FDA Issues Warning Letter To iRhythm: An Opportunity For The Cardiac Monitoring Space And One Company In Particular?

The Food and Drug Administration (FDA) has issued a warning to the heart monitoring company iRhythm IRTC, stating that its products include violations of FDA device and labeling standards. This highlights the prevalence of such issues in the sector – and opens up a space and creates opportunities for other companies in the remote monitoring and cardiac device market like Biotricity Inc. BTCY which have maintained a robust, safety-first approach for their products.

Biotricity is a medical technology company that has spent several years building out a complete cardiac product portfolio. Its goal is to provide best-in-class technology, and its innovative products have already helped deliver improvements to patients in the healthcare self-management sector.

The company has consistently maintained an “overbuilding” approach to its products and the data and events they transmit, which ensures that its product limitations far exceed what is required. By positioning itself as a leader with its safety-first approach, Biotricity believes it is able to avoid problems that are affecting companies like iRhythm, an issue the company reports is indicative of problems in the larger healthcare system when it comes to companies that focus on selling drugs or clinical services. 

Some of iRhythm’s key violations as highlighted by the FDA include:

• End users were not told about the limit on the number of events (100 manual and 500 auto). 
• Data including significant arrhythmias requiring physician notification were being held inaccessible since 2017. 
• The FDA was not provided with device updates, including algorithm and hardware changes.
• Labeling and marketing claims stated the device can be used with high-risk patients, which is outside of the device’s use indications. 
• Adverse events were not submitted to the FDA for patient injuries including deaths that may have been related to the other violations by iRhythm.

This news has the potential to shake up the sector and open up a space in the remote monitoring industry. The market was worth $4.4 billion in 2022 and is set to grow at a compound annual growth rate (CAGR) of 18.5% over the next seven years. 

In collaboration with its affiliated cardiologist, Biotricity is focused on providing a premium product within the remote monitoring space. The company seems to be well-positioned to take advantage of the FDA’s announcement and the impact it will have on the remote monitoring sector. 

The company reached a record revenue run rate in April when it passed $13 million in annualized revenue. This extends its growth by more than 8% since March, with the growth being driven by sales of remote monitoring products plus subscription-based recurring revenues. The company anticipates its revenue growth to continue throughout 2023, with the CEO stating that the company was “starting to reach a critical mass with growing device sales.”

Biotricity Brings AI To Cardiac Monitoring

A recent article from the New England Journal of Medicine highlighted the important role of artificial intelligence (AI) in the future of healthcare. According to the article, AI will make it possible to quickly analyze large quantities of data, increasing efficiency and potentially providing new insights.

Biotricity has already been working on AI products for several years, using AI technology to power its medical devices and pull deep data on its patients. Its flagship product, Bioflux®, connects physicians with 24/7 access to real-time data and has already recorded data on over 112 billion heartbeats.

As a result, Bioflux has been able to identify 4,960 cardiac events in its more than 111,000 patients. This saved patients ​​approximately $17,238 each and $85.5 million in total.

There is a significant need for treatments and devices like Biotricity’s that help identify and prevent cardiovascular diseases (CVDs). Costs from treatment and premature death from CVDs are around $219 billion annually. CVDs claimed the lives of close to one million people in 2020, making it the leading cause of death in the United States. 

“Our algorithms for detection of cardiac anomalies are FDA-cleared, and for several years our team of dedicated AI software programmers are continually striving to push that envelope,” said Dr. Waqaas Al-Siddiq, Biotricity Founder and CEO. With a focus on improving patient outcomes through innovative solutions, Biotricity has been working with AI technology and its large datasets over the past few years to develop the next generation of diagnostics. 

As well as iRhythm, companies in the cardiac medical device sector include BioTelemetry Inc., Medtronic MDT and Philips PHG.

Read more about what Biotricity is doing here.

Featured photo by National Cancer Institute on Unsplash.

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