GE HEALTHCARE DISCUSSION / OCTOBER 2026

01 · INDUSTRY PERSPECTIVE

Regulatory Work Is Slowing Product Launches

AI releases stuck in review: release readiness, lower review cost, control before execution

THE OPPORTUNITY

Releases wait in review. Earlier evidence → fewer repeat reviews → faster, better-informed product-release milestones.

Industry survey—not GE HealthCare results. Preparation time excludes FDA review time.

01Regulatory Work Is Slowing Product Launches

GE HEALTHCARE DISCUSSION / OCTOBER 2026

02 · WHERE GE HEALTHCARE WAITS

Two Places Your Releases Wait

Front-end design at M1, and verification to regulatory submission—the zones your team named

Deciding what to build: applicable regulations, standards and claims identified before technical design decisions—so the PRB process is de-risked early.

Requirements baked in at M1Less wait: verification → submissionFewer PRB surprises

Lifecycle stages as described by GE HealthCare’s quality, regulatory and AI leaders · illustrative, not measured delays.

02Two Places Your Releases Wait

GE HEALTHCARE DISCUSSION / OCTOBER 2026

03 · WHY NOW

Why Buy iGENTIC Now

Launch sooner, keep pace with global change, adopt AI safely—without starting from scratch

Every late evidence gap adds a review loop and pushes the release milestone. Delay compounds across the whole portfolio—earlier gap detection pulls launches forward.

Award-winning · pressure-testedMedTech World NA 2026 Best Use of AI in Healthcare · two years of development reviewed with former FDA experts

Industry membershipAdvaMed member · Mecomed Associate Member

FoundersDr. Zahra Timsah (IQVIA · GSK) · Dr. Ken Washington (former Medtronic CTO)

In marketEnterprise and government clients · RTA Dubai selected after a pilot met agreed KPIs

Membership and awards do not imply regulatory endorsement. Urgency framing is a business argument—actual launch impact to be measured in the evaluation.

03Why Buy iGENTIC Now

GE HEALTHCARE DISCUSSION / OCTOBER 2026

04 · WHAT IS iGENTIC

How iGENTIC Works

Watch evidence move through GENIE—click any step

Proprietary micro-policies: deterministic rules first, semantic analysis for the ambiguous remainder.

04How iGENTIC Works

GE HEALTHCARE DISCUSSION / OCTOBER 2026

05 · WHY DIFFERENT

Built for Regulated Evidence—Not Generic Chat

Compare iGENTIC with the alternatives teams use today

Cites approved sourceChecks evidence completenessConsistent every reviewExpert keeps authorityGoverns connected AI

Proprietary deterministic + semantic micro-policies, source-cited findings and governed AI activity.

Category comparison based on typical capabilities—not an assessment of named vendors. Patent status company-reported.

05Built for Regulated Evidence—Not Generic Chat

GE HEALTHCARE DISCUSSION / OCTOBER 2026

06 · YOUR QUESTIONS, ANSWERED

What GE HealthCare Asked—And Our Answers

Click each question raised by privacy, legal, AI and strategy leaders

PRIVACY & RESPONSIBLE AI ASKED

Under the EU AI Act, what would it have us do for bias mitigation?

Risk tiers are configurable to GE HealthCare’s appetite. For a high-risk system, GENIE flags protected-class or non-de-identified data, cites the requirement and proposes remediation—acting only with your approval.

Flags documentation and data-handling gaps; it is not a model bias assessment.

06What GE HealthCare Asked—And Our Answers

GE HEALTHCARE DISCUSSION / OCTOBER 2026

07 · THE PRODUCT

Faster Reviews. Secure AI. Global Compliance.

Three business outcomes, shown in the actual software

Actual GENIE demo capture: Faster — ACTUAL DEMO CAPTURE · SAMPLE DATA

Quick Check flags evidence gaps before the handoff

Cross-document review: one technical change flags every affected document
Each finding cites passage and requirement, with a suggested fix
Predicate intelligence report from public FDA data
Ask GENIE how to fix it right the first time

Kill switch and monitoring apply only to configured, validated integrations (API/SDK/gateway). Not model validation or bias assessment.

07Faster Reviews. Secure AI. Global Compliance.

GE HEALTHCARE DISCUSSION / OCTOBER 2026

08 · MEDTECH CYBERSECURITY

Cybersecurity Is Now a Release Requirement

Connected devices widen the attack surface—and regulators expect proof before market

THE RISK

Implantables, pumps and imaging systems expand the attack surface via Wi-Fi, Bluetooth, USB and service ports.

HOW iGENTIC TACKLES IT

GENIE checks that threat models and risk controls are documented and traced to ISO 14971 hazards before release.

iGENTIC checks cybersecurity documentation and governs configured AI integrations—it does not replace device security engineering, penetration testing or vulnerability scanning. Incidents per public industry reporting.

08Cybersecurity Is Now a Release Requirement

GE HEALTHCARE DISCUSSION / OCTOBER 2026

09 · ARCHITECTURE & DEPLOYMENT

Fits Your Stack, Your Firewall, Your QMS

Deployment, integration, onboarding and token cost—the CIO’s questions

i-GENTIC architecture: your tech stack connects via API to the i-GENTIC platform (regulatory and policy intelligence, knowledge graph, GENIE micropolicy engine, regulated work, live AI governance, policy-driven response) and on to control and evidence

Kill switch and policy responses apply only to configured, connected integrations. Experts retain approval authority.

09Fits Your Stack, Your Firewall, Your QMS

GE HEALTHCARE DISCUSSION / OCTOBER 2026

10 · THE BUSINESS VALUE

Measure Capacity Released, Not Features Used

Business value—not technology adoption for its own sake

Reviewer capacity

Time screening and resolving findings

Earlier gap detection

Expert-confirmed issues before milestones

Review consistency

Misses and variation across repeated reviews

Traceability

Accurate evidence and requirement references

ILLUSTRATIVE CAPACITY · NOT A FORECAST

ReviewsHours / reviewReduction %

400baseline hours

120reviewer hours released

A measured reduction would release capacity—not automatically cash savings or faster launches. Include findings disposition in total review time.

10Measure Capacity Released, Not Features Used

GE HEALTHCARE DISCUSSION / OCTOBER 2026

11 · NEXT STEP

A Focused POC: One Workflow, Measured

Use case, onboarding, deployment and cost structure—agreed together

Choose one high-wait workflow: verification to regulatory submission, or front-end M1 design-control planning.

One product family, agreed ownersDays-to-weeks onboarding (company estimate)Baseline vs. POC compared

Proposed evaluation · business impact must be measured; expert approval authority stays with GE HealthCare.

11A Focused POC: One Workflow, Measured

GE HEALTHCARE DISCUSSION / OCTOBER 2026

01 · INDUSTRY PERSPECTIVE

Regulatory Work Is Slowing Product Launches

AI releases stuck in review: release readiness, lower review cost, control before execution

THE OPPORTUNITY

Releases wait in review. Earlier evidence → fewer repeat reviews → faster, better-informed product-release milestones.

Industry survey—not GE HealthCare results. Preparation time excludes FDA review time.

01 / 11

Regulatory Work Is Slowing Product Launches

A month or longer

Administrative burden

Incomplete confidence

Two Places Your Releases Wait

Why Buy iGENTIC Now

How iGENTIC Works

Built for Regulated Evidence—Not Generic Chat

What GE HealthCare Asked—And Our Answers

Under the EU AI Act, what would it have us do for bias mitigation?

Faster Reviews. Secure AI. Global Compliance.

Quick Check flags evidence gaps before the handoff

Cybersecurity Is Now a Release Requirement

Fits Your Stack, Your Firewall, Your QMS

Measure Capacity Released, Not Features Used

Reviewer capacity

Earlier gap detection

Review consistency

Traceability

A Focused POC: One Workflow, Measured

Regulatory Work Is Slowing Product Launches

A month or longer

Administrative burden

Incomplete confidence