Cardiovascular Disease detection history:
Cardiovascular diseases (CVD) and their health impacts are exponential on a person’s life. While some CVDs are chronic conditions that require extensive care and disciplinary lifestyle changes, many CVDs may lay dormant but can lead to fatal outcomes.
Here are some recent global and US cardiovascular Statistics:
- More than Half a Billion people on the earth were affected by some form of cardiovascular disease (CVD) till 2023!
- Every second adult in the US has some form of CVD in 2024 (Report from AHA)
- CVD was the leading cause of death in the United States in 2020
- Medical costs of CVD in the US are projected to triple from $272.5 billion in 2010 to. $818.1 billion till 2030!
What are the care options?
The traditional care solution for CVDs has been reactive care where on witnessing some symptoms or based on certain incidents, people went for a consultation and then on detection had to rely on medication and lifestyle changes.
For high-risk patients and those dealing with chronic CVDs such as atrial fibrillation (AFib), Blood Pressure, and different types of arrhythmia, there were medical devices available to monitor and manage these conditions.
Medical Devices and Their Role in Cardiovascular Care:
While some medical devices, such as pacemakers, were available for preventing fatal outcomes post-CVD detections, there are many wearable wireless MedTech solutions for accurate Cardiac Monitoring.
These devices were created to manage CVD symptoms and ensure patients get early alerts of rising health parameters that can lead to high-risk medical incidents. While these continuous monitoring cardiac medical devices have been successful in curbing CVD major and fatal incidents to some extent, they have no impact on CVD prevention.
While looking at the above-mentioned statistics, it begs the question ‘Is CVD monitoring enough’?
AI can bring a paradigm shift:
If we look at the larger picture, the need of the hour in Cardiovascular care is the prevention of CVD from happening altogether! To change the CVD narrative from reactive care to preventive care, MedTech innovators are now leveraging AI solutions for the early detection of potential CVDs!
AI-based MedTech start-ups across the world are working in this direction where the use of ECG, Blood Pressure, and Heart Rate datasets are coupled with deep learning ML and AI algorithms to identify dormant heart conditions and provide effective intervention and prevention of CVD.
Rise of new SaMD solutions:
To make this happen, MedTech innovators are running deep-learn ML on the data generated by the continuous monitoring devices along with patient history and observatory data to track trends and patterns in cardiac health data.
These ML models are trained to identify health biomarkers and trends that can point to dormant CVDs and alert the users well in advance to take necessary health measures to avoid a fatal incident. As these ML models are capable of generating new health outcomes independently using device data and patient history, they can be classified as Software as a Medical Device and can function as an independent solution!
Current AI-powered SaMD Use cases and overall progress:
SaMD for early LEF detection:
Currently, AI Algorithms are being developed to Detect Low Left Ventricular Ejection Fraction (LEF) which are positioned as breakthrough Software as a Medical Device (SaMD) to aid clinicians in detecting LEF earlier than ever.
There is also a predictive AI solution that detects the early trend of increased cardiovascular risk, allowing diabetes patients to effectively manage cardiovascular complications leading to Diabetes Cardiovascular Comorbidities Prevention.
Many ongoing AI solution studies are using wearable health data to detect cardiac arrhythmia before onset!
These SaMD solutions hold great promise for Cardiovascular care:
While these AI solutions emerge and become a part of cardiovascular care, AI in MedTech is still in its infancy. Many regulatory, and technical challenges need to be figured out to make these SaMD solutions a part of the care ecosystem.
From regulatory assistance to PCCP-based V&V practices to Lab-as-a-Service for AI-powered SaMD development, we at AIMDek provide the required MedTech expertise to innovators and help them bring their novel breakthrough ideas to life with support from ideation to commercialization.