{"h1":"Is PinnacleAI an approved medical device?","faq":[],"lang":"en","slug":"is-pinnacleai-an-approved-medical-device","title":"Is PinnacleAI an approved medical device?","entity":{"key":"sys_samd","kind":"system","name":"PinnacleAI","slug":"is-pinnacleai-an-approved-medical-device"},"lenses":[{"kind":"stakeholder","label":"Parent / Family","value":"parent"},{"kind":"intent","label":"Definition","value":"definition"},{"kind":"lifecycle","label":"Screen","value":"screen"},{"kind":"route","label":"Book-Assessment","value":"book-assessment"},{"kind":"empowerment","label":"Early Clarity","value":"early_clarity"},{"kind":"language","label":"English","value":"en"},{"kind":"sdg","label":"SDG 3: Good Health and Well-being","value":"3"},{"kind":"stakeholder","label":"ASHA / PHC / Frontline","value":"asha_phc"},{"kind":"stakeholder","label":"Doctor / Pediatrician","value":"doctor"}],"parent":null,"related":[{"lang":"en","slug":"what-is-software-as-a-medical-device-samd-in-child-health","title":"What is Software as a Medical Device (SaMD) in child health?"},{"lang":"en","slug":"how-is-a-developmental-ai-tool-regulated-by-cdsco-fda-and-eu-mdr","title":"How is a developmental-AI tool regulated by CDSCO, FDA and EU MDR?"},{"lang":"en","slug":"how-is-ai-used-in-child-developmental-assessment","title":"How is AI used in child developmental assessment?"},{"lang":"en","slug":"what-data-powers-a-child-developmental-ai-platform","title":"What data powers a child-developmental AI platform?"},{"lang":"en","slug":"what-is-therapeuticai-at-pinnacle-blooms-network","title":"What is TherapeuticAI® at Pinnacle Blooms Network?"},{"lang":"en","slug":"what-is-the-clinical-and-regulatory-basis-of-abilityscore","title":"What is the clinical and regulatory basis of AbilityScore®?"}],"summary":"PinnacleAI's developmental-support software is regulated as a Software as a Medical Device (SaMD), classified Class B by India's CDSCO — a mark of clinical-grade governance behind the platform families use.","answer_md":"Trust in a child's development tool should be earned and verifiable. PinnacleAI is.\n\nPinnacleAI's developmental-support software is regulated as a **Software as a Medical Device (SaMD)** and carries a **Class B classification from India's Central Drugs Standard Control Organisation (CDSCO)** — the national medical-device regulator. That places the platform under formal clinical-grade quality, safety and governance standards, not the looser bar of a general wellness app.\n\nFor a family this matters in practical terms: the tools their clinician uses are built and maintained to a regulated standard, with documented quality management and oversight. It is part of why Pinnacle Blooms Network® can stand behind both the science and the safety of what it offers.\n\nPinnacleAI supports clinicians and families with developmental measurement, planning and education. A clinical diagnosis and a clinical AbilityScore® are always formed by qualified professionals at a Pinnacle centre — the regulated software supports that work, it does not replace the clinician.\n\nThis is general information, not a diagnosis — individual assessment and diagnosis require an appropriately qualified healthcare professional.\n\n**Explore more:** [How the AbilityScore® works](/ask/what-is-the-abilityscore-and-how-is-it-calculated) · [Book a free developmental assessment](https://www.pinnacleblooms.org/enroll-autism-speech-aba-therapies-india)","canonical":"https://pinnacleblooms.org/ask/is-pinnacleai-an-approved-medical-device","editorial":{"reviewed_at":"2026-06-10T01:31:34.460066+00:00","reviewed_by":"VII","developed_by":"SETU Consortium · Pinnacle Blooms Network"},"alternates":[{"href":"https://pinnacleblooms.org/ask/is-pinnacleai-an-approved-medical-device","lang":"en","indexable":true},{"href":"https://pinnacleblooms.org/ask/is-pinnacleai-an-approved-medical-device-te","lang":"te","indexable":false}],"dimensions":[],"meta_title":"Is PinnacleAI an approved medical device?","meta_robots":"index, follow, max-image-preview:large","everyday_tip":null,"published_at":"2026-06-10T01:31:34.460066+00:00","reading_paths":[{"key":"understand","items":[{"lang":"en","slug":"what-is-the-clinical-and-regulatory-basis-of-abilityscore","title":"What is the clinical and regulatory basis of AbilityScore®?","reason":"Linked from this answer"}],"label":"Understand the subject","total":1},{"key":"therapy","items":[{"lang":"en","slug":"how-is-a-developmental-ai-tool-regulated-by-cdsco-fda-and-eu-mdr","title":"How is a developmental-AI tool regulated by CDSCO, FDA and EU MDR?","reason":"Linked from this answer"},{"lang":"en","slug":"what-is-software-as-a-medical-device-samd-in-child-health","title":"What is Software as a Medical Device (SaMD) in child health?","reason":"Linked from this answer"},{"lang":"en","slug":"what-data-powers-a-child-developmental-ai-platform","title":"What data powers a child-developmental AI platform?","reason":"Linked from this answer"},{"lang":"en","slug":"what-is-therapeuticai-at-pinnacle-blooms-network","title":"What is TherapeuticAI® at Pinnacle Blooms Network?","reason":"Linked from this answer"},{"lang":"en","slug":"how-is-ai-used-in-child-developmental-assessment","title":"How is AI used in child developmental assessment?","reason":"Linked from this answer"}],"label":"Explore therapy & support","total":5}],"what_to_watch":null,"authority_links":[{"url":"https://www.who.int","tier":1,"source":"who","display":"WHO — Software as a Medical Device (SaMD) framework"}],"last_reviewed_at":"2026-06-10T10:03:12.170172+00:00","meta_description":"PinnacleAI's developmental-support software is regulated as a Software as a Medical Device (SaMD), classified Class B by India's CDSCO — a mark of clinical-grade governance behind the platform families use.","related_materials":[],"related_techniques":[]}