AI/ML-Enabled Medical Devices Market: Current Analysis and Forecast (2024-2032)

Artificial intelligence and machine learning are two powerful technologies that are disrupting a vast number of industries, including medical devices. These technologies allow different devices to take large amounts of information, then distinguish patterns and make a prognosis. The final effect is more precise diagnostics, an individualized approach, and better conditions for the patient. Examples of intelligent medical devices include imaging systems and pathology scanners, wearable devices that constantly check the health status of patients, and those that allow doctors to diagnose diseases. It is important because they have a significant capability to increase the effectiveness of healthcare delivery while decreasing the stock of mistakes and enhancing the specificity of inpatient treatment plans. The necessity of smart medical devices to support the development of smart technologies is the major reason for the growth of the market. The global market for AI/ML-enabled medical devices is fueled by several other requirements, including an increase in technological enhancements and a rise in the number of corporate partnerships and acquisitions.

The AI/ML-Enabled Medical Devices Market is expected to grow at a steady rate of around 26% owing to the rising development of new innovative products. For instance, in November 2023, Philips accelerated the growth of AI-enabled healthcare solutions with an MLOps platform built on Amazon SageMaker. SageMaker provides purpose-built tools for machine learning operations (MLOps) to help automate and standardize processes across the ML lifecycle, helps teams easily train, test, troubleshoot, deploy, and govern machine learning models at a scale, boosting the productivity of data scientists and machine learning engineers while maintaining model performance in production. Several other factors, including increasing demand for personalized medicine, the explosion of healthcare data, the expanding distribution channels, and strategic partnerships between medical device companies, drive the market's growth during the forecast period. Apart from this, improving the affordability and accessibility of AI/ML-enabled medical devices are also driving this market steadily.

Based on product type, the market is bifurcated as hardware and software. For this segment, in 2023, the software segment dominated the market. The software segment comprises algorithms, applications, and platforms that deploy AI and ML capabilities to analyze certain medical data and create prediction models for clinical utilization by healthcare practitioners. By using this software, healthcare providers may examine and analyze medical information such as images, signals, and records of patients, efficiently diagnose their conditions, and effectively manage treatment for improved patients' wellness. The software segment, therefore, enjoyed a relatively high market share in 2023 of the product types.

Based on the clinical area, the market is segmented into radiology, cardiology, hematology, and others. The radiology segment dominated the segment in the year 2023. The radiology segment focuses on applying AI and ML technologies to radiological imaging modalities such as X-rays, CT scans, MRI, and ultrasound. AI and ML are applied in image interpretation, especially in radiology, where algorithms help radiologists identify diseases, make diagnoses, and even provide recommendations on the kind of treatment that the patient requires. The above technologies should be used to enhance the efficacy of the interpreting of radiology images to enable quick diagnosis, reduction of mistakes, and personalized care for the patients. Further, these devices work synergistically with picture archiving and communication systems, PACS, electronic health information and record systems, and EHR to enhance the overall workflow and interaction among caregivers. Thus, the radiology segment held a significant market share in 2023 among the clinical areas.

Based on the end-user, the market is segmented into hospitals, pharmaceutical companies, and others. Hospitals are expected to grow significantly in the forecast period. These devices employ intelligent solutions to support healthcare workers in the understanding and analysis of images, identification of diseases, the definition of an appropriate treatment process, and monitoring of patient's health. In general, successful ML algorithms can be applied to devise individualized therapies grounded on characteristics peculiarities and prediction models. Some of the routine processes like documentation, scheduling appointments, and billing can also be conducted by AI-based software, hence minimizing the work of health personnel in those areas. Most of their time can be spent attending to patients. Consequently, hospital-segment medical devices with AI and ML technology are vital to enhancing the ambiance of delivering care, augmenting patient experience, and operationalizing healthcare organizations. Thus, the hospitals are expected to grow with a significant CAGR in the forecast period.

For a better understanding of the market adoption of AI/ML-enabled medical devices, the market is analyzed based on its worldwide presence in countries such as North America (U.S., Canada, and the Rest of North America), Europe (Germany, U.K., France, Spain, Italy, Rest of Europe), Asia-Pacific (China, Japan, India, Rest of Asia-Pacific), Rest of World. The AI/ML-enabled medical device market experienced a sharp rise in North America, leading to the region's dominance in the market in 2023. This growth can be attributed to the rising product launches of AI/ML-enabled medical devices, medical device company expansions, and rising company collaborations & acquisitions. For instance, in November 2023, U.S.-based MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm, launched its AI & Imaging Center, the first and only integrated solution, led by former FDA imaging experts covering the entire Medical Device product lifecycle. Apart from the mentioned factors, other factors, such as the improving affordability and accessibility of medical devices, are propelling the region's market growth. Thus, amongst areas, North America held a significant share of the market in 2023.

Some of the major players operating in the market include Aidoc, CANON MEDICAL SYSTEMS CORPORATION, CellaVision, Clarius, GE HealthCare, HYPERFINE, INC., Koninklijke Philips N.V., Medtronic, Nano-X Imaging LTD., Siemens Healthcare Private Limited.