News & Events

Past Webinar – Unlocking Success: FDA Regulatory Strategies for AgeTech Devices and AI

https://www.youtube.com/watch?v=0dpRR_cDPPs Abstract:  This webinar explores regulatory strategies for bringing AgeTech devices and AI innovations to market under FDA oversight. Panelists provided an overview of FDA pathways, including 510(k), De Novo, and Pre-Market Approval (PMA), highlighting how device classification and intended use shape regulatory requirements. Discussion emphasized unique challenges for software as a medical device (SaMD), clinical decision support (CDS) tools, and AI/ML-enabled technologies, including validation standards and cybersecurity mandates. Speakers underscored the importance of aligning regulatory strategy with business models and offered guidance on leveraging Pre-Submission processes and breakthrough device designation to accelerate approval. Real-world insights from wearable device development illustrated the complexities of clinical validation, reimbursement planning, and risk-based regulation.You will gain practical knowledge on navigating FDA processes to responsibly develop and deploy AgeTech innovations for older adults. About the Speakers:  Ameet Sarpatwari, PhD,…

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Publication: Oscillometric blood pressure measurements on smartphones using vibrometric force estimation

Authors: Colin Barry, Yinan Xuan, Ava Fascetti, Alison Moore, Edward J Wang Abstract This paper proposes a smartphone-based method for measuring Blood Pressure (BP) using the oscillometric method. For oscillometry, it is necessary to measure (1) the pressure applied to the artery and (2) the local blood volume change. This is accomplished by performing an oscillometric measurement at the finger's digital artery, whereby a user presses down on the phone's camera with steadily increasing force. The camera is used to capture the blood volume change using photoplethysmography. We devised a novel method for measuring the force applied of the finger without the use of specialized smartphone hardware with a technique called Vibrometric Force Estimation (VFE). The fundamental concept of VFE relies on a phenomenon where a vibrating object is dampened when an external force is…

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Oral Presentation: NIA workshop – Leveraging Adaptive Technology (“Just-in-Time”) Interventions for Aging and Alzheimer’s Disease and Alzheimer’s Disease-related Dementias

Dr. Inbal Billie Nahum-Shani (PI) presented work from this pilot project during a talk titled "Adaptive interventions and JITAIs as decision policies: What and why?" as part of Session 1 - Digital adaptive interventions: decision-focused evidence production held on October 16, 2024. Source: NIA Event Page

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Oral Presentation: Replicable Bandits for Digital Health

Abstract: Adaptive treatment assignment algorithms, such as bandit and reinforcement learning algorithms, are increasingly used in digital health interventions. Between implementation of the digital health intervention, data analyses are critical for producing generalizable knowledge and deciding how to update the intervention for the next implementation. However the replicability of these between-implementation data analyses has received relatively little attention. This work investigates the replicability of statistical analyses from data collected by adaptive treatment assignment algorithms. We demonstrate that many standard statistical estimators can be inconsistent and fail to be replicable across repetitions of the clinical trial, even as the sample size grows large. We show that this non-replicability is intimately related to properties of the adaptive algorithm itself. We introduce a formal definition of a 'replicable bandit algorithm' and prove that under such algorithms, a wide variety of common statistical analyses are guaranteed to be consistent.…

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Oral Presentation: Wearable device integration of diagnostic sensors and bioelectronic therapeutics for the treatment of neurophysiological conditions

At the International Summit on Sensors and Sensing Technology (ISSST) 2024 in Edinburgh, UK Source: https://www.spectrumconferences.com/2024/issst#sessions

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Publication: Development of a One Dollar Blood Pressure Monitor

Authors: Yinan Xuan, Ava J. Fascetti, Colin Barry, Edward J. Wang Abstract BPClip is an ultra-low-cost cuffless blood pressure monitor. As a universal smartphone attachment, BPClip leverages the computational imaging power of smartphones to perform oscillometry based blood pressure measurements. This paper examines different design considerations in BPClip's development. The cost and accuracy of blood pressure measurements are the central design goals. Both requirements are achieved with the initial prototype that achieves a 0.80 USD material cost and a mean absolute error of 8.72 and 5.49 mmHg for systolic and diastolic blood pressure, respectively. Since a main motivator to develop BPClip is making blood pressure monitoring more accessible, usability is also central to the design. User studies were conducted throughout the design process to inform the most intuitive and accessible design features. In this paper,…

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Publication: ACM 2024 Conference Proceeds – Development of a One Dollar Blood Pressure Monitor

Authors: Yinan Xuan, Ava J. Fascetti, Colin Barry, Edward J. Wang Abstract BPClip is an ultra-low-cost cuffless blood pressure monitor. As a universal smartphone attachment, BPClip leverages the computational imaging power of smartphones to perform oscillometry based blood pressure measurements. This paper examines different design considerations in BPClip's development. The cost and accuracy of blood pressure measurements are the central design goals. Both requirements are achieved with the initial prototype that achieves a 0.80 USD material cost and a mean absolute error of 8.72 and 5.49 mmHg for systolic and diastolic blood pressure, respectively. Since a main motivator to develop BPClip is making blood pressure monitoring more accessible, usability is also central to the design. User studies were conducted throughout the design process to inform the most intuitive and accessible design features. In this paper,…

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