{"product_id":"edan-nano-ob-assist-ai-diagnostic-ultrasound-system","title":"EDAN Nano OB Assist AI Diagnostic Ultrasound System","description":"\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEDAN Nano OB Assist\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAI-enabled handheld ultrasound system purpose-built for prenatal screening\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e in primary care, community health, and low-resource settings. It pairs the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEDAN Nano convex-array transducer\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ededicated AI application\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e that guides users through a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003estandardized six-plane “blind sweep” protocol\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and then automatically calculates key obstetric parameters—\u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003egestational age (GA), estimated due date (EDD), fetal presentation (FP), estimated fetal weight (EFW), and multiple gestation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—without requiring manual caliper placement\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"1\"\u003e\u003ca href=\"https:\/\/dailymashraq.com\/edan-launches-edan-nano-ob-assist-an-ai-enabled-handheld-ultrasound-to-expand-access-to-prenatal-screening-in-africa\/\" rel=\"noreferrer\" aria-label=\"18\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe system is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCE-marked under EU MDR\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (CE marking received \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eMarch 18, 2026\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e), reflecting compliance with European Union safety and performance requirements for its intended use\u003c\/span\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNo FDA 510(k) clearance specific to the “Nano OB Assist” product name was identified in the public FDA database during preparation of this page\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNano C5\/C5 EXP\/L12\/L12 EXP hardware platform\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is FDA-cleared under \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eK251268\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, but the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eOB Assist AI application\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is not separately listed in that clearance\u003c\/span\u003e\u003cspan class=\"\"\u003e. Availability, labeling, and cleared claims vary by market; confirm local registration and intended use before purchase.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"2\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/RA\/subpart-b%E2%80%94diagnostic-devices\/IYN\/K251268?_x_output_type_b6db407c4_=embedded_pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/dailymashraq.com\/edan-launches-edan-nano-ob-assist-an-ai-enabled-handheld-ultrasound-to-expand-access-to-prenatal-screening-in-africa\/\" rel=\"noreferrer\" aria-label=\"18\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNano OB Assist workflow\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is built around \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAI-assisted blind sweep technology\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. An \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eon-screen schematic\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e prompts the user through \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epreparation, followed by a standard six-plane sweep sequence\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eembedded AI\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e then processes the acquired data \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoffline and in real time\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, outputting \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eGA, EDD, FP, EFW, and multiple gestation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e as structured results. This design is intended to \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ereduce reliance on advanced sonographer training\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for basic prenatal measurements, supporting \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efrontline healthcare providers\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e in performing essential screening assessments\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"4\"\u003e\u003ca href=\"https:\/\/dailymashraq.com\/edan-launches-edan-nano-ob-assist-an-ai-enabled-handheld-ultrasound-to-expand-access-to-prenatal-screening-in-africa\/\" rel=\"noreferrer\" aria-label=\"18\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eClinical scope and validation boundaries\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e are explicitly defined: \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eGA calculation is validated for singleton pregnancies with a gestational age between 9 weeks and 37 weeks 6 days\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efetal presentation classification is validated for 28 weeks ≤ GA ≤ 37 weeks 6 days\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The system is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003enot intended for use outside these validated ranges\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and the AI outputs are \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003escreening aids\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—they support the clinician’s assessment and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003edo not constitute a diagnosis\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e or replace clinical judgment.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe hardware is the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEDAN Nano convex-array transducer\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e240 g\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIP67\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e dust\/water resistant, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eup to 5 hours of battery life\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e)\u003c\/span\u003e\u003cspan class=\"\"\u003e. The system connects to an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAndroid tablet or smartphone\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e running the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNano OB Assist application\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. An optional \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003etraditional Nano APP license\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is available for general ultrasound imaging beyond the OB Assist workflow.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"5\"\u003e\u003ca href=\"https:\/\/gyneas.com\/products\/echographe-couleur-portable-edan-nano-convexe\" rel=\"noreferrer\" aria-label=\"8\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe Nano OB Assist is built for \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecommunity health workers, midwives, general practitioners, and primary care clinicians\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e who need \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ea guided, AI-assisted prenatal screening tool\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e that can be deployed in \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eclinics, outreach settings, and mobile care environments\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—expanding access to basic obstetric ultrasound where sonographer expertise is limited.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan class=\"\"\u003eKey Features \u0026amp; Benefits\u003c\/span\u003e\u003c\/h2\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eAI-Guided Blind Sweep Protocol for Standardized Acquisition\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eblind sweep protocol\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e replaces freehand, expertise-dependent scanning with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003estructured, on-screen guided sequence\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The application prompts the user through \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epreparation and a standard six-plane sweep\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, supporting \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003econsistent image acquisition\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e across users with varying ultrasound experience. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAI then processes the sweep data automatically\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, eliminating the need for manual caliper placement and reducing operator-dependent variability\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"6\"\u003e\u003ca href=\"https:\/\/dailymashraq.com\/edan-launches-edan-nano-ob-assist-an-ai-enabled-handheld-ultrasound-to-expand-access-to-prenatal-screening-in-africa\/\" rel=\"noreferrer\" aria-label=\"18\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eAutomated Calculation of GA, EDD, FP, EFW, and Multiple Gestation\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe embedded AI outputs \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efive core obstetric parameters\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e in real time and offline: \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003egestational age\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eestimated due date\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (derived from GA), \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efetal presentation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (cephalic or non-cephalic), \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eestimated fetal weight\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003emultiple gestation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. These outputs are presented as \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003estructured results\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for clinician review. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eValidation boundaries are explicit\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e: GA is validated for \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esingleton pregnancies at 9w–37w6d\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; FP classification is validated for \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e28w–37w6d\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. Results outside these ranges are not within the validated scope of the AI function.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003ePortable, IP67, 5-Hour Battery Hardware\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe Nano convex transducer weighs approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e240 g\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, carries an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIP67\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e rating for dust and water resistance, and provides \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eup to 5 hours of battery operation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. It connects to \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAndroid tablets and smartphones\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e via \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eWi-Fi or cable\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and the system powers on and scans immediately, supporting \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epoint-of-care prenatal screening\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e in clinics, outreach sites, and home visits.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"7\"\u003e\u003ca href=\"https:\/\/gyneas.com\/products\/echographe-couleur-portable-edan-nano-convexe\" rel=\"noreferrer\" aria-label=\"8\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eDesigned for Frontline and Low-Resource Settings\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eEDAN developed the Nano OB Assist specifically to address \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003elimited access to skilled sonographers and complex ultrasound workflows\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e in underserved regions\u003c\/span\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eguided protocol and automated analysis\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e are intended to \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esupport frontline healthcare providers\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—including those without advanced ultrasound training—in performing \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ebasic prenatal assessments\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and making \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003etimely referral decisions\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The system was launched with a regional deployment focus in \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAfrica\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with EDAN establishing local partnerships and training support\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"8\"\u003e\u003ca href=\"https:\/\/dailymashraq.com\/edan-launches-edan-nano-ob-assist-an-ai-enabled-handheld-ultrasound-to-expand-access-to-prenatal-screening-in-africa\/\" rel=\"noreferrer\" aria-label=\"18\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eOffline AI Processing and Immediate On-Device Output\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe AI calculations run \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoffline on the connected Android device\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with results available \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ein real time\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e after the sweep. This design supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003euse in settings with limited or no internet connectivity\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and avoids dependence on cloud processing for core screening outputs.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eOptional General Imaging License\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eAn \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoptional Traditional Nano APP license\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is available, enabling \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003egeneral ultrasound imaging\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e beyond the OB Assist workflow. This allows the same hardware to serve \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eabdominal, gynecological, and other general applications\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e where the clinician requires conventional B-mode imaging.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eRegulatory Status: CE-Marked; AI Application Not Separately FDA-Cleared\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNano OB Assist is CE-marked\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (March 18, 2026) for its intended prenatal screening use\u003c\/span\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNano C5\/C5 EXP\/L12\/L12 EXP hardware platform\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA-cleared under K251268 (Class II, IYN\/IYO\/ITX)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, but the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eOB Assist AI application is not separately listed\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e in that clearance\u003c\/span\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNo independent peer-reviewed clinical validation study specific to the Nano OB Assist was identified in the public literature during preparation of this page.\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e The product is positioned for \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eprenatal screening support\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, not as a diagnostic device.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"11\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/RA\/subpart-b%E2%80%94diagnostic-devices\/IYN\/K251268?_x_output_type_b6db407c4_=embedded_pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/dailymashraq.com\/edan-launches-edan-nano-ob-assist-an-ai-enabled-handheld-ultrasound-to-expand-access-to-prenatal-screening-in-africa\/\" rel=\"noreferrer\" aria-label=\"18\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan class=\"\"\u003eTechnical Specifications\u003c\/span\u003e\u003c\/h2\u003e\n\u003cdiv class=\"ds-scroll-area ds-scroll-area--show-on-focus-within ds-scroll-area--enabled _1210dd7 c03cafe9\"\u003e\n\u003cdiv class=\"ds-scroll-area__gutters\"\u003e\n\u003cdiv class=\"ds-scroll-area__horizontal-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"ds-scroll-area__vertical-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ctable\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eSpecification\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eDetail\u003c\/span\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDevice Type\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eAI-enabled handheld ultrasound system for prenatal screening\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eRegulatory Status\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cstrong\u003e\u003cspan class=\"\"\u003eCE-marked (March 18, 2026)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e ; \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNano OB Assist AI application not separately listed in FDA K251268\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (hardware platform Nano C5\/C5 EXP\/L12\/L12 EXP is FDA-cleared); confirm local registration and intended use\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAI Function\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eBlind sweep protocol; automated GA, EDD, FP, EFW, multiple gestation\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eValidated GA Range\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSingleton pregnancies, 9 weeks to 37 weeks 6 days\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eValidated FP Range\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cstrong\u003e\u003cspan class=\"\"\u003e28 weeks to 37 weeks 6 days\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (cephalic vs. non-cephalic)\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eTransducer\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eConvex array; approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e240 g\u003c\/span\u003e\u003c\/strong\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIngress Protection\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cstrong\u003e\u003cspan class=\"\"\u003eIP67\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (dust and water resistant)\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eBattery\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eUp to \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e5 hours\u003c\/span\u003e\u003c\/strong\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eConnectivity\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eAndroid tablet\/smartphone; \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eWi-Fi or cable\u003c\/span\u003e\u003c\/strong\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAI Processing\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cstrong\u003e\u003cspan class=\"\"\u003eOffline, real-time\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e on connected Android device\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eOptional License\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eTraditional Nano APP (general imaging)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIntended Use\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003ePrenatal screening in hospitals, clinics, or home settings by qualified healthcare professionals; \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAI outputs are screening aids, not diagnostic conclusions\u003c\/span\u003e\u003c\/strong\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eClinical Evidence\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cstrong\u003e\u003cspan class=\"\"\u003eNo independent peer-reviewed validation study specific to Nano OB Assist identified\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; validation boundaries defined by device labeling\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e\n\u003ch2\u003e\u003cspan class=\"\"\u003eWhy Choose the EDAN Nano OB Assist?\u003c\/span\u003e\u003c\/h2\u003e\n\u003cdiv class=\"ds-scroll-area ds-scroll-area--show-on-focus-within ds-scroll-area--enabled _1210dd7 c03cafe9\"\u003e\n\u003cdiv class=\"ds-scroll-area__gutters\"\u003e\n\u003cdiv class=\"ds-scroll-area__horizontal-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"ds-scroll-area__vertical-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ctable\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eClinical or Operational Challenge\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eNano OB Assist Solution\u003c\/span\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed basic prenatal screening in settings without trained sonographers\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eAI-guided blind sweep protocol with on-screen prompts; automated GA, EDD, FP, EFW, and multiple gestation calculation\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed a portable device for outreach and low-resource environments\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e240 g convex transducer; IP67; 5-hour battery; Android tablet\/smartphone connectivity\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed standardized, operator-independent acquisition\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eStructured six-plane sweep sequence with AI processing; reduces reliance on freehand technique\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed offline operation without internet dependence\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eAI runs locally on the Android device; results available in real time\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed clear validation boundaries for clinical use\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eGA validated 9w–37w6d; FP validated 28w–37w6d; outside-range use is not within the AI’s validated scope\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed regulatory documentation for procurement\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eCE-marked for prenatal screening use; hardware platform FDA-cleared (K251268); confirm local market access\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e","brand":"Global Healthcare Medical","offers":[{"title":"Default Title","offer_id":46576286695468,"sku":null,"price":1899.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/NanoOBAssistDiagnosticUltrasoundSystem.png?v=1793762905","url":"https:\/\/www.globalhealthcaremedical.com\/products\/edan-nano-ob-assist-ai-diagnostic-ultrasound-system","provider":"Global Healthcare Medical","version":"1.0","type":"link"}