Smart MedTech: Unveiling AI-Powered Innovations in Medical Devices

AI is accelerating diagnostics, enhancing treatment precision, and streamlining regulatory approvals in medical devices. Companies that integrate AI are optimizing operations, reducing costs, and expanding into new markets while maintaining compliance and efficiency.

What This Webinar Covers

• AI in Medical Devices: AI adoption in medical devices has surged, with the FDA authorizing nearly 1,000 AI-powered devices between 1995 and August 2024. This rapid growth highlights AI’s role in transforming diagnostics, treatment, and healthcare efficiency.
• Regulatory Pathway: 97% of AI-powered medical devices have secured approval through the FDA’s Substantial Equivalence pathway, demonstrating a clear regulatory route for companies navigating compliance across Class I, II, and III devices.
• Market Entry Strategy: The AI healthcare market was valued at $19.27 billion in 2023 and is projected to grow at a 38.5% CAGR, reaching $187.7 billion by 2030. Companies are positioning AI-powered devices to capitalize on this rapid expansion and enter new markets efficiently.
• Execution at Scale: As AI adoption scales, regulatory approvals have followed. FDA approvals for AI-enabled medical devices increased from six in 2014 to 107 in 2024, reflecting the industry’s rapid shift toward AI-driven solutions. Companies are integrating AI while maintaining workflow stability and compliance.

Who Should Watch?

• Medical device manufacturers implementing AI-driven solutions
• Regulatory and compliance teams managing AI-powered devices
• Business leaders optimizing AI for market growth and expansion