North America Software as a Medical Device Market Growth and Recent Trends by 2027

Historic Data: 2017-2018 | Base Year: 2019 | Forecast Period: 2020-2027

North America Software as a Medical Device Market Forecast to 2027 - COVID-19 Impact and Regional Analysis By Device Type (PCs/Laptops, Smartphones/Tablets, Wearable Devices), Application (Screening and Diagnostics, Monitoring and Alerting, Disease Management), Deployment Type (Cloud, On-Premises), and Country

Report Date : Apr 2020
Report Code : TIPRE00010412

Category : Technology, Media and Telecommunications
Status : Published

Available Report Formats :
No. of Pages : 110

Analysis Strategic Insights Market Drivers Regional Insights Report Scope Recent Developments FAQs

The North America Software as Medical Device market is expected to reach US$ 39,854.20 Mn in 2027 from US$ 8,353.94 Mn in 2019. The market is estimated to grow with a CAGR of 22.2% from 2020-2027.

The growth of the market is driven by the factors such as, increasing adoption of IoT in healthcare and advantages of software as medical device (SaMD) .On the other hand, threat of data breach is likely to restraint the growth of market during the forecast years.

The North American Software as Medical Device market is expected to witness significant growth during the forecast period, due to factors such as the rising adoption of Internet of Things (IoT) in healthcare services for screening and monitoring of patient may offer vital growth opportunities for market growth. The US is among the top countries in the field of software as medical device. The presence of key players in the country and guidelines proposed by the US FDA for software as medical device are driving the growth of software as medical device in country.

The growth of the North American software as a medical device market is primarily driven by increasing adoption of smart health monitoring devices, transformation of digital healthcare, increasing number of chronic diseases, and support from the federal governments to implement digital tools in healthcare to cut down the costs and improve the quality of care. According to the US FDA, software has become an important part of all the products that are widely integrated into the digital healthcare platforms. The FDA also states that the use of software as medical device is continuously increasing in the US. The implementation of these devices is broadly seen across a range of digital platforms, including commercial off-shelf platforms, virtual networks, and medical device platforms. The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators that have come together to develop a harmonized regulation on medical devices. The US FDA specifies certain criteria to qualify software as medical devices.

North America Software as Medical Device Market Revenue and Forecast to 2027 (US$ Mn)

This FREE sample will include data analysis, ranging from market trends to estimates and forecasts.

North America Software as Medical Device – Market Segmentation

By Device Type

PCs/Laptops
Smartphones/Tablets
Wearable Devices

By Application

Screening and Diagnosis
Monitoring and Alerting
Disease Management

By Deployment Type

Cloud
On-Premises

By Country

US
Canada
Mexico

Company Profiles

Velentium LLC
Tietronix Software, Inc.
S3 Connected Health
Zühlke Group
Science Group
Inzentiz
Cambridge Consultants Inc
BrightInsight, Inc.
CompliancePath
Jabil Inc.
Phillips-Medisize
Pro4People Sp. Z.o.o

North America Software as a Medical Device Report Scope

Report Attribute	Details
Market size in 2019	US$ 8,353.94 Million
Market Size by 2027	US$ 39,854.20 Million
Global CAGR (2020 - 2027)	22.2%
Historical Data	2017-2018
Forecast period	2020-2027
Segments Covered	By Device Type PCs/Laptops Smartphones/Tablets Wearable Devices By Application Screening and Diagnostics Monitoring and Alerting Disease Management By Deployment Type Cloud On-Premises
Regions and Countries Covered	North America US Canada Mexico
Market leaders and key company profiles	Velentium LLC Tietronix Software, Inc. S3 Connected Health Z

Research Manager

Ankita Mittal

Manager,
Market Research & Consulting

Ankita is a dynamic market research and consulting professional with over 8 years of experience across the technology, media, ICT, and electronics & semiconductor sectors. She has successfully led and delivered 100+ consulting and research assignments for global clients such as Microsoft, Oracle, NEC Corporation, SAP, KPMG, and Expeditors International. Her core competencies include market assessment, data analysis, forecasting, strategy formulation, competitive intelligence, and report writing.

Ankita is adept at handling complete project cycles—from pre-sales proposal design and client discussions to post-sales delivery of actionable insights. She is skilled in managing cross-functional teams, structuring complex research modules, and aligning solutions with client-specific business goals. Her excellent communication, leadership, and presentation abilities have enabled her to consistently deliver value-driven outcomes in fast-paced and evolving market environments.

What are the North America Software as a Medical Device Market report deliverables?

Historical Analysis (2 Years), Base Year, Forecast (7 Years) with CAGR
PEST and SWOT Analysis
Market Size Value / Volume - Global, Regional, Country
Industry and Competitive Landscape
Excel Dataset

North America Software as a Medical Device Market Report Snapshots

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