[7] needed for endoscopic eradication therapy (EET).
Pulmonology: Advancing Respiratory Medicine. Cellvizio represents a breakthrough for the detection, diagnosis, and treatment of a wide range of pulmonary diseases. It is shown that accurate sampling of lung nodules is challenging not only because of their location outside the airway but also because of intratumor heterogeneity, even in early cancer[8]. The platform’s confocal miniprobes can be deployed through standard or robotic bronchoscopic procedures, allowing pulmonologists to reliably access the lesion through the airway wall and confirm obtaining a sample without requiring additional procedures. The technology’s ability to visualize cellular structures has also proven particularly valuable in understanding complex respiratory conditions or confirming acceptance or rejection of a lung transplant. This capability is transforming how physicians approach conditions ranging from lung cancer screening to inflammatory lung diseases, providing immediate information that can guide treatment decisions in real time.
Beyond the Procedure
The clinical implications of real-time cellular visualization extend far beyond individual procedures, creating a cascade of improvements throughout patient care. Where robotic and advanced imaging devices struggle to navigate environments they can’t ‘see’ through, Cellvizio provides the essential ‘vision’ needed for more precise and less invasive procedures, such as evaluating lesions in the periphery. This enhanced visualization capability is revolutionizing diverse medical applications, from functional medicine where physicians can now observe cellular responses to foods in real time to identify intolerances instantly, to complex procedural guidance which reduces the need for repeat interventions.
The technology’s ability to guide treatment decisions in real time may potentially reduce the need for repeat procedures, minimizing patient exposure to procedural risks while improving diagnostic efficiency. For conditions like pancreatic cysts, where traditional approaches often require multiple steps and extended monitoring periods, Cellvizio’s immediate cellular analysis can streamline the diagnostic workflow significantly.
Cellvizio’s real-time capabilities enable physicians to make more confident treatment decisions during procedures, potentially reducing diagnostic uncertainty and improving patient care.
The Future: Setting New Standards for Healthcare Excellence
Cellvizio embodies a fundamental shift toward diagnostic capabilities that were previously unimaginable. By combining extreme clarity of visualization with in vivo information and remarkable flexibility in form and function, the platform is creating new possibilities for medical diagnosis and treatment across multiple specialties.
The evolution of the next-generation Cellvizio platform will incorporate advanced artificial intelligence capabilities for assisted image pattern recognition. This technological advancement represents a significant step forward in diagnostic precision, helping physicians identify subtle cellular changes that might otherwise be overlooked. For example, a recent publication demonstrated that AI-powered image sequence review offers superior accuracy for detecting high-grade dysplasia and invasive adenocarcinoma while eliminating interobserver variability[9].
The technology’s impact on medical practice extends beyond individual procedures to encompass entire care pathways, and as healthcare continues to evolve toward more precise, personalized medicine, technologies like Cellvizio will become increasingly essential. At Mauna Kea Technologies, we’re committed to driving this transformation. When innovation focuses on providing physicians with the tools they need to see beyond the surface, it ultimately results in better care for the patients who need it most.
[1] Hang, Thuy-Van P., et al. “The Epidemiology of Esophageal Adenocarcinoma in the United States: Presidential Poster Award: 333.” The American Journal of Gastroenterology, vol. 113, no. Supplement, Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins, 2018, pp. S185–S186, https://doi.org/10.14309/00000434-201810001-00333.
[2] Singer ME, Odze RD. High rate of missed Barrett’s esophagus when screening with forceps biopsies. Esophagus. 2023 Jan;20(1):143-149. doi: 10.1007/s10388-022-00943-4. Epub 2022 Jul 22. PMID: 35864425; PMCID: PMC9813185.
[3] Krishna SG, Hart PA, Malli A, Kruger AJ, McCarthy ST, El-Dika S, Walker JP, Dillhoff ME, Manilchuk A, Schmidt CR, Pawlik TM, Porter K, Arnold CA, Cruz-Monserrate Z, Conwell DL. Endoscopic Ultrasound-Guided Confocal Laser Endomicroscopy Increases Accuracy of Differentiation of Pancreatic Cystic Lesions. Clin Gastroenterol Hepatol. 2020 Feb;18(2):432-440.e6. doi: 10.1016/j.cgh.2019.06.010. Epub 2019 Jun 18. PMID: 31220640.
[4] Luthra A, et al. Cost-Benefit Analysis and Resource Implications of Endoscopy Ultrasound-guided Confocal Endomicroscopy in Pancreas Cysts, Techniques and Innovations in Gastrointestinal Endoscopy, 2021. https://doi.org/10.1016/j.tige.2021.10.002.
[5] Burlen, Jordan et al. Accuracy of Real-Time EUS-Guided Confocal Laser Endomicroscopy Interpretation for Discerning Specific Types of Pancreatic Cystic Lesions: Insights from a Multicenter Prospective Study. Gastroenterology, Volume 166, Issue 5, S-256 – S-257 DOI: 10.1016/S0016-5085(24)01074-6
[6] DeMeester S. et al. High definition probe-based confocal laser endomicroscopy review and meta-analysis for neoplasia detection in Barrett’s esophagus. Techniques and Innovations in Gastrointestinal Endoscopy, 2022. doi: 10.1016/j.tige.2022.06.001.
[7] Randhawa N, et al. A comparison of patient satisfaction and healthcare resource use in patients with Barrett’s Esophagus using CLE based approach versus standard of care. DDW 2023 Poster. https://eposters.ddw.org/ddw/2023/ddw-2023/377845/navkiran.randhawa.a.comparison.of.patient.satisfaction.and.healthcare.resource.html
[8] Senosain MF, Massion PP. Intratumor Heterogeneity in Early Lung Adenocarcinoma. Front Oncol. 2020;10:349. Published 2020 Mar 17. doi:10.3389/fonc.2020.00349.
[9] Krishna SG, Abdelbaki A, Li Z, Culp S, Xiong X, Napoleon B, Mok S, Bertani H, Feng Y, Kongkam P, Luthra AK, Machicado JD, El-Dika S, Leblanc S, Tan DMY, Burlen J, Keane MG, Keihanian T, Ladd AM, Muniraj T, Visrodia KH, Chen W, Esnakula AK, Hart PA, Chao WL. Towards automating risk stratification of intraductal papillary mucinous Neoplasms: Artificial intelligence advances beyond human expertise with confocal laser endomicroscopy. Pancreatology. 2025 May 21:S1424-3903(25)00107-3. doi: 10.1016/j.pan.2025.05.011. Epub ahead of print. PMID: 40447463.