Software as A Medical Device (SaMD) Market is projected to grow at an exponential rate during the forecast period

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 software as a medical device (SaMD) market is expected to be driven primarily due to the increased adoption of the Internet of Things (IoT) and connected devices in the healthcare sector.

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

The factors that facilitated the development of the SaMD market and subsequently fueled its momentum.

Healthcare development has benefited from important contributions from the field of IoT, especially when it comes to the transitioning of digital platforms into medical devices that ultimately aid in efficient healthcare service extension. The benefits range from in-patient treatment to population health condition monitoring. Further due to a variety of advantage that arises from the integration of medical software is propelling the healthcare sector to engage in a variety of investments that are inclusive of but not limited to investment in medical software development and IoT. Further the advantages of such integration are also experienced through the benefits of real-time patient health tracking in both residential and hospital settings. This mainly achieved through the aid of wearable devices that comprise data tracking software as well as the ease of use that is availed by monitoring the effect of a particular treatment through software accessed from smartphones or tablets. This also ensures patient adherence. Blood pressure, body temperature, pulse rate, and respiratory rates are a few of the physiological aspects that are can be continuously monitored by SaMD, consequently it constant collection and transmission to health care points. However, the threat of data breach is expected to restrain the growth of the market to a certain extent.

Various developments in the SaMD market brought about by this relatively new cognizance


Grant of License – In April, it was reported that the blood pressure monitoring mobile application by Samsung Electronics Co (KRX: 005930) has been granted Software as a Medical Device (SaMD) license by The Ministry of Food and Drug Safety. It is reported that the software will run on wearable devices and will leverage the blood pressure checking sensors enabling it to function properly.  The plans for the launch of the app is reportedly not later than the 3rd quarter of 2020.

Partnership – In March, global digital health partnership was announced that the between BrightInsight, Inc, the leading provider of regulated Internet of Things (IoT) platform for biopharma and MedTech and AstraZeneca a global biopharmaceutical leader to develop and manage its growing portfolio of digital health products and services within a regulatory-compliant environment. The robust Quality Management System which AstraZeneca intends to capitalize on, enable biopharma and MedTech customers to develop Software as a Medical Device (SaMD), among others while adhering to privacy, security and regulatory compliance.


Receipt of Approval – In October, it was announced that EIRL aneurysm, an image analysis, deep learning-powered software as a medical device (SaMD) that employs deep learning for identifying probable aneurysms from brain MRI, received approval from the Pharmaceuticals and Medical Devices Agency (PMDA), responsible for regulating and approving pharmaceuticals and medical devices in Japan. EIRL is the moniker that the AI medical image diagnostic support technology of LPIXEL is collectively christened. This approval will enable LPIXEL Inc.,which is a leader in image analysis and processing in life science and medical research, to providesolutions that enable a swifter and precise diagnosis by implementing its unique algorithms facilitating the analyses of medical big data, Viz.  brain and breast MRI, chest X-rays, and colonoscopy.

The major players covered as part of the report are among others.

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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