Tempus xR IVD device
Search documents
Tempus AI Enhances AI-Driven Diagnostics With Multiple FDA Approvals
ZACKS· 2025-10-27 14:21
Core Insights - Tempus AI Inc. has achieved significant regulatory milestones in AI-driven diagnostics, including FDA 510(k) clearances for multiple devices in 2025 [1][8] Regulatory Approvals - In September 2025, Tempus received FDA 510(k) clearance for its RNA-based Tempus xR IVD device, which aids drug development through advanced RNA sequencing [1][8] - The Tempus xR IVD assay utilizes next-generation sequencing technology to detect gene rearrangements in RNA from tumor tissue specimens [2] - The updated Tempus Pixel, an AI-powered cardiac imaging platform, also received FDA clearance in September, enhancing its capabilities for cardiac MR image analysis with new T1 and T2 inline maps [3][8] - In July 2025, Tempus obtained FDA 510(k) approval for Tempus ECG-Low EF, an AI software that identifies patients with low left ventricular ejection fraction (LVEF ≤ 40%) [4][8] Competitive Landscape - GE HealthCare received FDA 510(k) clearance for its Revolution Vibe CT system, which improves cardiac diagnoses and reduces exam time [5] - Guardant Health gained FDA approval for its Guardant360 CDx as a companion diagnostic for advanced breast cancer patients [6] Stock Performance - Tempus AI shares have increased by 105.8% over the past year, outperforming the industry growth of 28.4% and the S&P 500's 18.8% [6][8] Valuation Metrics - Tempus AI currently trades at a forward Price-to-Sales (P/S) ratio of 10.26X, significantly higher than the industry average of 5.87X [9] Earnings Estimates - The loss per share estimate for Tempus AI for 2025 has remained unchanged over the past 30 days [10]
Tempus AI Hits $100—Are Shares Due for a Pullback?
MarketBeat· 2025-10-15 17:49
Core Insights - Tempus AI has seen a significant increase in its stock price, rising 155% since its IPO price of $37, with shares reaching a high of $104 on October 9 before closing near $94 on October 13 [1][2] Recent Developments - The company received 510(k) clearance from the FDA for its AI-powered cardiac imaging platform, Tempus Pixel, which provides numerical data about heart tissue health and automates image reporting, leading to a nearly 14% increase in shares [2] - Tempus also gained 510(k) clearance for its Tempus xR IVD device, which analyzes cancerous cells through RNA sequencing, aimed at assisting drug companies in designing better clinical trials [3] - An executive order signed by President Trump on September 30, promoting AI in pediatric cancer research, contributed to a 9% rise in Tempus shares, aligning with the company's mission [4] Market Analysis - The consensus price target for Tempus is just under $72, indicating a potential downside of 24%, although recent targets from analysts like HC Wainwright and Guggenheim suggest modest upside potential of 0% to 4% [5][6] - Tempus trades at a forward enterprise value to sales (EV/S) ratio of around 12x, significantly higher than the average of 6x for U.S. large-cap life sciences tools and services stocks, suggesting the stock may be overvalued [7] - Despite the positive developments, there is uncertainty regarding the market adoption of the newly cleared devices, and the company needs to demonstrate that these products can generate meaningful financial results [8] Analyst Sentiment - Tempus AI currently holds a Hold rating among analysts, with some suggesting that there are better investment opportunities available [10]
Tempus AI's $100 Breakout — Billionaire Cliff Asness Reaps 60% Windfall
Benzinga· 2025-10-09 12:24
Core Insights - Tempus AI Inc has emerged as a significant player in the AI-powered cancer diagnostics sector, with its stock reaching a new 52-week high of over $100, driven by recent FDA clearances and government support for AI in pediatric cancer [1][2][4] Group 1: Company Developments - The FDA granted clearance for Tempus' Tempus xR IVD device, an innovative RNA sequencing tool aimed at personalizing cancer therapies, enhancing the company's position in the healthcare AI market [2] - Billionaire investor Cliff Asness of AQR Capital Management acquired a $54 million stake in Tempus AI, purchasing approximately 850,000 shares at an average price of $55.89, which has since appreciated over 60% as shares now trade near $102 [3] Group 2: Market Trends - The recent executive order from President Donald Trump promoting AI solutions for pediatric cancer has generated optimism within the healthcare AI sector, contributing to the stock's momentum [3] - The combination of FDA approvals, government initiatives, and successful investments in AI-driven companies is creating a favorable environment for growth in the healthcare AI industry, making Tempus AI a stock of interest for investors [4]
Why Tempus AI Stock Is Plunging This Week
Yahoo Finance· 2025-09-25 22:53
Core Insights - Tempus AI stock experienced a significant 161% gain since the beginning of the year, but recently faced a decline following a well-known investor's decision to reduce her position in the stock [1][2] - The stock fell 12.4% from the end of last Friday's trading to the close of Thursday's market session [2] - Ark Invest reduced its position in Tempus AI by 62,352 shares, valued at approximately $5.2 million, impacting its weighting in the ARK Innovation ETF [4] Company Developments - Tempus AI received 510(k) clearance from the U.S. FDA for its RNA-based Tempus xR IVD device, aimed at supporting drug development programs [5] - Despite the reduction in the ARK Innovation ETF, Tempus AI remains the largest position in the ARK Genomic Revolution ETF, with a 10.7% weighting [5][6] Investor Sentiment - The reduction by Ark Invest may cause concern among investors, but the stock's significant position in the ARK Genomic Revolution ETF indicates continued support [6] - Ark Invest's trading strategy often involves buying and selling stocks, suggesting potential future purchases of Tempus AI if the stock price declines further [7]
Cathie Wood Dumps $5.2 Million Worth of This AI Stock, Here's What Ark Bought Instead
Yahoo Finance· 2025-09-24 20:31
Group 1 - Ark Invest sold 62,352 shares of Tempus AI at a closing price of $84.13, totaling approximately $5.2 million [2] - The sale follows Tempus AI's recent FDA 510(k) clearance for its RNA-based Tempus xR IVD device, which had previously boosted the stock price [3] - Ark Invest has been reducing its position in Tempus AI, having sold 43,157 shares worth $3.76 million on September 18 and $2.1 million worth of stock on September 9 [4] Group 2 - Other notable trades by Ark Invest include purchasing 28,272 shares of Arcturus Therapeutics Holdings Inc. and selling 46,876 shares of Roku Inc. [7]
Cathie Wood Dumps $5.2 Million Worth of This AI Stock, Here's What Ark Bought Instead - Tempus AI (NASDAQ:TEM)
Benzinga· 2025-09-24 01:17
Group 1 - Ark Invest sold 62,352 shares of Tempus AI at a closing price of $84.13, totaling approximately $5.2 million [2] - The sale follows Tempus AI's recent FDA 510(k) clearance for its RNA-based Tempus xR IVD device, which had previously boosted the stock price [2][3] - Ark Invest has been reducing its position in Tempus AI over the past few weeks, having sold 43,157 shares for $3.76 million on September 18 and $2.1 million worth of stock on September 9 [3] Group 2 - Benzinga's Edge Stock Rankings indicate that Tempus AI stock performs well across Short, Medium, and Long Price trends [5]