MD-3
The application for a manufacturing licence. It is part of the regulatory record, rather than a second approval.
Read Pinnacle’s source recordFAMILY RELEVANCE & GLOBAL CONTEXT
A connected plan.
Evidence in perspective.
A clearer starting point. A connected plan. Progress that matters in everyday life.
Primary-source context reviewed 18 September 2026. Comparisons describe different intended uses and evidence types; they do not rank clinical effectiveness.
THE MEANING BEHIND THE SCALE
2.7 billion+Structured developmental records.
Section link
Structured developmental records.
One child’s journey at a time.
Section linkCompany-reported in the 7 September 2026 handout.
Counting basis: database rows/events · cutoff 17 July 2026.
A developmental journey you can follow.
Session entries, assessment observations, technique ratings and other platform events can preserve a record over time. The practical question is how that history helps the care team review your child’s plan.
Volume describes the size of the record system. Useful decisions also depend on data quality, consistent measurement, appropriate use and professional judgement.
This is not a count of unique children, independent clinical-trial observations or verified AI-training examples. A large count alone does not prove clinical effectiveness.
Why do some Pinnacle sources say 2.5 billion+ and others 2.7 billion+?
The July dossier used a 2.5 billion+ floor and retired earlier 2.7 billion wording. The September handout subsequently reports 2.7 billion+ observed row counts. The source review distinguishes the 2.5 billion floor assertion in limited assurance from the 2.7 billion factual row-count finding under agreed procedures. Those procedures do not provide an assurance opinion.
These are dated measures with different reporting roles. Neither should be described as an audited count of AI-training examples. Restricted practitioner reports are not republished here.
Read Pinnacle’s source recordA DEFINED PURPOSE. TRACEABLE RESPONSIBILITIES.
Understand what each
credential adds.
Section linkAn issued licence defines the software’s intended use. Quality records describe how the system is managed. The BIS schedule connects those processes to a broader set of developmental-support modules.
MD-5 · Class B
Telangana DCA licence MFG/MD/2026/000248 lists PinnacleAI® GPT-OS v1.0.0 for non-diagnostic developmental support, ages 0–12.
Read Pinnacle’s source recordBIS scope schedule
The schedule names software development, deployment and maintenance, plus ability mapping, parent-guided practice, progress correction and readiness modules.
Read Pinnacle’s source recordPARENTS IN THE LICENSED INTENDED USE
Parents are explicitly included in the licensed intended use.
“The software is intended to assist parents, therapists, educators, and caregivers by providing developmental ability measurement, readiness tracking, progress forecasting, and adaptive therapy-plan support for children aged 0–12 years.”
MD-5 MFG/MD/2026/000248 · intended-use annexure · 21 April 2026
Bring guided developmental practice into everyday life. The licensed intended use names parents and caregivers alongside therapists and educators. Families have an explicit role in using the software’s developmental-support functions, with goals and guidance appropriate to their child.
Pinnacle’s Everyday Therapy programme and Fusion Module describe how that participation connects with daily practice, feedback and professional review. The BIS schedule names parent, family and caregiver tracking and correction as part of the connected developmental journey.
Read the MD-5 intended-use annexureRead the BIS connected-module scopeWhat this wording establishes
The intended use identifies whom the software assists and what it supports. It does not confer professional therapist credentials, register a home as a therapy centre or replace appropriate clinical care. A worldwide exclusivity claim is not established by these documents.
WORDS IN THE ORIGINAL BIS SCHEDULE
“for the full developmental lifecycle of children.”
The schedule names AbilityScore, Prognose®, the Everyday Therapy Programme through TherapeuticAI®, the Fusion tracking and correction module, and seven readiness indexes—including Self Sufficiency and Mainstream Inclusion.
This is the named quality-system and software-module scope. The MD-5 records the device’s four intended functions: ability measurement, readiness tracking, progress forecasting and adaptive therapy-plan support. Both documents retain their named software and premises. The MD-5 intended population is ages 0–12; individual outcomes remain subject to the child’s circumstances and support.
Read the full software and developmental-module scope
“Design, development, verification and validation, release, deployment, maintenance, technical support and post-market surveillance of Software as a Medical Device (SaMD), including Pinnacle AI GPT-OS™, and Developmental Support Software (Non-Diagnostic), including developmental ability mapping (Ability Score), prognostic engine Prognose®, Clinical Intervention Every Day Therapy Programme through Therapeutic AI®, Parent, Family, Caregiver, Therapist, Clinical Tracking and Correction Fusion Module, School Readiness, Speech Readiness, Motor Readiness, Study IQ Readiness, Behavior Readiness, Self Sufficiency Index, Mainstream Inclusion Index, 7 readiness indexing and associated digital developmental support modules for the full developmental lifecycle of children.”
BIS MD/L-2026029599 · schedule page 2 · line breaks normalised
Four functions named in the MD-5 intended use
- Developmental ability measurement
- Readiness tracking
- Progress forecasting
- Adaptive therapy-plan support
Parents, therapists, educators and caregivers are the intended users. The licensed software supports developmental work; it does not diagnose, approve every therapy centre or guarantee a child’s outcome.
Class B is a risk classification under India’s rules. US FDA Class II is a different jurisdiction’s classification; neither is a universal ranking of quality or clinical superiority. CDSCO · Medical Devices Rules
INTERNATIONAL LANGUAGE. PERSONAL GOALS.
Structured for understanding.
Designed for connected care.
Section linkFour distinct standards help explain the architecture: health information, functioning and participation, interventions, and clinical terminology. Their value depends on how accurately they are implemented.
World Health Organization
ICD-11 · health information
A common classification and clinical terminology for recording, comparing and aggregating health information. It gives health-related records a consistent reference language.
Pinnacle’s dossier describes ICD-11 reference alignment; this does not make the software diagnostic.
WHO · International Classification of DiseasesPinnacle mapping claims · dossier pages 45–46, 84World Health Organization
ICF · functioning and participation
A framework covering body functions and structures, activities, participation and environmental context. It helps keep daily life and the support needed to participate in view.
Pinnacle’s handout and dossier describe ICF mappings. The dossier’s b-code examples describe body functions; activity, participation and environment need their own relevant codes.
WHO · International Classification of Functioning, Disability and HealthPinnacle mapping claims · dossier pages 45–46, 84World Health Organization
ICHI · health interventions
A classification for recording and analysing health interventions through their target, action and means. It can help describe what intervention is delivered in a consistent way.
Pinnacle’s dossier describes ICHI intervention coding within its architecture.
WHO · International Classification of Health InterventionsPinnacle mapping claims · dossier pages 45–46, 84SNOMED International
SNOMED CT · clinical terminology
A detailed clinical terminology that represents information through concepts, descriptions and relationships. It supports consistent meaning in electronic clinical records.
Pinnacle’s dossier describes SNOMED CT terminology alignment. SNOMED International is the responsible organisation.
SNOMED International · What is SNOMED CT?Pinnacle mapping claims · dossier pages 45–46, 84Pinnacle’s framework, connected to international languages
The Evidence Dossier describes mappings to ICD-11, ICF and ICHI, alongside SNOMED CT and LOINC terminology and HL7 FHIR representations. These are company-described architecture and mapping claims. Correctly implemented mappings can support more consistent records, exchange and analysis across settings.
The reviewed evidence does not include a complete item-by-item mapping audit or implementation-conformance report. Classification alignment does not establish WHO, UN or SNOMED endorsement, validate the developmental score, or expand the MD-5 intended use.
Evidence Dossier, pages 45–46, 84 and 86; September handout, pages 6 and 8WHO classification licence · use and endorsementDESIGNED FOR WIDER REACH
A population-scale ambition. One child’s life at the centre.
Pinnacle describes a connected developmental-support architecture designed for wider deployment: a common framework, a persistent child-specific record, guided daily practice and human review. Its potential value at scale is continuity—helping families and professionals work from the same developmental direction across home, therapy and school.
What makes “sovereign-ready” and “world-ready” meaningful?
For a health system, sovereign readiness means demonstrable control over data and operations under its own governance requirements. International readiness also needs validated mappings, appropriate local language and workflows, applicable regulatory permissions, and evidence of safe, useful performance in that setting.
Local control and accountability
Document hosting location, data-controller responsibilities, lawful use, consent, access controls and audit trails.
Interoperability in practice
Validate the mappings and test information exchange with the systems that will actually use it.
Capacity and real-world value
Test deployment performance, accessibility and child-centred outcomes in the intended population and setting.
The reviewed MD-5 and BIS scope establish specific regulatory and quality-system foundations. Reported network activity and information-security records add context. Together they support examining the deployment proposition; they are not a sovereign-grade certification or authorisation to operate in every country.
How to interpret reported data volume
The reported 2.7 billion+ structured records count database rows and events. They do not establish a nationally representative population, verified AI-training volume or population-level clinical effectiveness.
Dated volume and counting unitsPURPOSE CONNECTED TO GLOBAL PRIORITIES
A wonderful life.
A place to participate.
Section linkPinnacle’s stated mission has practical connections to the UN Sustainable Development Goals: access to support, early learning, inclusion and accountable collaboration.
Health and well-being
A mission to make developmental support clearer and more accessible to families.
Target 3.8 · UN sourceQuality education
Early development, inclusive learning and support that helps children participate in education.
Targets 4.2 and 4.5 · UN sourceReduced inequalities
Participation and inclusion, including for children with disabilities and their families.
Target 10.2 · UN sourcePartnerships for the goals
A direction for accountable collaboration. Specific partnership achievements require named agreements and measured contributions.
Target 17.17 · UN sourceThese are mission connections, not measured SDG achievements, an official UN partnership or UN endorsement. Each child’s right to inclusion remains independent of a readiness score.
GLOBAL PRINCIPLES. PINNACLE’S DOCUMENTED APPROACH.
Why these capabilities
matter to families.
Section linkIndependent guidance explains the importance of monitoring, caregiver participation, coordinated support and inclusion. These organisations do not endorse or evaluate Pinnacle through the references below.
Development happens across a child’s whole day.
The Nurturing Care Framework brings together health, learning, responsive caregiving and supportive environments.
WHO, UNICEF and World Bank · Nurturing CarePinnacle connection
Pinnacle’s seven-stage pathway connects a developmental plan with therapy, home practice and participation goals.
Read Pinnacle’s source recordAsk the care team: How will the plan connect with our child’s day at home and school?
A plan that comes home with you.
“skills that they can use at home to improve their child’s engagement in activities and communication”
WHO describes practical caregiver skills for families of children with developmental delays or disabilities.
WHO · Caregiver skills trainingPinnacle connection
The BIS schedule names Everyday Therapy through TherapeuticAI and parent/family tracking through Fusion.
Read Pinnacle’s source recordAsk the care team: What can we practise between sessions, and who will guide us?
Clarity starts with noticing change.
“Although early intervention is important, intervention at any age can be helpful.”
CDC distinguishes ongoing developmental monitoring from formal screening and professional evaluation.
CDC · Developmental monitoring and screeningPinnacle connection
Pinnacle’s licensed non-diagnostic software includes ability measurement and readiness tracking. This CDC reference does not validate AbilityScore as a screening test.
Read Pinnacle’s source recordAsk the care team: What is our starting point, and when will we review progress?
Shared goals. Clear responsibilities.
NICE recommends coordinated multidisciplinary support and developmentally appropriate parent, carer or teacher involvement for autistic children and young people.
NICE CG170 · Support and managementPinnacle connection
Pinnacle describes integrated therapies and regular plan review. Families can ask how professionals share goals and who coordinates their child’s support.
Read Pinnacle’s source recordAsk the care team: Who brings the team’s observations together into one plan?
More ways to take part.
“UNESCO believes that every learner matters equally.”
Inclusive education addresses barriers in teaching and learning environments.
UNESCO · Inclusion in educationPinnacle connection
Pinnacle’s pathway works toward communication, daily living and participation. Readiness goals do not determine a child’s right to education or inclusion.
Read Pinnacle’s source recordAsk the care team: Which supports will help our child participate with others?
Technology with defined responsibilities.
“Software risk management requires a balanced evaluation of both safety and security.”
IMDRF describes quality management across medical-software development, deployment and maintenance.
IMDRF · SaMD quality managementPinnacle connection
Pinnacle’s MD-5, BIS, quality-system and information-security records document different parts of this accountability picture.
Read Pinnacle’s source recordAsk the care team: What is the software intended for, and how are safety and changes managed?
AUTISM AI & GLOBAL DEVELOPMENTAL CARE
See where Pinnacle fits.
Compare what matters.
Section linkDifferent organisations address diagnosis, assessment, digital treatment, integrated services or provider software. A useful comparison starts with the job each is designed to do.
Pinnacle’s documented combination
Non-diagnostic developmental-support software with an issued MD-5, a BIS schedule naming connected developmental modules, and a company-described seven-stage care pathway. For families, the important connection is between measurement, a plan, everyday practice and review.
MD-5 intended use BIS scope schedule| Organisation / approach | Documented purpose | Source and status | How to read the comparison |
|---|---|---|---|
| Cognoa · Canvas DxAutism diagnostic aid | Prescription machine-learning software that assists clinicians assessing autism in children aged 18–72 months, alongside clinical assessment. | US FDA Class II · De Novo DEN200069 · 2021FDA · Canvas Dx, DEN200069 | Pinnacle’s MD-5 describes non-diagnostic developmental support. These products have different intended uses. |
| EarliTec · EarliPointDiagnostic and developmental assessment | Eye tracking and software to support qualified clinicians’ autism diagnosis and assessment in children aged 16–95 months. | US FDA Class II · K253442 · March 2026FDA · EarliPoint, K253442 | A regulated assessment tool illustrates one part of the journey. Its clearance does not establish a complete care-service network. |
| Akili · EndeavorRxDigital therapeutic | Prescription software for attention function measured by computer testing in children aged 8–17 with specified ADHD presentations, within a therapeutic programme. | US FDA Class II · K231337 · 2023FDA · EndeavorRx, K231337 | A specific therapeutic indication should be compared on its own evidence and population, rather than equated with broad developmental support. |
| CorticaIntegrated care ecosystem | Its published model combines diagnostics, medical care, ABA, developmental therapies and mental-health counselling, involving family, home, school and community. | Provider’s published service modelCortica · Whole-child care model | Integrated child-development care exists internationally. Compare actual coordination, local availability and evidence for the services your child needs. |
| CentralReach · CanaryBIAutism / IDD software and data | Its November 2025 release reports over 5 billion clinical and financial data points in CanaryBI. | Company-reported dataset volume · 2025CentralReach · 2025 autism and IDD care report release | This mixed clinical/financial count and Pinnacle’s structured-record count use different definitions. They do not establish a like-for-like ranking. |
This is a targeted review of five examples, not an exhaustive worldwide census or a head-to-head effectiveness study. It establishes no overall winner, cross-country regulatory equivalence, largest-dataset ranking or global exclusivity.
The better comparison question
“Which combination of measurement, professional support, home practice, progress review and participation goals is actually available for my child—and can I inspect the evidence?”
Read the full context and sourcesSources you can inspect
Section linkRegulator documents establish product indications. Provider pages describe their own services or dataset counts. International guidance supplies context, not a Pinnacle endorsement.
- WHO, UNICEF and World Bank · Nurturing Care
Connected health, learning, responsive caregiving and supportive environments. 29 June 2023
- WHO · Caregiver skills training
Caregiver skills for engagement, communication and daily living; toolkit for ages 2–9. 27 April 2022
- CDC · Developmental monitoring and screening
Monitoring over time, formal screening and appropriate professional evaluation. 16 February 2026
- NICE CG170 · Support and management
Coordinated multidisciplinary support and parent/carer involvement for autistic under-19s; recommendations 1.1.2–1.1.4 and 1.3.1. Updated 14 June 2021
- UNESCO · Inclusion in education
Identifying and removing barriers to participation in education. Checked 18 September 2026
- IMDRF · SaMD quality management
Quality, safety and security across the medical-software lifecycle. 2 October 2015 · N23 FINAL
- CDSCO · Medical Devices Rules
Indian application and licensing framework; MD-3 is an application and MD-5 an issued manufacturing licence. Checked 18 September 2026
- FDA · Canvas Dx, DEN200069
De Novo authorization for an adjunctive autism diagnostic aid, ages 18–72 months. 2 June 2021
- FDA · EarliPoint, K253442
Expanded indication for autism diagnostic and assessment support, ages 16–95 months. 5 March 2026
- FDA · EndeavorRx, K231337
Prescription digital therapy for a defined ADHD attention-function indication, ages 8–17. 13 December 2023
- Cortica · Whole-child care model
Provider-described integration of diagnostic, medical, developmental and behavioural services. Checked 18 September 2026
- CentralReach · 2025 autism and IDD care report release
Company-reported CanaryBI count of over 5 billion clinical and financial data points. 6 November 2025
Pinnacle Blooms Network is a brand of Bharath Healthcare Laboratories Private Limited. View legal identity evidence.