A practical introduction to the Shen AI Medical SDK

The Shen AI Medical SDK is a CE-marked Class IIa software as a medical device (SaMD) under the European Medical Device Regulation (MDR). It enables certified estimation of blood pressure, heart rate, heart rate variability, and breathing rate through a one-minute face scan using a standard camera. No wearable or additional hardware is required.

This guide is a starting point for teams evaluating or preparing to build with the Medical SDK. For the full technical and regulatory details - including the approved Intended Purpose, measurement conditions, limitations, and integration requirements - refer to the Instructions for Use (IFU) and medical device documentation provided during onboarding.

What the certification covers

The Medical SDK received its CE certification from TÜV Rheinland in July 2026. The certified scope covers four physiological parameters:

• Heart rate
• Heart rate variability (SDNN)
• Breathing rate
• Blood pressure, including systolic and diastolic pressure

The certification process went beyond measurement performance; it covered the applicable MDR safety and performance requirements, clinical validation against reference methods, software and algorithm performance, cybersecurity, usability, risk management, and the quality management system behind the product.

“This is an important point, because medical certification is much broader than testing whether the algorithm works. The assessment looked at the whole product and the whole quality management system behind it - intended purpose, risk management, software development process, cybersecurity, usability, clinical evidence, and of course the performance of the measurement functions.”
Anna Szopa, Chief Quality and Regulatory Officer, Shen AI 

Shen AI's quality management system is certified to ISO 13485, and its information security management system is certified to ISO/IEC 27001.

The result is a medical device with a defined Intended Purpose, defined indications and limitations, and a controlled medical configuration. The Medical SDK is a separate product from Shen AI's Wellness SDKs and is designed specifically for organizations building regulated medical applications.

How the technology works

The Medical SDK uses two complementary signals captured by a standard RGB camera.

The first is based on remote photoplethysmography (rPPG). Skin is translucent, and the blood vessels beneath it change in volume with each heartbeat. This creates subtle, repeating changes in skin color that a camera can capture and process.

The second is remote ballistocardiography (rBCG). Each heartbeat causes tiny mechanical movements as blood is ejected from the heart. These movements are too small to see with the naked eye, but can be detected through computer vision.

The SDK combines these two signals to extract information from both color changes and movement. Together, they provide the basis for the certified physiological measurements.

All physiological processing and inference happen on the user's device, in real time. Biosignals are not sent to the cloud. The SDK does require periodic communication with the licensing server, which handles technical license validation; this is separate from the physiological measurement process.

Medical SDK or Wellness SDK?

Shen AI offers different SDK options for different product goals and regulatory pathways. The key decision is not which SDK is technically "better," but what your product is intended to do and what you need to claim about it.

The Wellness SDK is designed for products focused on health awareness, prevention, lifestyle, employee wellbeing, insurance wellness, and other wellness-oriented use cases.

The Medical SDK is designed for organizations building regulated medical applications that require certified Software as a Medical Device.

The distinction matters because the regulatory pathway follows the product's intended use and claims. With the Medical SDK, user-facing claims, instructions, and the measurement workflow must remain within the approved Intended Purpose and IFU.

Making this decision early—before the choice is built into your product's UX, messaging, and claims—helps keep your regulatory strategy and development process aligned.

What building with the Medical SDK looks like

The Medical SDK is provided through a guided onboarding process. After signing the license agreement, partners receive access to the SDK and the relevant medical device documentation, including the CE certificate, Declaration of Conformity, Instructions for Use, and product documentation.

The Medical SDK has a fixed, documented scope. Compared with the Wellness SDK, there are several differences teams should plan for:

• Metrics: heart rate, HRV, breathing rate, and blood pressure only. Additional wellness metrics and health risk indicators are not currently part of the Medical SDK.
• Measurement duration: the certified measurement takes 60 seconds.
• UI and workflow: the medical device experience is controlled and cannot be freely customized. Changes affecting the user interface, measurement workflow, results presentation, or regulated functionality require appropriate review.
• Branding: the Medical SDK cannot currently be fully white-labeled and must remain within its approved medical device branding requirements.
• Updates: changes to the Medical SDK are controlled and documented, so its update cadence is different from the Wellness SDK.

The Medical SDK is not simply a version of the Wellness SDK with a CE mark added. It is a separate product with its own integration, documentation, intended purpose, and regulatory requirements.

Designing for remote patient monitoring

For teams building remote patient monitoring or other longitudinal use cases, some product decisions are worth considering early.

Patient identity: Measurements need to be correctly associated with the person using the application.

Data handling: Decide where measurement results should be handled and displayed—whether in the application, a dashboard, on-device, or through an integration with an existing healthcare system.

Adherence: A single measurement provides a snapshot. Repeated measurements can provide a more useful view of changes over time, so reminder flows and other adherence mechanisms may be important parts of the product experience.

These decisions sit outside the measurement SDK itself, but they can have a significant impact on how useful the technology becomes within a real care workflow.

Market availability

The Medical SDK currently has medical device registrations in the European Union and Brazil:

• EU: CE-marked Class IIa under the EU MDR
• Brazil: Registered with ANVISA as a Class II medical device

The CE certification does not automatically authorize the Medical SDK in other markets.

For the United States, Shen AI is planning an FDA pre-submission followed by a 510(k) submission. The Medical SDK is not currently FDA-cleared; the General Wellness SDK is the Shen AI product available for the US market under the applicable FDA General Wellness framework.

Regulatory requirements vary by market, so organizations planning deployment outside the currently certified markets should assess the applicable local requirements.

To learn more about the Medical SDK or discuss whether it fits your product, contact the Shen AI team.

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