A New Signal from FDA: What the Inclusion of sDHTs Means for Life Sciences

Jennifer Goldsack & Sarah A.

Last week, the FDA added a new category to its lists of medical devices that incorporate digital health technologies: sensor-based digital health technologies (sDHTs). These are the tools that capture real-world, high-resolution data like movement, glucose levels, heart rate, voice, and sleep patterns using sensors embedded in technologies you wear, keep in your pocket, and have in your home and translate them into meaningful insights for care and research.

This is a catalytic moment for the life sciences industry. For the first time, sensor-based technologies are now included alongside AI/ML-enabled and AR/VR tools in a publicly available FDA dataset, with therapeutic area, clearance date, and review panel all listed. That simple act carries weight. It reflects the FDA’s growing recognition that sDHTs are part of mainstream healthcare and drug development. It also brings increased visibility to the growing number of devices authorized for market access that generate data already being used in trials as digital endpoints.

At DiMe, we immediately compared the newly published list to our Library of Digital Endpoints and findings from our recent work on the ROI of digital endpoints in drug development.

Here’s what the data tell us… and why this matters.

📊 The evidence: The opportunities are real and actionable

We analyzed 505 digital endpoints from DiMe’s Library of Digital Endpoints (2005–2024) and 215 FDA-authorized sDHTs (2015–2025). What we found is pretty fascinating…

📌 1. Glucose leads the way.

• 23% of endpoints reference glucose.
• 17% of FDA-authorized sDHTs fall under “clinical chemistry”. All continuous glucose monitors.
• Dexcom alone accounts for 44% of the sDHT authorizations related to CGMs.

💡 Implication: The path from device clearance to trial integration is well-trodden in endocrinology. The CGM model shows what’s possible when technology, evidence, and regulation align.

📌 2. Cardiovascular devices dominate regulatory authorizations for market access, but not endpoints.

• 52% of sDHTs were authorized under FDA’s cardiovascular panel.
• Yet only 9% of digital endpoints in LODE are cardiac-related.

💡Implication: Cardiac wearables are widely trusted for safety monitoring, but they remain underleveraged as efficacy endpoints. This is low-hanging fruit for sponsors.

📌 3. Sleep is scientifically active but under-represented in sDHT clearances.

• Sleep/wake accounts for 18% of digital endpoints (85 of 505) used by industry, second only to glucose.
• But sleep-focused sDHTs are nearly absent from FDA market authorizations, representing only only 10 cleared sleep‑specific devices (~5 % of 215)—most are home sleep–apnea tests or respiratory wearables filed under Respiratory, with a few EEG‑based systems in Neurology.

💡 Implication: Likely both (a) consumer-grade devices are being used to capture data to inform digital endpoints, as has been clearly stated as acceptable by the Agency in final guidance, and (b) the pathway to clearance is too ambiguous and/or the commercial value for sDHTs measuring sleep as part of routine care has yet to be made. Given the known impact of sleep on almost every major disease and our mental health, there’s work to do here.

📌 4. Neurology is growing in lockstep across both datasets.

• Roughly 16–18% in both DiMe’s endpoints library and the FDA sDHT list.
• Moderate but steady year-on-year growth.

💡 Implication: Steady progress. But we’re waiting for a breakout moment, possibly around seizure detection or digital tools for use in Parkinson’s Disease, which is a particular focus for industry right now.

🔍 Regulatory signal, strategic opportunity

At DiMe, we see the inclusion of sDHTs in FDA’s public device lists as an invitation to act. For life sciences, it signals that these technologies have moved far beyond experimental and exploratory to become viable tools ready to be integrated into development programs.

We also recognize that in today’s market, reduced regulatory uncertainty will not drive investment and adoption. We need to also provide sponsors with a clear business case. That’s why we’ve dedicated enormous efforts here at DiMe in the last few years to quantify the financial, operational, and patient benefits of using sDHTs in clinical research.

When the science, the policy, and the economics align, momentum follows. This update from FDA creates the regulatory foundation for rapid adoption of digital endpoints to modernize trial design, and to build smarter, more efficient development strategies that deliver a double bottom line to both their own P&L and the patients our industry exists to serve.

📈 The business case is clear

The regulatory clarity reflected in FDA’s new list of sDHTs removes a long-standing perceived barrier to digital endpoint adoption. But in today’s environment, regulatory alignment is only one part of the equation. Adoption at scale requires financial justification.

DiMe’s Digital Health Measurement Collaborative Community (DATAcc) took all of the CNS, diabetes, and cardiovascular trials in our digital endpoints library and compared them with 11,466 matched studies that did not leverage digital endpoints. When digital endpoints were used, we found that:

• Trial sizes were reduced by 14% in Phase 2 and 12% in Phase 3
• Trial durations were reduced by 24% in Phase 2 and 22% in Phase 3
• ROI was over 3x in Phase 2 and up to 22x in Phase 3 diabetes trials, with estimated net present value coming in at a whopping $44M

📚 Explore the full suite of resources supporting the business case for digital endpoints

Our data show that using sDHTs delivers outsized strategic, operational, and financial benefits to clinical trials, whether for drugs, devices, biologics, or gene therapies. These advantages are already being realized by forward-looking sponsors, and as they build operational experience and generate valuable data assets, they are positioning themselves for disproportionate gains in the market. Now, with clearer regulatory signals, more companies have the certainty they need to follow suit and avoid falling behind.

🔜 What comes next

To build on this momentum, our DiMe team is leveraging our DATAcc initiative to develop a practical, comprehensive online resource for sponsors and sDHT developers. This interactive hub will be the one stop shop for any life sciences company seeking to deploy digital endpoints, as well as the developers building the sDHTs to capture the necessary data:

• Clear guidance on regulatory strategy
• ROI modeling tools
• Case studies and implementation support

For life sciences teams

If you're working to modernize your trial design, reduce costs, or increase patient relevance, the tools already exist and the regulatory signal is increasingly clear. DiMe is here to help you apply them effectively.

The inclusion of sDHTs in the FDA’s public-facing lists gives us one more point of alignment between evidence generation, regulatory expectations, and digital innovation. Now is the time to act on it.

📩 Reach out to explore how we can support you: partnerships@dimesociety.org

#DigitalHealth #FDA #sDHT #DigitalEndpoints #HealthTech #ClinicalTrials #RegulatoryScience