AI in Healthcare

Artificial intelligence, Augmented Intelligence, Augmented Reality, and Machine Learning (collectively referred to as AI technologies) are revolutionizing the healthcare industry.

AI technologies, whether in Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD), are rapidly advancing, promising enhanced patient care, improved efficiency, better outcomes, fewer adverse events, and reduced costs. For all of the potential upsides, AI technologies do not necessarily represent a panacea, or do they?

Before incorporating AI technologies into your medical device some key considerations should be explored and assessed.

AI Technologies: Promises and Pitfalls

The rapid acceleration of software and algorithm advancements raises important questions:

• What AI technologies might be appropriate for the intended application?
• What types of sensors and data acquisition elements will be needed to support the technology stacks selected?
• How can we mitigate model bias in data training sets?
• How can we effectively validate models in real-time to ensure their accuracy and efficacy as they adapt to new data and diverse demographics?

Regulatory Benefits

The FDA released an AI/ML-Based Software as a Medical Device (SaMD) Action Plan, outlining a comprehensive approach to enhance oversight of AI-driven medical software. The plan focuses on updating regulatory frameworks, promoting harmonized development of good machine learning practices, ensuring transparency for users, addressing model bias, and advancing real-world performance monitoring to support safe and effective AI products in healthcare. The goal is to allow models to evolve more efficiently without prolonged testing delays.

Transforming Healthcare

AI has great potential to transform healthcare, but careful, ongoing assessment is needed to ensure its effectiveness, safety, and ability to improve care and outcomes. Discover the impact of AI on medtech, clinicians, and patients by reading the full article.

Explore how MedAcuity can help you thrive in a rapidly evolving tech landscape—check out our expertise today.