# Is PinnacleAI an approved medical device?

Canonical: https://pinnacleblooms.org/ask/is-pinnacleai-an-approved-medical-device
Publisher: Pinnacle Blooms Network / Bharath Healthcare Laboratories Private Limited

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.

Trust in a child's development tool should be earned and verifiable. PinnacleAI is.

PinnacleAI'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.

For 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.

PinnacleAI 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.

This is general information, not a diagnosis — individual assessment and diagnosis require an appropriately qualified healthcare professional.

**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)

## Sources
- Source: https://www.who.int

## Connected topics and perspectives
- Parent / Family: https://pinnacleblooms.org/ask/lens/stakeholder/parent
- Definition: https://pinnacleblooms.org/ask/lens/intent/definition
- Screen: https://pinnacleblooms.org/ask/lens/lifecycle/screen
- Book Assessment: https://pinnacleblooms.org/ask/lens/route/book-assessment
- Early Clarity: https://pinnacleblooms.org/ask/lens/empowerment/early_clarity
- English: https://pinnacleblooms.org/ask/lens/language/en
- SDG 3: Good Health and Well-being: https://pinnacleblooms.org/ask/lens/sdg/3
- ASHA / PHC / Frontline: https://pinnacleblooms.org/ask/lens/stakeholder/asha_phc
- Doctor / Pediatrician: https://pinnacleblooms.org/ask/lens/stakeholder/doctor

## Related question paths

### Understand the subject
- What is the clinical and regulatory basis of AbilityScore®?: https://pinnacleblooms.org/ask/what-is-the-clinical-and-regulatory-basis-of-abilityscore

### Explore therapy & support
- How is a developmental-AI tool regulated by CDSCO, FDA and EU MDR?: https://pinnacleblooms.org/ask/how-is-a-developmental-ai-tool-regulated-by-cdsco-fda-and-eu-mdr
- What is Software as a Medical Device (SaMD) in child health?: https://pinnacleblooms.org/ask/what-is-software-as-a-medical-device-samd-in-child-health
- What data powers a child-developmental AI platform?: https://pinnacleblooms.org/ask/what-data-powers-a-child-developmental-ai-platform
- What is TherapeuticAI® at Pinnacle Blooms Network?: https://pinnacleblooms.org/ask/what-is-therapeuticai-at-pinnacle-blooms-network
- How is AI used in child developmental assessment?: https://pinnacleblooms.org/ask/how-is-ai-used-in-child-developmental-assessment