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A Novel AI Powered Objective Pain Quantifying Software as a Medical Device
Shariff, Mohammad Naveed, LEE, JIEUN , Yerrapragada, Gayathri, Elangovan, Poonguzhali, Janarthanan, Jayarajasekaran, Richard, Samuel, Mitra, Dipankar , Sood, Divyanshi, Iyer, Vivek N., Arunachalam, S., Arunachalam, S P , Shariff, Mohammed Naveed , Yerrapragada, Gayathri, Elangovan, Poonguzhali , Natarajan, Thangeswaran, Helgeson, Scott A. , Arunachalam, Shivaram P.

2026 Design of Medical Devices Conference | June 4, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1115/dmd2026-1045 Get It

Abstract Pain assessment plays a critical role in clinical decision-making, yet conventional methods rely heavily on subjective self-reports such as the Visual Analog Scale (VAS) or the Numeric Rating Scale (NRS). These approaches fail in scenarios involving infants, sedated patients, unconscious individuals, or those with cognitive or communication impairments. To address this gap, this research proposes PainNet, an AI-driven, real-time facial pain recognition system that integrates deep learning-based object detection with Action Unit (AU)–based pain intensity scoring. The system uses YOLOv8 for rapid facial expression detection and incorporates Py-Feat to extract pain-relevant AUs, enabling computation of the Prkachin and Solomon Pain Intensity (PSPI) score. A balanced dataset comprising 500 images sourced from Delaware, BioVid, and RaFD was curated, annotated, and preprocessed for training. The YOLOv8-based binary pain vs. no-pain classifier achieved a mean Average Precision (mAP) of 0.89 and an F1-score of 0.80 on the test dataset, demonstrating strong performance in diverse environments and facial variations. The design emphasizes computational efficiency by activating AU analysis only when YOLOv8 detects probable pain, making PainNet suitable for continuous monitoring in ICUs, elder-care facilities, and telemedicine systems. This study demonstrates that the fusion of real-time object detection and clinically validated AU scoring can significantly advance automated, objective, and scalable pain assessment.
A Novel you only Listen once (YOLO) Deep Learning Model for Interstitial Lung Disease (ILD) Detection using Digital Lung Sound Auscultation: A Feasibility Study
LEE, JIEUN , Yerrapragada, Gayathri, Shariff, Mohammad Naveed, Ibrahim, Mohamed I. , Khalifa, H. Ezzat , Handral, Megha Sasidhar, Cherukuri, Swathi Priya , Kaur, Avneet , Sood, Divyanshi, IYER, VIVEK N, Arunachalam, S., Arunachalam, S P , Yerrapragada, Gayathri, Shariff, Mohammed Naveed , Helgeson, Scott A. , Arunachalam, Shivaram P.

2026 Design of Medical Devices Conference | June 4, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1115/dmd2026-1043 Get It

Abstract Interstitial lung disease (ILD) is a chronic, irreversible condition that is challenging to diagnose due to subtle symptoms and limitations of conventional tools. Noninvasive lung sound analysis using phonopulmography offers a promising alternative. This study evaluated the feasibility of a deep learning model for distinguishing normal and pathological lung sounds in ILD. Lung sound recordings were collected from 12 subjects (6 healthy, 6 ILD) and segmented beat-to-beat using simultaneously acquired ECG and phonopulmography, yielding 2,280 segments. Mel-frequency cepstral coefficients (MFCCs; 13 per segment) were extracted, and a one-dimensional CNN-based You Only Listen Once (YOLO) model was trained for segment classification. Evaluation used Leave-One-Out Cross-Validation, with patient-level classification by aggregating segment predictions via majority vote. On the test set (190 segments per class), the model achieved an average segment-level accuracy of 0.738 ± 0.087 and mean AUC of 0.850 ± 0.062. Precision, recall, and F1-score were 0.775 ± 0.148, 0.755 ± 0.183, and 0.738 ± 0.089, respectively. These preliminary results suggest that beat-level MFCCs with a 1D CNN-based YOLO model enable accurate segment- and patient-level classification. This feasibility study highlights the potential of AI-assisted auscultation for noninvasive monitoring and clinical decision support in ILD management, pending further validation in larger cohorts.
Hemodynamic Simulation of Brain Arteriovenous Malformation (AVM)
Alsereidi, F, Ueki, Yasuhito , Kadirvel, Ram , Le, Trung B., Nguyen, Thien-Tam, Alsereidi, Fatmah R. , Kadirvel, Ramanathan

2026 Design of Medical Devices Conference | June 4, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1115/dmd2026-1028 Get It

Abstract Brain arteriovenous malformations (AVMs) result from abnormal growth of vascular structures. AVMs pose a significant rupture risk, and its treatment is challenging due to the complex hemodynamics within the tangled nidus. Currently, investigating AVM hemodynamics remains a challenge due to the low resolution of clinical imaging modalities. In this study, a high-fidelity Computational Fluid Dynamics (CFD) simulation of a brain AVM from a KRAS-mutated mouse model is developed from micro-CT images. Brain AVMs were induced in mice through systemic delivery of AAV-BR1-CAG vector encoding KRASG12V-GFP transgene to cerebral endothelial cells. High-resolution microCT imaging at 6.551 𝜇𝑚 pixel size captured the complex vascular anatomy. The cerebral arteries were reconstructed using the 3D Slicer and Blender software. The curvilinear immersed boundary (CURVIB) method was employed with approximately 65 million grid points and spatial resolution of 0.7−2.3 𝜇𝑚. Our preliminary results reveal heterogeneous flow distribution through the nidus, with blood channeling through two primary pathways. The extremely low Reynolds number (0.038) indicates viscous-dominated flow characteristic of microcirculation. Our work presents the first high-resolution CFD simulation of brain AVM in the literature, providing a foundation for investigating flow-mediated vascular remodeling, rupture risk assessment, and therapeutic intervention planning in future.
Mi-VAD - A Novel Supra-Valvular Cardiac Assist System Transitioning From Apical Cannulation
Kushwaha, S, Verkaik, Josiah, Khalpey, Zain, Joyce, Lyle D., Joyce, David, Yacoub, Magdi H., Griffiths, Leigh, Arunachalam, S., Antaki, James, Arunachalam, S P , Verkaik, Josiah E., Khalpey, Zain, Yacoub, Magdi Habib , Arunachalam, Shivaram P.

2026 Design of Medical Devices Conference | June 4, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1115/dmd2026-1073 Get It

Abstract Heart failure (HF) is a major cause of hospitalization and mortality worldwide. Ventricular assist devices (VADs) represent an alternative to cardiac transplantation for advanced HF. The main FDA-approved VAD (HeartMate III, Abbott), while effective, requires major cardiac surgery to insert the inflow cannula into the cardiac apex, and is associated with numerous co-morbidities and re-hospitalizations related to continuous flow and an external drive line and power supply. Mi-VAD, Inc. aspires to improve outcomes and quality of life with a miniature, minimally invasive, pulsatile, transcutaneously-powered VAD that is implanted above the aortic valve and/or the pulmonary valve and offering a wide range of hemodynamic support suitable for both advanced-stage and less advanced HF. Through its unique placement, there is the potential for right ventricular and biventricular cardiac assist for patients with restrictive cardiomyopathy and HFpEF for whom current VAD therapy is ineffective. Mi-VAD, Inc. has achieved proof of concept with its prototype, providing pulsatile ECG gated cardiac assist up to 10L/minute. Following initial bench top performance testing and in vivo efficacy and safety studies future work will focus on the development of wireless charging capability and conducting GLP builds for verification, regulatory clearance and commercialization. Additional technical development will focus on AI-driven hemodynamic optimization using multimodal physiologic sensing towards patient-specific digital twin of the Mi-VAD platform.
AI-Powered Ejection Fraction Estimation Through Cardiac Electromechanical Fingerprinting (CEMF): Feasibility Study
Wilson, Sancia Mary Jerold, LEE, JIEUN , Yerrapragada, Gayathri, Shariff, Mohammad Naveed, Shivaram, Srishiwin, Valluri, Sai Vibhav, Shivaram, Kriszwin, Sood, Divyanshi, IYER, VIVEK N, Kushwaha, S, Arunachalam, S., Arunachalam, S P , Yerrapragada, Gayathri, Shariff, Mohammed Naveed , Helgeson, Scott A. , Arunachalam, Shivaram P.

2026 Design of Medical Devices Conference | June 4, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1115/dmd2026-1044 Get It

Abstract Accurate assessment of left-ventricular ejection fraction (EF) is a critical metric in diagnosing and managing heart failure; however, methods of assessment remain resource intensive, not widely available in low-acuity or remote settings and are intermittent in nature. This study explores the potential of a novel framework, cardiac electromechanical fingerprinting (cEMF) using synchronized electrocardiography (ECG) and seismocardiography (SCG) collected from a wearable sensing patch as a low-cost, non-invasive, continuous estimate of EF that can be used for rapid point of care screening. A machine learning pipeline was developed to process raw ECG and SCG data to derive EF. Signals were cleaned using band-pass filtering, NeuroKit2-based ECG cleaning and fiducial detection of critical electromechanical events. We extracted an ECG-SCG feature space consisting of heart-rate variability metrics, ECG morphological characterization, SCG timing intervals, spectral and entropy-based features. The top thirty most important features for EF were used to train and evaluate several regressor models. The best performing model was the Gaussian Process Regressor with an MAE of 5.43. Our findings demonstrate the promise of producing clinically relevant cardiac function measures, such as EF, from wearable electromechanical signals. Future work using larger datasets and complementary physiological signals such as phonocardiogram (PCG) may significantly strengthen EF% estimation and other cardiac functions for clinical applicability.
Patterns of Progression and Clinical Outcomes After First Progression in Patients With Primary Plasma Cell Leukemia
Packard, D, Kumar, Shaji K., Dispenzieri, Angela, Kapoor, Prashant , Janda, Guneet , Hellou, Tamer , Dingli, David, Zanwar, Saurabh , Jevremovic, Dragan, Hayman, Suzanne R. , Abdallah, Nadine, Warsame, Rahma, Kourelis, Taxiarchis , Christenson, Lisa, Hobbs, Miriam, Fonder, A., Pak, Karen, Lee, Lee H. , Lin, Yi, Gertz, MA, Gonsalves, Wilson I., Packard, Daniel George , Packard, Daniel G , Leung, Nelson , Cook, Joselle M , Abdallah, Nadine H , Muchtar, E , Kourelis, Taxiarchis V, Go, Ronald S , Siddiqui, Mustaqeem A , Gertz, Morie A , Rajkumar, S Vincent , Kumar, Shaji , Dispenzieri, Angela , Buadi, Francis K. , Dingli, David , Jevremović, Dragan , Leung, Nelson , Cook, Joselle , Abdallah, Nadine , Binder, Moritz , Muchtar, Eli , Warsame, Rahma , Go, Ronald S. , Siddiqui, Mustaqeem , Christenson, Lisa, Hobbs, Miriam, Fonder, Amie , Lee, Lee H., Lin, Yi, Gertz, Morie A. , Rajkumar, S. Vincent , Gonsalves, Wilson I.

American Journal of Hematology | June 4, 2026 | Volume: 101 | Issue: 9 | Pages: 2157-2165

10.1002/ajh.70400 | PMID 42237452 Get It

ABSTRACT Primary plasma cell leukemia (pPCL) is a rare and aggressive plasma cell disorder with inferior outcomes compared with multiple myeloma (MM). However, studies describing outcomes after first progression and subsequent lines of therapy remain limited. We retrospectively analyzed 104 patients with pPCL who progressed after first‐line therapy treated at one comprehensive cancer center between 2006 and 2024. Clinical characteristics, treatments, time to next treatment (TTNT), and overall survival (OS) were assessed using Kaplan–Meier methods. All pPCL patients received novel agent–based induction. At the time of analysis, 63% had died; median OS was 39 months. High‐risk cytogenetics were present in 71%. The median TTNT after first‐line therapy was 10 months. Symptomatic progression occurred in 29% of patients and was associated with significantly inferior subsequent OS (13 vs. 34 months) compared with those experiencing asymptomatic biochemical progression. The TTNT progressively shortened with subsequent lines of therapy (3rd line: 6 months; 4th line: 4 months; 5th line: 3 months). Notable exceptions included pPCL patients with t (11;14) treated with anti‐BCL‐2‐based regimens, who achieved a median TTNT of 13 months. Additionally, 24 patients received anti‐BCMA CAR T‐cell therapy. With a median follow‐up of 21 months, their median TTNT was 32 months. pPCL is characterized by frequent disease progression and diminishing response duration with successive therapeutic lines. Symptomatic progression portends particularly poor outcomes. Anti‐BCL‐2‐based therapy in t (11;14) disease and anti‐BCMA CAR T‐cell therapy appear to provide more durable disease control and represent important advances for the management of progressed pPCL.
A prediction model and risk stratification tool for survival by chemotherapy in invasive micropapillary carcinoma of the breast: a population-based study with external validation
Yang, Yiqi , Xu, Qiuping, Tang, Lin, Wang, Yucai, Cathcart-Rake, Elizabeth J., Xie, Li , Yang, Fang , Wang, Yucai , Cathcart-Rake, Elizabeth

Frontiers in Oncology | June 4, 2026 | Volume: 16 | Issue: No issue available | Pages: No page available

10.3389/fonc.2026.1746971 | PMID 42326317 Get It

Background Invasive micropapillary carcinoma (IMPC) of the breast is associated with a high propensity for lymphovascular invasion and lymph node metastasis. However, whether chemotherapy is associated with improved survival outcomes in these patients remains unclear. Methods This retrospective study analyzed IMPC patients from the SEER database (2010–2018) (n=1,150) and an external validation cohort from Nanjing Drum Tower Hospital (n=199). Propensity score matching assessed chemotherapy’s impact on overall survival (OS) and breast cancer-specific survival (BCSS) in the SEER cohort. A risk stratification model was developed and validated using the external cohort. Results In the SEER cohort, chemotherapy was associated with significantly improved OS (HR = 0.517, 95% CI 0.293-0.910, P = 0.020) but not BCSS. A risk model incorporating marital status, tumor size, subtype, and radiotherapy history identified high- and low-risk groups. Chemotherapy was associated with significantly better OS only for high-risk patients (internal training cohort: HR = 0.577, 95% CI 0.349-0.952, P = 0.029; internal validation cohort: HR = 0.213, 95% CI 0.070-0.647, P = 0.003). External validation consistently confirmed poorer prognosis for high-risk patients (HR = 2.969, 95% CI 1.028-8.571, P = 0.035) and verified the model’s ability to identify patients with differential OS associations with chemotherapy: chemotherapy was associated with better OS in high-risk patients (HR = 0.163, 95% CI 0.031-0.868, P = 0.016), but not in low-risk patients (HR = 0.793, 95% CI 0.153-4.103, P = 0.782). Conclusions Chemotherapy was associated with improved prognosis particularly in high-risk patients with IMPC. However, chemotherapy decisions should be made cautiously for low-risk patients, taking into account a comprehensive assessment of clinical and pathological factors.
Predicting Treatment Response After Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer
Varghese, Chris , Ng, Jyi Cheng , Sassun, Richard, Thiels, Cornelius, Salehinejad, Hojjat , Perry, William R. G., Mathis, Kellie L., Larson, D. W., Larson, David W. , Perry, William , Varghese, Chris , Larson, David W , Cheng, Jyi Ng , Perry, William R , Sassun, Richard , Thiels, Cornelius A. , Mathis, Kellie L.

Annals of Surgery | June 4, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1097/sla.0000000000007058 | PMID 42240534 Get It

Objective: To develop a predictive model for pathological complete response (pCR) after total neoadjuvant therapy (TNT) to inform selection for watch-and-wait (W/W). Summary Background Data: Patient selection for W/W after TNT for locally advanced rectal cancer remains challenging. Methods: An ensemble of tabular foundation models was fine-tuned in adults with clinical stage II or III microsatellite stable primary rectal adenocarcinoma undergoing TNT and total mesorectal excision (TNT+TME) from 2018-2023 to predict pCR, using pre-TNT, post-TNT and pre-TME variables. This model was externally validated on patients having TNT and W/W (TNT+W/W) to predict persistent clinical complete response (pcCR; the absence of local regrowth, distant metastases, or persistent near-cCR). Area under the receiver operator curve (AUROC), area under the precision-recall curve (AUPRC), and Brier score were calculated with 95% confidence intervals (CI). Results: Among 308 patients that underwent TNT+TME (median age 56; 40% female), the model predicted pCR with an AUROC 0.71 (95% CI 0.65-0.77), AUPRC 0.44 (95% CI 0.35-0.57), and was well calibrated with a Brier score of 0.17 (95% CI 0.15-0.20). At external validation in a cohort of 83 patients that are being managed with TNT+W/W (median age 57; 37% female), the model predicted pcCR with an AUROC 0.69 (95% CI 0.57-0.82), AUPRC 0.90 (95% CI 0.82-0.96), and Brier score of 0.30 (95% CI 0.26-0.33), improving to 0.17 with recalibration. Conclusions: This novel predictive model demonstrated good discrimination and calibration for pCR after TNT+TME with utility in TNT+W/W for pcCR after appropriate recalibration, supporting its application for W/W patient selection.
Response to “Photon-Counting CT in Cardiovascular Imaging: From Technical Promise to Clinical Translation”
Williams, James , LaVere, Michael , Leng, Shuai , Young, Phillip M., Rajiah, Prabhakar , Williams, James M , LaVere, Michael , Leng, Shuai , Rajiah, Prabhakar , Young, Phillip M.

Korean Journal of Radiology | June 4, 2026 | Volume: 27 | Issue: 7 | Pages: 695

10.3348/kjr.2026.0625 | PMID 42252997 Get It

Mean Arterial Pressure at Admission Predicts 28-day Mortality in Patients With Severe Alcohol-Associated Hepatitis
Ventura-Cots, Meritxell, Clemente, Ana, Alvarado-Tapias, Edilmar, Ravi, Sujan, Cuyàs, Berta , Tanguy, M, Poca, Maria, Jäger, Marion , Arteel, Gavin E. , Villagrasa, Ares, Aguilar-Amorós, Anna, Argemí, Josepmaria , Abraldes, Juan G., Bosques, Francisco, Brown, R, Garcia-Taso, Guadalupe, Genesca, Juan, Schanbl, Bernd, Mathurin, P., Louvet, Alexander, Lucey, Michael R., Shawcross, Debbie L., Verna, Elisabeth, Dasarathy, S, Tu, Wanzhu, Kamath, Patrick S, Chalasani, Naga P, McClain, Craig J, Szabo, Gyongyi, Tang, Qing, Barton, Bruce, Nagy, Laura E. , Shah, Vijay H, Sanyal, Arun J, Singal, Ashwani K, Soriano, Germà, Rautou, Pierre Emmanuel, Shawcross, Debbie L. , Ventura Cots, Meritxell , Bataller, Ramon A , Shawcross, Debbie Lindsay , Cuyas, Berta , Ventura‐Cots, Meritxell , Alvarado‐Tápias, Edilmar , Ravi, Sujan, Tanguy, Marion , Poca, María , Fernández‐Carrillo, Carlos , Villagrasa, Ares , Abraldeṣ, Juan G. , Genescà, Joan , Mathurin, Philippe , Lucey, Michael R., Gawrieh, Samer , Tu, Wanzhu , Kamath, Patrick S. , Chalasani, Naga , McClain, Craig J. , Tang, Qing , Shah, Vijay H. , Sanyal, Arun J. , Mitchell, Mack , Singal, Ashwani K. , Rautou, Pierre-Emmanuel

Clinical and Translational Gastroenterology | June 4, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.14309/ctg.0000000000001053 | PMID 42235929 Get It

INTRODUCTION: Alcohol-associated hepatitis (AH) is a severe condition with high short-term mortality. Identifying key predictors of poor outcomes is critical for guiding therapeutic strategies. Mean arterial pressure (MAP), a key determinant of tissue perfusion and systemic hemodynamics, may play a pivotal role in prognosis. METHODS: We analyzed a multicenter, prospective cohort of 323 patients hospitalized with AH, with validation in an independent cohort of 290 patients. Survival was evaluated using Kaplan-Meier curves and compared with the log-rank (Mantel-Cox) test. Cox proportional hazards models were used to estimate hazard ratios for mortality, adjusted for Model for end stage liver disease score. Mechanistic insights were explored through assessment of cardiovascular biomarkers. RESULTS: A baseline MAP <80 mm Hg was associated with significantly higher mortality at both 28 days (27.3% vs 8.0%) and 90 days (40.3% vs 15.6%; P < 0.001 for both). This association persisted after adjusting for Model for end stage liver disease score, age, and baseline hepatic encephalopathy. The incidence of infections during follow-up was similar across MAP groups (27.6% vs 22.8%), but acute kidney injury occurred more frequently in the MAP <80 mm Hg group (62% vs 38%, P < 0.001). In the validation cohort, patients with MAP <80 mm Hg also demonstrated significantly lower 28-day transplant-free survival. Although B-type natriuretic peptide and plasma renin levels were altered in patients with AH, they did not correlate with MAP values. DISCUSSION: A baseline MAP <80 mm Hg is an independent predictor of short-term and mid-term mortality in patients with AH. Strategies aimed at restoring hemodynamic stability may improve outcomes in this high-risk population.