FDA Issues Draft Guidance For AI-Enabled Medical Devices - 1

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FDA Issues Draft Guidance For AI-Enabled Medical Devices

  • Written by Kiara Fabbri Former Tech News Writer
  • Fact-Checked by Justyn Newman Former Lead Cybersecurity Editor

The U.S. Food and Drug Administration (FDA) released draft guidance on January 6, 2025, to support the development and marketing of AI-enabled medical devices throughout their Total Product Life Cycle.

In a Rush? Here are the Quick Facts!

  • Guidance covers product lifecycle: design, development, maintenance, and documentation.
  • Addresses risks like bias and ensures transparency in AI-enabled device design.
  • Public comments open until April 7, 2025; FDA webinar scheduled February 18, 2025.

In their news release , the FDA explains that if finalized, this guidance would be the first to provide comprehensive recommendations covering design, development, maintenance, and documentation, aimed at ensuring the safety and effectiveness of these devices. The guidance is set to be published in the Federal Register on January 7, as reported by Healthcare IT News (HITN).

This draft guidance complements recently issued recommendations on predetermined change control plans for AI-enabled devices, outlining how developers can proactively plan for product updates aftermarket release.

Troy Tazbaz, director of the FDA’s Digital Health Center of Excellence, emphasized the significance of this guidance in addressing the unique considerations of AI-enabled devices.

“The FDA has authorized more than 1,000 AI-enabled devices through established premarket pathways. As we continue to see exciting developments in this field, it’s important to recognize that there are specific considerations unique to AI-enabled devices,” he stated, as reported on the FDA press release.

Key components of the draft guidance include recommendations on how sponsors should describe the postmarket performance and risk management of AI-enabled devices in marketing submissions. It highlights the importance of early and ongoing engagement with the FDA and offers a comprehensive approach to managing risks throughout a device’s lifecycle.

Additionally, the draft addresses strategies to mitigate transparency and bias concerns, providing detailed recommendations to help sponsors identify and manage risks associated with bias during design and evaluation.

The FDA also released draft guidance on using AI in developing drug and biological products, further reflecting the agency’s commitment to fostering innovation while maintaining safety and transparency.

This announcement comes amid the rapid growth of AI, which is transforming healthcare by enhancing diagnostics , predictive analytics , psychological treatment plans , and even medical education .

However, HITN notes in a blog post co-authored by Tazbaz and John Nicol, FDA experts highlighted the significant risks posed by AI’s adaptability in real-world settings, including exacerbating biases in data and algorithms, potentially harming patients and disadvantaging underrepresented populations.

To address these evolving risks, the FDA introduced principles for life cycle management and proposed guidance ensuring performance considerations—such as race, ethnicity, and gender—are prioritized throughout AI/ML device development and monitoring, as reported on HITN.

Finally, the FDA also stated that a webinar is scheduled for February 18, 2025, to discuss these proposals further.

Singapore-Based Digital Edge Raises $1.6 Billion For Data Center Expansion - 2

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Singapore-Based Digital Edge Raises $1.6 Billion For Data Center Expansion

  • Written by Andrea Miliani Former Tech News Expert
  • Fact-Checked by Justyn Newman Former Lead Cybersecurity Editor

The Singapore-based company Digital Edge has raised over $1.6 billion to fund and expand its data centers to meet customers’ cloud and AI demands across Asia.

In a Rush? Here are the Quick Facts!

  • Digital Edge raised $1.6 billion, the new capital combines $640 million of equity and $1 billion in debt.
  • The data center company expects to accelerate expansion in Asia to meet its customers’ cloud and AI demands.
  • The startup expects to expand its presence in Malaysia, India, Indonesia, Japan, South Korea, and the Philippines.

According to the press release , the new capital combines around $640 million of equity investment—including existing and new investors—and $1 billion in debt.

Digital Edge—part of the American investing firm Stonepeak’s portfolio—said the new investments will accelerate its expansion to meet AI and cloud demands from its customers.

“This is a major milestone for Digital Edge and an affirmation of the quality of this platform and our team,” said Samuel Lee, Chief Executive Officer of Digital Edge. “We are very proud of what we have achieved and are excited to deliver on the next phase of AI-ready data center developments.”

The data center company was established in 2020 and operates in multiple countries where it expects to continue its expansion, including Malaysia, India, Indonesia, Japan, South Korea, and the Philippines.

Digital Edge currently has 21 data centers with a power capacity of over more than 500 MW and is developing more with more than 300 MW.

“The level of interest received from existing and new investors is a testament to Digital Edge’s proven track record, expansion capacity, and relentless focus on delivering for our customers across the Asia Pacific region,” said Andrew Thomas, Chairman of Digital Edge and a Senior Managing Director at Stonepeak.