What's Happening in SaMD Market?

Some consider SaMD a niche. Meanwhile, the SaMD market is one of the fast-developing Medtech subindustries. The global SaMD market accounted for $1.02 billion in 2022 and is anticipated to reach $3.39 billion by 2029. It is expected to register a CAGR of 18.7% over the forecast period from 2023 to 2029. One of SaMD's essential advantages is that building applications for SaMD require fewer resources than hardware development, resulting in rapid growth and maturity. Technology rapidly transforms the healthcare industry by offering innovative, cost-effective, patient-centered tools like SaMD.

The largest medical centers, pharmaceutical, and insurance companies, for example, Mayo Clinic, Aetna, or Cleveland Clinic, are actively using SaMD in their practice and for research purposes. Besides, they develop their own and invest in third-party next-generation medical products.

Let's take a look at 14 SaMD companies that belong to key players in the SaMD market in the US and EU regions, focusing on their impact on the industry.

Top 14 SaMD companies in the US and EU

• Medtronic
• Koninklijke Philips N.V.
• Siemens Healthineers
• MindMaze
• Roche
• Zühlke
• S3 Connected Health

• Pear Therapeutics
• Digital Diagnostics Inc.
• Arterys
• Viz.ai
• Imagen Technologies
• Orthogonal
• BrightInsight

There are, however, many other revolutionary tech companies that have SaMD solutions. And the range of SaMD applications is simply inspiring. From more usual applications like monitoring vitals to rapidly developing ones such as wellness and prevention.?

SaMD for diagnosis and treatment

By analyzing complex medical data and providing insights into a patient's health, SaMD assists healthcare providers in making informed decisions that lead to better treatment planning.

From ECG analysis to breast cancer diagnosis and CBT, SaMD can improve patient outcomes and streamline healthcare delivery.

ECG Analysis Software

SaMD for electrocardiogram (ECG) analysis is used to diagnose heart conditions such as arrhythmia, myocardial infarction, heart failure, etc. The software analyzes the electrical activity of the heart captured in the ECG signal and provides insights into the patient's heart health.

For example: KardiaAI

Computer-aided diagnosis software for breast cancer

SaMD for breast cancer diagnosis uses image analysis techniques to assist radiologists in detecting lesions, masses, and other abnormalities that may indicate the presence of cancer. The software analyzes mammograms or other medical images of breast tissue.

For example: Koios DS

Cognitive behavioral therapy software

SaMD for cognitive behavioral therapy (CBT) helps to treat depression, chronic insomnia, and other mental health conditions. Such software can provide interactive exercises and interventions that help patients learn new coping skills, improve their mood and sleep, etc.

For example: Somryst, Feel Therapeutics

Pulmonary function testing software

This example of SaMD is used to diagnose respiratory conditions like asthma, bronchiolitis obliterans syndrome (BOS), chronic obstructive pulmonary disease (COPD), and combination diseases.

For example: ComPAS2, AI-Rad Companion (Pulmonary)

Sleep diagnostics software

Some SaMD for sleep analysis serves as a diagnostic tool. Physicians can use it to evaluate a patient's sleep quality and improve the efficiency of diagnosing various sleep and respiratory-related sleep disorders.

For example: Sandman Elite

SaMD for monitoring and management

SaMD for monitoring and management offers real-time tracking and sharing of data with a healthcare provider, allowing for more informed decision-making.

Thus, physicians can track and react in time to initial symptoms or any changes in the condition to avoid complications.

Continuous glucose monitoring software for diabetes

This type of software analyzes data from glucose meters and provides real-time information on blood glucose levels, including trends and patterns. It allows individuals with diabetes to make informed decisions about their diet and medication management.

For example: One Drop Blood Glucose Monitoring System, Dario Blood Glucose Monitoring System

Sleep apnea monitoring software

This software analyzes data from a microphone-enabled device to detect breathing patterns and apnea events, and it can rouse the patient in case of interrupted breathing. Using such SaMD, healthcare providers obtain reports regarding the effectiveness of treatment, such as continuous positive airway pressure (CPAP) therapy

For example: EnsoSleep, SleepImage System

Medication management software

This is one of the most common SaMD examples. Such apps are designed to help patients manage their medication schedules. Besides, this software allows healthcare providers to monitor patient medication usage and adjust prescriptions as needed.

For example: Medisafe, AiCure

Remote Patient Monitoring Software

RPM software is designed to help healthcare providers track patients' vital signs, symptoms, and medication usage from a distance. This enables them to intervene quickly if necessary and prevent complications.

For example: Capsule Surveillance, Healthentia

SaMD for prevention and wellness

Examples of software as a medical device for prevention and wellness include various apps that promote healthy behaviors and increase a patient's engagement. They typically monitor health metrics and offer personalized insights and guidance for lifestyle changes.

Fitness and nutrition tracking software

Most consumer apps promoting a healthy lifestyle are not software as medical device examples. Yet, a lot of diseases can be prevented and managed by the means of diet and physical activity. Fitness and nutrition SaMD solutions often target obesity, eating behavior problems, diabetes, migraine, etc.

For example: sinCephalea, Fitterfly

Mobile apps for smoking cessation

Such apps track users' progress, provide personalized guidance, and even measure carbon monoxide levels in their breath. Smoking cessation SaMD can also automatically share the relevant data with a physician, providing them insights into the patient's response to treatment.

For example: CureApp SC

Women's health software

Women's health software can provide personalized insights into fertility, track symptoms, and recommendations for birth control and reproductive health management. Certain SaMD solutions are positioned as a method of digital contraception.

For example: Natural Cycles, Clue Birth Control

Summary

Even though SaMD is a relatively new tool, it has already established itself by improving the lives of millions of patients worldwide. Whether medical device startups, healthcare providers, or pharma companies, healthcare-related businesses are increasingly turning their attention to digital health solutions.

The fact is that the future of healthcare relies on software innovation, and data is the driving force behind this transformation. SaMD solutions and AI/ML are at the forefront of this shift and, according to recent market forecasts, are expected to become even more critical over the next decade.

Contact Binariks if you are also planning your next move in this promising field. We have expertise in creating scalable SaMD solutions and DTx and can provide customized, high-quality services for your project.