Software as A Medical Device (SaMD) Market is projected to grow at a high CAGR

Knowledge Sourcing Intelligence announces the publication of a new report on “Software as A Medical Device (SaMD) Market – Forecasts from 2020 to 2025” to their offering.

The growing adoption of endorsement the Internet of Things (IoT) as well as the integration of connected devices in the healthcare sector is the major factors that are poised to drive the software as a medical device (SaMD) market.

According to the report, the Software As A Medical Device (SaMD) Market is expected to grow at a very high CAGR.

The growth of SaMD market is dependent on several factors as mentioned below

The use of SaMD is expected to even increase since it can be employed in a broad spectrum of technology platforms that are inclusive of but not limited to commercial platforms that can be purchased over the shelf, medical device platforms and virtual networks, among others. The factors which are poised to drive the growth of this market are not limited to their utilitarian aspects as the increased innovation and adoption of the Internet of Things (IoT) continues to take place across all segments. From the monitoring of population health conditions to the treatment of in-patient, the benefits of the integration of IoT leading to the transitioning of digital platforms into medical devices has been led to an increase in investment by a variety of market players. This integration has led to other benefits for example real-time health tracking of patients in both residential as well hospital settings via data collected from the wearable devices and leading to better patient adherence which is also an added advantage. The opportunities for this market are the regional markets where the connected healthcare is gradually emerging. However, the threat of data breach is going to hinder the growth of the market to a certain extent.

Updates on SaMD Market Developments


Fund Raise– In June,a San Jose, California based startup called Brightinsight Inc. received  US$40 million in series B round of funding enabling it to expand its capabilities to make digital health infrastructure to med-tech and pharma companies globally, through the means of  (a) accelerating time to market and (b)  ensuring compliance to the current regulatory, security and privacy compliance so that these entities can launch products related digital health like SaMD in a relatively swift and hassle-free manner.

License Grant In April, Samsung Electronics Co’s (KRX: 005930) mobile application for blood pressure monitoring was reportedly granted with a Software as a Medical Device (SaMD) license. The authority responsible for this granting of the license is Government of South Korea’s, the Ministry of Food and Drug Safety (MFDS), Concerning the functionalities of the software it was informed that it will operate on wearable devices and will utilize the functionalities of sensors that are intended for checking blood pressure enabling it delivered the results that are being marketed to provide.

Acquisition Again in April it was announced that Novartis AG  (SIX: NOVN); (NYSE: NVS) had completed the acquisition of a US-based software startup called Amblyotech, which has reportedly developed software that employs a unique visual presentation known as the dichoptic display that utilizes a proprietary algorithm and aids in presenting each eye with different images.  This technique developed by the startup has reportedly demonstrated improvements in the vision of individuals suffering from amblyopia (“lazy eye”). This is a potential breakthrough ins remaining medicine through the means of medical technology. With the closure of this transaction the organization plans to develop Amblyotech software as a medical device (SaMD), in partnership with video game developer, Ubisoft.

Partnership– In March, the leading provider of a platform pertaining to regulated Internet of Things (IoT) intended for biopharma and MedTech called BrightInsight, Inc, and the world leader pharma sector called AstraZeneca had announced a global partnership pertaining to foster digital health, wherein the expanding portfolio of digital health products of AstraZeneca will be developed and managed under the purview of an environment that is regulatory compliant


Receipt of Approval In October, it was announced that the independent administrative institution, called Pharmaceuticals and Medical Devices Agency, which is responsible for ensuring the efficacy, quality and safety of medical and pharmaceutical devices in Japan had granted an approval first deep learning-powered SaMD for brain MRI called EIRL aneurysm and its subsequent launch. This announcement came as LPIXEL, which is a leader in processing and image analysis in medical research and life science, had developed its AI medical image diagnostic support technology that reported uses deep learning to identify suspected aneurysms from brain MRI.

As a part of the report the major players operating in the software as a medical device (SaMD) Market, have been covered.

View a sample of the report or purchase the complete study at

This report segmented the Software as A Medical Device (SaMD) on the basis following terms

  • By Device Type

    • PCs/Laptop
    • Smartphone/tablets
    • Wearable Device
  • By Diagnostic

    • Diagnostic
    • Clinical Management
  • By Deployment

    • SmallCloud
    • On-Premise
  • By Geography

    • Americas
    • Europe Middle and Africa
    • Asia Pacific