There’s great health diagnostic news for potential AFib patients. Tempus AI, Inc. has received FDA 510(k) clearance for its innovative Tempus ECG-AF device, an AI-based algorithm designed to identify patients at increased risk of atrial fibrillation/flutter (AF). This marks the first FDA clearance for AF indication in the "cardiovascular machine learning-based notification software" category. The device aims to address the challenge of diagnosing AF, a common stroke cause affecting millions.
It's the first in a planned suite of AI-based diagnostics for identifying cardiovascular condition risks. The algorithm analyzes 12-lead ECG recordings to detect signs associated with potential AF occurrence within 12 months. It's intended for use on patients 65 years or older without a known AF history or specific conditions.
Welcome To The Future
AI made its medical debut in the 1970s when the MYCIN AI program was used to help identify treatments for blood infections. In the ‘80s and ‘90s, new AI systems led to advancements in medical data collection and processing, more precise surgeries, in-depth research and mapping, and electronic health records. AI and machine learning are now used in many medical specialties, from radiology and screening to disease diagnosis, primary care, and telemedicine. Most recently, AI has been used to ensure effective medical care.
This FDA clearance represents a significant step forward in the application of AI to cardiovascular diagnostics, potentially improving early detection and treatment of AF. Back in March, the FDA announced its plans to develop a regulatory framework for AI in medical products. Yes, they’re a little behind. As of 2021, the FDA regulated some, but not all, AI-enabled healthcare products. The rapid explosion of AI in all areas of healthcare has pointed out the need for more stringent oversight.
What This Means For Tempus
A public company just recently, the Chicago-based healthcare diagnostics business generated annual revenue of $750 million as of June. Tempus brought in $321 million of revenue in 2022, which grew to $532 million in 2023. However, it has not yet turned a profit, with losses of $290 million and $214 million in 2022 and 2023. More than 7,000 physicians, including at least 65% at academic medical centers, use its platform, as do about 95% of the biggest pharma companies.
This clearance underscores the company’s commitment to providing AI-based clinical solutions for earlier cardiovascular disease identification. Tempus aims to support clinicians in potentially identifying at-risk patients earlier, when treatments may be more effective. The company emphasizes that many AF-related deaths could be prevented through better diagnosis and treatment.
TEM is currently trading around $35.77. Since the company just went public in mid-June, there are no analyst ratings yet.
Neither Julie Stoller nor Stocks.News have positions in this company.
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Contributing Writer
As a professional writer since 2012, Julie Stoller has covered many industries, from healthcare and technology to consumer products and industrials. She has written about IPOs, spinoffs, ETFs, stock splits, commodities, legislative actions impacting investors, and macroeconomic issues. While keeping up with the latest meme stocks and trends, Julie's special interests are discovering ...