Jay Nayar

Jay Nayar

Jay is a Staff Regulatory Affairs Specialist at Google. His focus is on providing guidance related to the unique regulatory and security landscape within which innovative solutions are developed to face the challenges in healthcare. His responsibilities at prior positions included regulatory, security, and quality system management of platform-based software devices (SaMD and SiMD), artificial intelligence-based devices, combination devices, and endoscopic devices. Jay has a Masters in Medical Device and Diagnostics Engineering from the University of Southern California as well as certifications from the Regulatory Affairs Professionals Society (RAPS).
Authored Publications
Sort By
  • Title
  • Title, descending
  • Year
  • Year, descending
    Performance of a Deep Learning Diabetic Retinopathy Algorithm in India
    Arthur Brant
    Xiang Yin
    Lu Yang
    Divleen Jeji
    Sunny Virmani
    Anchintha Meenu
    Naresh Babu Kannan
    Florence Thng
    Lily Peng
    Ramasamy Kim
    JAMA Network Open (2025)
    Preview abstract Importance: While prospective studies have investigated the accuracy of artificial intelligence (AI) for detection of diabetic retinopathy (DR) and diabetic macular edema (DME), to date, little published data exist on the clinical performance of these algorithms. Objective: To evaluate the clinical performance of an automated retinal disease assessment (ARDA) algorithm in the postdeployment setting at Aravind Eye Hospital in India. Design, Setting, and Participants: This cross-sectional analysis involved an approximate 1% sample of fundus photographs from patients screened using ARDA. Images were graded via adjudication by US ophthalmologists for DR and DME, and ARDA’s output was compared against the adjudicated grades at 45 sites in Southern India. Patients were randomly selected between January 1, 2019, and July 31, 2023. Main Outcomes and Measures: Primary analyses were the sensitivity and specificity of ARDA for severe nonproliferative DR (NPDR) or proliferative DR (PDR). Secondary analyses focused on sensitivity and specificity for sight-threatening DR (STDR) (DME or severe NPDR or PDR). Results: Among the 4537 patients with 4537 images with adjudicated grades, mean (SD) age was 55.2 (11.9) years and 2272 (50.1%) were male. Among the 3941 patients with gradable photographs, 683 (17.3%) had any DR, 146 (3.7%) had severe NPDR or PDR, 109 (2.8%) had PDR, and 398 (10.1%) had STDR. ARDA’s sensitivity and specificity for severe NPDR or PDR were 97.0% (95% CI, 92.6%-99.2%) and 96.4% (95% CI, 95.7%-97.0%), respectively. Positive predictive value (PPV) was 50.7% and negative predictive value (NPV) was 99.9%. The clinically important miss rate for severe NPDR or PDR was 0% (eg, some patients with severe NPDR or PDR were interpreted as having moderate DR and referred to clinic). ARDA’s sensitivity for STDR was 95.9% (95% CI, 93.0%-97.4%) and specificity was 94.9% (95% CI, 94.1%-95.7%); PPV and NPV were 67.9% and 99.5%, respectively. Conclusions and Relevance: In this cross-sectional study investigating the clinical performance of ARDA, sensitivity and specificity for severe NPDR and PDR exceeded 96% and caught 100% of patients with severe  NPDR and PDR for ophthalmology referral. This preliminary large-scale postmarketing report of the performance of ARDA after screening 600 000 patients in India underscores the importance of monitoring and publication an algorithm's clinical performance, consistent with recommendations by regulatory bodies. View details
    Preview abstract Background Skin conditions are extremely common worldwide, and are an important cause of both anxiety and morbidity. Since the advent of the internet, individuals have used text-based search (eg, “red rash on arm”) to learn more about concerns on their skin, but this process is often hindered by the inability to accurately describe the lesion’s morphology. In the study, we surveyed respondents’ experiences with an image-based search, compared to the traditional text-based search experience. Methods An internet-based survey was conducted to evaluate the experience of text-based vs image-based search for skin conditions. We recruited respondents from an existing cohort of volunteers in a commercial survey panel; survey respondents that met inclusion/exclusion criteria, including willingness to take photos of a visible concern on their body, were enrolled. Respondents were asked to use the Google mobile app to conduct both regular text-based search (Google Search) and image-based search (Google Lens) for their concern, with the order of text vs. image search randomized. Satisfaction for each search experience along six different dimensions were recorded and compared, and respondents’ preferences for the different search types along these same six dimensions were recorded. Results 372 respondents were enrolled in the study, with 44% self-identifying as women, 86% as White and 41% over age 45. The rate of respondents who were at least moderately familiar with searching for skin conditions using text-based search versus image-based search were 81.5% and 63.5%, respectively. After using both search modalities, respondents were highly satisfied with both image-based and text-based search, with >90% at least somewhat satisfied in each dimension and no significant differences seen between text-based and image-based search when examining the responses on an absolute scale per search modality. When asked to directly rate their preferences in a comparative way, survey respondents preferred image-based search over text-based search in 5 out of 6 dimensions, with an absolute 9.9% more preferring image-based search over text-based search overall (p=0.004). 82.5% (95% CI 78.2 - 86.3) reported a preference to leverage image-based search (alone or in combination with text-based search) in future searches. Of those who would prefer to use a combination of both, 64% indicated they would like to start with image-based search, indicating that image-based search may be the preferred entry point for skin-related searches. Conclusion Despite being less familiar with image-based search upon study inception, survey respondents generally preferred image-based search to text-based search and overwhelmingly wanted to include this in future searches. These results suggest the potential for image-based search to play a key role in people searching for information regarding skin concerns. View details
    Preview abstract Background: Skin conditions are extremely common worldwide, and are an important cause of both anxiety and morbidity. Since the advent of the internet, individuals have used text-based search (eg, “red rash on arm”) to learn more about concerns on their skin, but this process is often hindered by the inability to accurately describe the lesion’s morphology. In the study, we surveyed respondents’ experiences with an image-based search, compared to the traditional text-based search experience. Methods: An internet-based survey was conducted to evaluate the experience of text-based vs image-based search for skin conditions. We recruited respondents from an existing cohort of volunteers in a commercial survey panel; survey respondents that met inclusion/exclusion criteria, including willingness to take photos of a visible concern on their body, were enrolled. Respondents were asked to use the Google mobile app to conduct both regular text-based search (Google Search) and image-based search (Google Lens) for their concern, with the order of text vs. image search randomized. Satisfaction for each search experience along six different dimensions were recorded and compared, and respondents’ preferences for the different search types along these same six dimensions were recorded. Results: 372 respondents were enrolled in the study, with 44% self-identifying as women, 86% as White and 41% over age 45. The rate of respondents who were at least moderately familiar with searching for skin conditions using text-based search versus image-based search were 81.5% and 63.5%, respectively. After using both search modalities, respondents were highly satisfied with both image-based and text-based search, with >90% at least somewhat satisfied in each dimension and no significant differences seen between text-based and image-based search when examining the responses on an absolute scale per search modality. When asked to directly rate their preferences in a comparative way, survey respondents preferred image-based search over text-based search in 5 out of 6 dimensions, with an absolute 9.9% more preferring image-based search over text-based search overall (p=0.004). 82.5% (95% CI 78.2 - 86.3) reported a preference to leverage image-based search (alone or in combination with text-based search) in future searches. Of those who would prefer to use a combination of both, 64% indicated they would like to start with image-based search, indicating that image-based search may be the preferred entry point for skin-related searches. Conclusion: Despite being less familiar with image-based search upon study inception, survey respondents generally preferred image-based search to text-based search and overwhelmingly wanted to include this in future searches. These results suggest the potential for image-based search to play a key role in people searching for information regarding skin concerns. View details
    Preview abstract The application of an artificial intelligence (AI)-based screening tool for retinal disease in India and Thailand highlighted the myths and reality of introducing medical AI, which may form a framework for subsequent tools. View details