Is PinnacleAI an approved medical device?

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 — a clinical AbilityScore® and any diagnosis are formed only at a Pinnacle Blooms Network centre under qualified clinician care.

Explore more: How the AbilityScore® works · Book a free developmental assessment