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Tempus Receives U.S. FDA 510(k) Clearance for Tempus ECG-AF, an AI-based Algorithm that Identifies Patients at Increased Risk of AFib

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Tempus AI has received FDA 510(k) clearance for its Tempus ECG-AF, an AI-based algorithm aimed at identifying patients at increased risk of atrial fibrillation/flutter (AF). This clearance is significant as it marks the first FDA approval for cardiovascular machine learning-based notification software targeting AF. The Tempus ECG-AF device analyzes 12-lead ECG recordings to detect AF risk within the next 12 months in patients aged 65 and older without a prior history of AF. The technology aims to aid physicians in early AF detection, potentially improving treatment outcomes.

The clearance bolsters Tempus' position in AI-driven clinical solutions and heralds the launch of a suite of next-generation cardiovascular diagnostics.

Positive
  • Tempus AI received FDA 510(k) clearance for its AI-based Tempus ECG-AF algorithm.
  • First FDA approval in the category of cardiovascular machine learning-based notification software.
  • Helps identify patients at increased risk of atrial fibrillation/flutter (AF), potentially allowing earlier intervention.
Negative
  • The Tempus ECG-AF algorithm is to analyzing patients aged 65 and older without a known history of AF.

The FDA's 510(k) clearance for Tempus ECG-AF is a significant milestone, as it showcases Tempus' innovative approach to leveraging AI for healthcare. This approval enables the company to legally market their AI-driven diagnostic tool, which is poised to help in the early identification of atrial fibrillation (AF), a condition that can lead to severe complications like stroke if left untreated.

Given the prevalence of AF in the aging population, the algorithm's specificity for patients aged 65 and older without a known history of AF or other specified conditions can be particularly impactful. The fact that it analyzes 12-lead ECG recordings—a standard and widely used diagnostic tool in cardiology—means that integration into existing clinical workflows should be relatively seamless. This could potentially lead to widespread adoption in healthcare facilities, improving early detection and treatment outcomes.

However, it is essential to note that the ECG-AF algorithm should not be the sole basis for diagnosis or treatment. Clinicians are advised to use it in conjunction with other diagnostic information. This reduces the risk of misdiagnosis and ensures comprehensive patient care. By aiding in early identification, the tool has the potential to significantly reduce AF-related morbidity and mortality rates.

In summary, this FDA clearance not only validates Tempus' technology but also paves the way for advancements in AI-driven diagnostic tools in cardiology.

Tempus' recent FDA clearance for its ECG-AF device is likely to have positive financial implications for the company. This clearance allows Tempus to enter the lucrative cardiovascular diagnostic market with an FDA-approved AI product. The cardiovascular diagnostic market is expected to grow significantly, driven by an aging global population and increasing prevalence of heart-related conditions.

From a financial perspective, this FDA clearance can be seen as a strong catalyst for Tempus’ stock. It not only enhances the company's product portfolio but also strengthens its competitive position in the healthcare technology sector. This approval could attract new investments and partnerships, boosting the company's revenue streams.

In the short term, the market may react positively to this news, potentially driving up the stock price. In the long term, the successful commercialization of this device could lead to sustainable revenue growth and improved margins, provided the company can scale production and integrate the technology seamlessly into healthcare systems.

Investors should keep an eye on subsequent sales figures, partnership announcements and market adoption rates to gauge the long-term impact on Tempus' financial health.

CHICAGO--(BUSINESS WIRE)-- Tempus AI, Inc. (NASDAQ: TEM), a leader in artificial intelligence and precision medicine, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Tempus ECG-AF device that uses AI to help identify patients who may be at increased risk of atrial fibrillation/flutter (AF). This is the first FDA clearance for an AF indication in the category known as “cardiovascular machine learning-based notification software” and paves the way for physicians to use this innovative algorithm in the care of their patients.

AF, a common cause of stroke, affects millions of people and can be challenging to diagnose. This clearance solidifies Tempus’ innovative approach to offering physicians AI-based clinical solutions that support the potential for earlier identification of cardiovascular disease and conditions. ECG-AF is the first of a suite of next generation diagnostics that Tempus has designed to identify patients at risk for a variety of cardiovascular conditions.

“We believe that there are too many patients who die from AF-related causes unnecessarily due to underdiagnosis or undertreatment,” said Brandon Fornwalt, MD, PhD, Senior Vice President of Cardiology at Tempus. “The clearance of Tempus ECG-AF allows us to better support clinicians in potentially finding patients much earlier, when treatments can be more effective.”

The Tempus ECG-AF algorithm is intended for use to analyze recordings of 12-lead electrocardiogram (ECG) devices and detect signs associated with a patient experiencing AF within the next 12 months. It is for use on resting 12-lead ECG recordings collected at a healthcare facility from patients 65 years of age or older who do not have a known history of AF or other specified conditions. The device provides clinicians with results that should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings and other tests, as well as the patient’s symptoms and clinical history. Tempus ECG-AF does not describe a person’s overall risk of experiencing AF and should not serve as the sole basis for diagnosis of AF. Results should not be used as the basis for treatment of AF and are not intended to rule out AF follow-up.

About Tempus

Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, about Tempus and Tempus’ industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements regarding the potential for Tempus’ ECG-AF device to support physicians and clinicians in finding patients who are at risk for cardiovascular disease and conditions earlier; the expected benefits of such earlier identification of patients; Tempus’ belief that patients at the risk of AF are underdiagnosed and undertreated; and AF-related patient population. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “going to,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release.

You should not rely on forward-looking statements as predictions of future events. Tempus has based the forward-looking statements contained in this press release primarily on its current expectations and projections about future events and trends that it believes may affect Tempus’ business, financial condition, results of operations and prospects. These forward-looking statements are subject to risks and uncertainties related to: the intended use of Tempus’ products and services; Tempus’ financial performance; the ability to attract and retain customers and partners; managing Tempus’ growth and future expenses; competition and new market entrants; compliance with new laws, regulations and executive actions, including any evolving regulations in the artificial intelligence space; the ability to maintain, protect and enhance Tempus’ intellectual property; the ability to attract and retain qualified team members and key personnel; the ability to repay or refinance outstanding debt, or to access additional financing; future acquisitions, divestitures or investments; the potential adverse impact of climate change, natural disasters, health epidemics, macroeconomic conditions, and war or other armed conflict, as well as risks, uncertainties, and other factors described in the section titled “Risk Factors” in Tempus’ Final Prospectus filed with the Securities and Exchange Commission (“SEC”) on June 17, 2024, pursuant to Rule 424(b)(4) under the Securities Act, as well as in other filings Tempus may make with the SEC in the future. In addition, any forward-looking statements contained in this press release are based on assumptions that Tempus believes to be reasonable as of this date. Tempus undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law.

Tempus Communications

Erin Carron

media@tempus.com

Source: Tempus

FAQ

What is Tempus ECG-AF?

Tempus ECG-AF is an AI-based algorithm designed to identify patients at increased risk of atrial fibrillation/flutter (AF) by analyzing 12-lead ECG recordings.

What is the significance of the FDA 510(k) clearance for Tempus ECG-AF?

The FDA 510(k) clearance allows Tempus ECG-AF to be used clinically, marking the first FDA approval for cardiovascular machine learning-based notification software aimed at AF detection.

Who can use the Tempus ECG-AF algorithm?

The Tempus ECG-AF algorithm is intended for use on patients aged 65 and older who do not have a known history of atrial fibrillation or other specified conditions.

How does Tempus ECG-AF improve patient care?

Tempus ECG-AF helps physicians identify patients at risk for AF earlier, potentially enabling more effective treatment and reducing the risk of AF-related complications like stroke.

What does the Tempus ECG-AF algorithm analyze?

The Tempus ECG-AF algorithm analyzes recordings from 12-lead electrocardiogram (ECG) devices to detect signs that a patient may experience atrial fibrillation within the next 12 months.

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