Appinventiv Launches “AI Facts Label” Service to Help MedTech Innovators Meet New FDA Transparency Standards

July 22, 2025 – Appinventiv, a leading provider of healthcare technology solutions, has announced the strategic expansion of its services to include a specialized “AI Facts Label” offering. This innovative service guides MedTech innovators through the FDA’s complex new transparency standards for AI and Machine Learning-enabled medical devices.

For MedTech innovators, the evolving standards represent both a challenge and an opportunity. The complexity of AI models often makes it inherently difficult to convey their intricate workings to non-technical stakeholders, including clinicians and patients. Furthermore, demonstrating the absence of bias, ensuring data diversity, and outlining post-market monitoring strategies require a meticulous approach to documentation and communication.

This is precisely where our “AI Facts Label” service becomes indispensable. Our service is built upon the foundational concept of a “model card” or a “nutrition label” for AI, providing a standardized, patient-centric format for disclosing essential information about AI-enabled medical devices. This approach demystifies AI, making its functionalities, limitations, and underlying data transparent and accessible to all users.

Our Comprehensive “AI Facts Label” Service Encompasses:

1. Expert Regulatory Interpretation and Gap Analysis: 

• • Our team of seasoned regulatory specialists possesses an unparalleled understanding of the FDA’s intricate guidelines concerning AI/ML in medical devices.
  • We work closely with MedTech innovators to conduct thorough audits of their AI development lifecycle, identifying all relevant data points for disclosure and transparency.
  • We pinpoint any gaps in existing documentation or data collection practices, providing actionable strategies to ensure comprehensive compliance with the latest FDA expectations. This proactive approach enables our clients to anticipate regulatory requirements, thereby minimizing costly delays and rework.

1. Development of Standardized, Patient-Centric AI Facts Labels: 

Leveraging our deep expertise, we help craft AI Facts Labels that are not only compliant but also genuinely informative. Key elements meticulously detailed in our AI Facts Labels include:

• Intended use and specific limitations
• Comprehensive training data characteristics
• Transparent performance metrics
• Identified risks and known limitations
• Model architecture and foundation model usage
• Lifecycle management and post-market monitoring
• Accountability and support information

1. Facilitating Rigorous Data Collection and Curation: 
   • We assist innovators in establishing robust data governance frameworks. This includes guiding the collection and curation of high-quality, diverse datasets essential for training unbiased and effective AI models.
   • Our service extends to documenting comprehensive bias mitigation strategies implemented throughout the AI development pipeline, from data acquisition to model validation.
   • We help organize and present the results of clinical validation studies and real-world performance data in a format that seamlessly integrates with the AI Facts Label and other regulatory submissions.

1. Streamlining the Regulatory Submission Pathway: 
   • Our AI Facts Label service streamlines the complex FDA submission process significantly. By providing a standardized, clear, and comprehensive summary of the AI device’s characteristics, we enable MedTech innovators to better prepare for pre-submission meetings with the FDA.
   • This proactive engagement helps clarify expectations, address potential concerns early, and ultimately accelerate the overall review and approval timeline.

1. Building Trust and Promoting Responsible AI Innovation: 

Beyond mere compliance, our “AI Facts Label” service is a testament to our commitment to fostering ethical and responsible AI development in healthcare. By championing transparency, we empower healthcare providers with the necessary information to make truly informed decisions about integrating AI into patient care.

“We are proud to be at the forefront of this critical movement, transforming the regulatory landscape from a hurdle into a pathway for accelerated progress. Our AI Facts Label service is more than just a compliance tool; it’s a strategic enabler for MedTech innovators, enabling them to bring their life-changing technologies to market faster and with greater confidence,” said one of the Directors at Appinventiv.

About Appinventiv:

With a decade of specialized experience in healthcare technology, Appinventiv stands as a globally recognized healthcare software development company. Our expertise is underpinned by a robust team of over 1,600 certified healthcare technology experts, who have successfully delivered more than 3,000 impactful projects. Our unwavering dedication to quality, security, and regulatory compliance positions us as a trusted partner for startups and enterprises worldwide, enabling them to bring visionary ideas to life while adhering to the highest industry standards.

THE AUTHOR

Appinventiv Technologies