Over 1500 New and Updated Digital Health Technologies in sDHT, AI SaMD, and AR/VR
In a recently published update of digital health technologies listings, the FDA has consolidated their approved devices and SaMD listings for sensors (sDHT), AI medical devices and AR/VR. The FDA enables the development of innovative, safe, and effective medical devices that incorporate digital health technologies. In the context of medical IoT devices and systems the FDA published excel sheets and lists of medical devices that received clearance for patient use:
Out of 215 sensors listed, well known use-cases of blood glucose measurement (e.g. Dexcom G7 variants) or Apple’s Airpod Hearing Aid feature are included. But also applications for Parkinson’s Disease treatment like Neuhealth Digital’s sensor or the Parky App are present.
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In general, Class II devices in a field, e.g. anesthesiology and respiratory, are listed alongside for both clinical and at-home use.
Leaders in terms of numbers of listings are Dexcom, iRythm and Abbott Diabetes Care.
Top primary product codes are:
- MNR: Ventilatory Effort Recorder
- DQA: Oximeter (non-ear)
- DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency
- QBJ: Factory Calibrated Continuous Glucose Monitoring System, Factory Calibrated
- DXN: Non-Invasive Blood-Pressure Measurement
accounting for 40% of these digital sensor solutions for medical applications.
Related to intelligent devices, backend systems and web-services lists regarding
- artificial intelligence-enabled medical devices, and
- medical devices that incorporate augmented reality and virtual reality have been updated.
Not so surprisingly, these two lists comprise over 1300 digital health applications. Many of them are long-term evolutions of intelligent image processing and detection systems for radiology, but AR/VR make their headway into the therapy field as well.
If you’re working with intelligent digital health systems, understanding how to develop secure medical device software with design controls can significantly accelerate compliance and market-readiness.
Leaders in terms of numbers of listings are Siemens, Canon, Aidoc Medical, and many more. Big names in consumer devices making it on the FDA listings include Apple and Samsung.
Out of the 1300 entries almost 500 make up the top 3 primary product codes, dominated by pure software, followed by x-ray and ultrasound imaging:
- QIH: Automated Radiological Image Processing Software (automated radiological image processing and analysis tools; software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data; adaptive AI algorithms are not within scope of this product code, in these devices, the algorithm training data typically impacts device performance.)
- LLZ: System, Image Processing, Radiological
- IYN: System, Imaging, Pulsed Doppler, Ultrasonic.
These trends reflect the impact of digital innovation management and data-driven business models that are transforming medical device software pipelines.
Digital health innovators can use such devices as predicate devices to describe substantial equivalence in new FDA submissions, screen the medical device lists to gain insights into the current device landscape and regulatory expectations, or even incorporate sensors in their own solutions and health software. If you’re aiming to build compliant software, make sure you’re aware of IEC 81001-5-1 cybersecurity controls that guide secure development of connected health systems.
The innovation trend in medical device software approval with predicted values for 2025 can be clearly seen below:
![Sensaco GmbH and raw data from FDA 1]
Source: Sensaco GmbH and raw data from FDA digital health blog posts and newsletters.
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Also, take a closer look at our efforts in ensuring medical software cybersecurity in modern health systems — a crucial aspect for any digital health product seeking FDA clearance.
