The Stakes

AI in healthcare is entering a new regulatory era. The FDA is introducing Total Product Lifecycle (TPLC) management and Predetermined Change Control Plans (PCCPs), requiring ongoing validation and monitoring even after market entry. Meanwhile, the EU AI Act, taking effect in August 2026, will impose eight-figure penalties for non-compliance across high-risk AI sectors.

This marks a shift from one-time submissions to continuous assurance — and companies without the right infrastructure will be left behind.

Prenuvo — a global leader in proactive whole-body MRI — faced this reality when seeking FDA clearance for its Body Composition AI. Their reputation, growth, and category leadership depended on proving that their AI could withstand regulatory scrutiny.

They chose Gesund.ai’s GDAP.

Why GDAP Was Mission-Critical

Prenuvo needed more than annotations. They needed a platform built for lifecycle compliance and good machine learning practices:

• End-to-end infrastructure: GDAP integrated data, experts, and validation workflows in a regulatory-grade environment.

• Credible evidence: US board-certified radiologists annotated 40 MRI studies across 16+ anatomical structures, producing inter-reader variability metrics (Dice, ICC, Hausdorff Distance, Bland-Altman) regulators expect.

• Global defensibility: The GDAP evidence package helped to secure Prenuvo’s FDA clearance with a structured framework and supported ISO13485 /MDSAP certification with international notified bodies.

GDAP turned a fragile one-off submission into a repeatable, auditable process — exactly what regulators are mandating.

The Results

✅ First FDA clearance achieved for Prenuvo’s Body Composition AI

✅ ISO13485 /MDSAP certification defended with international Notified Body / Auditing Organization.

✅ Future-proofed for upcoming FDA TPLC obligations and EU AI Act enforcement

Customer Voice

“Gesund’s GDAP platform was the backbone of Prenuvo’s regulatory success. It gave us the infrastructure to generate regulator-ready evidence that withstood the highest scrutiny — from the FDA to International notified bodies; using good machine learning practices to support the development of safe, effective and high-quality artificial intelligence/machine learning technologies that can learn from real-world use. This wasn’t just about one clearance. It was about building an agile, structured framework, using a validated platform; establishing confidence in Prenuvo’s AI pipeline and proving that innovation can scale responsibly when paired with the right assurance partner.”

— Tanima Ghosh, Director of Global Regulatory Affairs & Quality, Prenuvo

Why This Case Matters

Prenuvo’s clearance demonstrates that:

• AI developers need lifecycle-grade infrastructure & GMLP to scale safely and efficiently.

• Regulators can rely on GDAP outputs to assess AI systems with consistency and rigor.

• Healthcare providers and patients benefit from AI systems that are trustworthy, transparent, and defensible.

The Bigger Picture

Prenuvo’s success is proof of a market-wide shift. AI assurance is no longer optional — it is the foundation for regulatory approval, clinical adoption, and public trust.

With GDAP, AI developers accelerate clearance, regulators gain confidence, and patients benefit from safer, more effective AI.