Latest news with #ZioAT
Yahoo
31-07-2025
- Business
- Yahoo
FDA Clearance Boosts iRhythm Zio Device Innovation and Fuels Growth Potential
iRhythm Technologies, Inc. (NASDAQ:IRTC) is one of the . The FDA clearance for the Zio AT device upgrades signals the potential for further innovation and stock growth. A patient being monitored with a portable ECG device, showing the effectiveness of the company's products. Based in California, iRhythm Technologies, Inc. (NASDAQ:IRTC) is a digital healthcare company focused on transforming cardiac arrhythmia detection through wearable biosensors and cloud-based data analytics. Zio by iRhythm platform, the company's flagship product, makes use of a wearable biosensor patch and cloud-based analytics for monitoring heart rhythms for extended periods, aiding in the diagnosis of cardiac arrhythmias. iRhythm Technologies, Inc. (NASDAQ:IRTC) recently got the FDA 510(k) clearance for design modifications and labeling updates to its Zio AT device – a prescription-only mobile cardiac telemetry (MCT) system used for long-term ECG monitoring of both symptomatic and asymptomatic heart events. The clearance, effective from 2025, allows the device to remain commercially available in the U.S. Following the clearance, the company also launched Zio ECG Recording and Analysis System in Japan in May 2025, with nationwide availability anticipated by July 2025. Following these developments, Robert W. Baird maintained a Buy rating on the stock with a price target of $160. With a 1.17% uptick in its weekly performance, the stock had a closing price of $137.11 as of July 28, 2025. Insider Monkey database reported 31 hedge funds holding stakes in iRhythm Technologies, Inc. (NASDAQ:IRTC), reflecting a modest level of institutional confidence. While we acknowledge the potential of IRTC as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 11 Best Long Term Low Risk Stocks to Invest in and 13 Best Low Risk High Growth Stocks to Buy Disclosure. None.
Business Wire
27-06-2025
- Business
- Business Wire
IRHYTHM INVESTIGATION CONTINUED by Former Louisiana Attorney General: Kahn Swick & Foti, LLC Continues to Investigate the Officers and Directors of iRhythm Technologies, Inc.
NEW YORK & NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC ('KSF'), announces that KSF continues its investigation into iRhythm Technologies, Inc. (NasdaqGS: IRTC). On May 30, 2023, the Company disclosed the receipt of a Warning Letter from the FDA regarding 'non-conformities to regulations for medical devices, including medical device reporting requirements, relating to the Company's Zio AT System and medical device quality system requirements,' specifically addressing a series of deficiencies tied to the marketing and capabilities of the Zio AT device that potentially posed a known but undisclosed risk to patients, for example transmission limits of arrhythmia or heart irregularity events. Thereafter, the Company and certain of its executives were sued in a securities class action lawsuit, charging them with failing to disclose material information during the Class Period, violating federal securities laws. Recently, the court denied the Company's motion to dismiss the case in part, allowing the case to continue. KSF's investigation is focusing on whether iRhythm's officers and/or directors breached their fiduciary duties to its shareholders or otherwise violated state or federal laws. If you have information that would assist KSF in its investigation, or have been a long-term holder of iRhythm shares and would like to discuss your legal rights, you may, without obligation or cost to you, call toll-free at 1-833-938-0905 or email KSF Managing Partner Lewis Kahn ( or visit to learn more. About Kahn Swick & Foti, LLC KSF, whose partners include former Louisiana Attorney General Charles C. Foti, Jr., is one of the nation's premier boutique securities litigation law firms. This past year, KSF was ranked by SCAS among the top 10 firms nationally based upon total settlement value. KSF serves a variety of clients, including public and private institutional investors, and retail investors - in seeking recoveries for investment losses emanating from corporate fraud or malfeasance by publicly traded companies. KSF has offices in New York, Delaware, California, Louisiana, Chicago, New Jersey, and a representative office in Luxembourg. TOP 10 Plaintiff Law Firms - According to ISS Securities Class Action Services To learn more about KSF, you may visit
Yahoo
16-05-2025
- Business
- Yahoo
IRTC Q1 Earnings Call: Outperformance Driven by Zio AT and Primary Care Channel Expansion
Medical technology company iRhythm Technologies (NASDAQ:IRTC) reported Q1 CY2025 results topping the market's revenue expectations , with sales up 20.3% year on year to $158.7 million. The company's full-year revenue guidance of $695 million at the midpoint came in 2% above analysts' estimates. Its non-GAAP loss of $0.96 per share was 2.5% below analysts' consensus estimates. Is now the time to buy IRTC? Find out in our full research report (it's free). Revenue: $158.7 million vs analyst estimates of $153.6 million (20.3% year-on-year growth, 3.3% beat) Adjusted EPS: -$0.96 vs analyst expectations of -$0.94 (2.5% miss) Adjusted EBITDA: -$2.64 million vs analyst estimates of -$5.03 million (-1.7% margin, 47.6% beat) The company lifted its revenue guidance for the full year to $695 million at the midpoint from $680 million, a 2.2% increase Operating Margin: -20.5%, up from -28.9% in the same quarter last year Free Cash Flow was -$17.31 million compared to -$61.81 million in the same quarter last year Market Capitalization: $4.5 billion iRhythm's first quarter results were shaped by accelerated adoption of its Zio AT product and increasing penetration in primary care channels. CEO Quentin Blackford pointed to strong demand from both new and existing accounts, as well as record onboarding of healthcare providers, as key contributors to the robust unit volume growth. Management highlighted the growing share of long-term continuous monitoring prescriptions originating from primary care settings, emphasizing early diagnosis benefits and improved clinical outcomes for patients previously unaware of arrhythmias. Looking ahead, the company's updated full-year guidance reflects confidence in continued momentum from both Zio AT and undiagnosed arrhythmia monitoring through innovative channel partners. CFO Daniel Wilson stated, 'Zio AT performance was a primary driver of our guidance raise, while innovative channel partners are contributing but remain an emerging opportunity.' Management acknowledged macroeconomic uncertainty but maintained that operational efficiencies, product mix, and upstream care pathway expansion are expected to drive sustainable growth for the remainder of the year. Management attributed the quarter's performance to expansion in core U.S. markets, increased adoption among primary care providers, and strong uptake of the Zio AT product. The company also referenced momentum in international markets and ongoing operational efficiency initiatives. Zio AT Momentum: The Zio AT mobile cardiac telemetry device saw significant uptake, benefiting from both new and existing account additions. Management believes features like 14-day continuous wear differentiate it versus competitors, driving retention and market share gains within the MCT segment. Primary Care Channel Expansion: Nearly one third of long-term continuous monitoring volumes now originate from primary care physicians, up from the low 20s percent a year and a half ago. Management credits its 'land-and-expand' strategy for enabling earlier detection and diagnosis of cardiac arrhythmias, particularly among patients with comorbidities who might otherwise be undiagnosed. Innovative Channel Partners: Contribution from value-based care partners focused on undiagnosed arrhythmia monitoring increased, though still represents a low single-digit percentage of total volume. Management described this as an early-stage but high-potential growth avenue for expanding the market beyond traditional cardiology. International Progress and Japan Launch: The company launched Zio in Japan, the world's second-largest ambulatory cardiac monitoring market, albeit at reimbursement rates equivalent to existing Holter monitors. iRhythm aims to generate local clinical evidence to secure higher reimbursement in the future. European markets, especially the UK, continued to deliver record volume. Regulatory and Operational Focus: Ongoing remediation and compliance activities with the FDA, including addressing warning letter observations, remain a top corporate priority. Management expects to complete remediation efforts by the end of 2025 and has allocated resources to ensure uninterrupted product supply in light of tariff and supply chain uncertainties. Management's outlook for the year centers on sustaining Zio AT momentum, expanding the primary care channel, and executing on operational efficiency, while navigating macroeconomic and reimbursement risks. Sustained Zio AT Growth: Expectations for continued above-average growth from the Zio AT product underpin revenue guidance, as management anticipates retention of recent share gains and further penetration in existing accounts. Primary Care and Innovative Partnerships: The company plans to deepen its presence in primary care and value-based care channels, aiming to address a broader population of undiagnosed arrhythmia patients and expand the total addressable market. Tariff and Supply Chain Risks: Management highlighted potential headwinds from tariffs on imported components and supply chain disruptions, but indicated mitigation strategies are underway, including building inventory and exploring supply chain adjustments. Pricing actions will be considered as a secondary lever. Allen Gong (JPMorgan): Asked about drivers behind the guidance raise and confidence for the rest of the year. Management cited sustained Zio AT momentum and a robust pipeline from innovative channel partners but emphasized caution in embedding emerging contributions into guidance. Kallum Titchmarsh (Morgan Stanley): Inquired about the stickiness of Zio AT share gains and how this frames expectations for the upcoming Zio MCT launch. CEO Quentin Blackford noted that established relationships in existing accounts and product features were key to customer retention and future cross-selling potential. Macauley Kilbane (William Blair): Sought clarification on the impact of Epic Aura integration for workflow efficiencies and volume growth. Management reported early signs of increased prescribing patterns but stated these benefits are not yet fully factored into guidance. Suraj Kalia (Oppenheimer): Requested more detail on growth across different business segments. CFO Daniel Wilson explained that Zio AT outpaced company average growth, primary care volumes now exceed one third of total, and innovative channel partners contributed a small but growing share. Sam Eiber (BTIG): Asked about strategies to offset tariff impacts, specifically whether price increases were under consideration. Management replied that supply chain adjustments are the primary mitigation strategy, with pricing actions as a secondary option. Looking ahead, the StockStory team will monitor (1) the trajectory of Zio AT adoption and retention in both existing and new accounts, (2) the pace of expansion and volume contribution from primary care and innovative channel partners, and (3) progress on international launches, particularly in Japan and Europe. Execution on FDA remediation milestones and the timeline for filing and approval of the next-generation Zio MCT device will also be closely watched. iRhythm currently trades at a forward EV-to-EBITDA ratio of 78.7×. At this valuation, is it a buy or sell post earnings? The answer lies in our free research report. The market surged in 2024 and reached record highs after Donald Trump's presidential victory in November, but questions about new economic policies are adding much uncertainty for 2025. While the crowd speculates what might happen next, we're homing in on the companies that can succeed regardless of the political or macroeconomic environment. Put yourself in the driver's seat and build a durable portfolio by checking out our Top 5 Growth Stocks for this month. This is a curated list of our High Quality stocks that have generated a market-beating return of 176% over the last five years. Stocks that made our list in 2020 include now familiar names such as Nvidia (+1,545% between March 2020 and March 2025) as well as under-the-radar businesses like the once-small-cap company Comfort Systems (+782% five-year return). Find your next big winner with StockStory today. Sign in to access your portfolio
Yahoo
01-05-2025
- Business
- Yahoo
iRhythm (NASDAQ:IRTC) Surprises With Strong Q1, Full-Year Sales Guidance is Optimistic
Medical technology company iRhythm Technologies (NASDAQ:IRTC) reported Q1 CY2025 results beating Wall Street's revenue expectations , with sales up 20.3% year on year to $158.7 million. The company's full-year revenue guidance of $695 million at the midpoint came in 2% above analysts' estimates. Its non-GAAP loss of $0.95 per share was 1.5% below analysts' consensus estimates. Is now the time to buy iRhythm? Find out in our full research report. Revenue: $158.7 million vs analyst estimates of $153.6 million (20.3% year-on-year growth, 3.3% beat) Adjusted EPS: -$0.95 vs analyst expectations of -$0.94 (1.5% miss) Adjusted EBITDA: -$2.64 million vs analyst estimates of -$5.03 million (-1.7% margin, 47.6% beat) The company lifted its revenue guidance for the full year to $695 million at the midpoint from $680 million, a 2.2% increase Operating Margin: -20.5%, up from -28.9% in the same quarter last year Market Capitalization: $3.41 billion "The first quarter of 2025 demonstrated continued commercial momentum, with revenue growth exceeding 20% year-over-year, driven by upstream expansion in the patient care pathway and strength in our Zio AT business," said Quentin Blackford, President and Chief Executive Officer of iRhythm. Pioneering the shift from bulky, short-term heart monitors to sleek, wire-free patches, iRhythm Technologies (NASDAQ:IRTC) provides wearable cardiac monitoring devices and AI-powered analysis services that help physicians detect and diagnose heart rhythm disorders. A company's long-term sales performance is one signal of its overall quality. Any business can put up a good quarter or two, but many enduring ones grow for years. Thankfully, iRhythm's 21.9% annualized revenue growth over the last five years was excellent. Its growth beat the average healthcare company and shows its offerings resonate with customers. Long-term growth is the most important, but within healthcare, a half-decade historical view may miss new innovations or demand cycles. iRhythm's annualized revenue growth of 19.9% over the last two years is below its five-year trend, but we still think the results suggest healthy demand. This quarter, iRhythm reported robust year-on-year revenue growth of 20.3%, and its $158.7 million of revenue topped Wall Street estimates by 3.3%. Looking ahead, sell-side analysts expect revenue to grow 14.4% over the next 12 months, a deceleration versus the last two years. Despite the slowdown, this projection is commendable and indicates the market is baking in success for its products and services. Here at StockStory, we certainly understand the potential of thematic investing. Diverse winners from Microsoft (MSFT) to Alphabet (GOOG), Coca-Cola (KO) to Monster Beverage (MNST) could all have been identified as promising growth stories with a megatrend driving the growth. So, in that spirit, we've identified a relatively under-the-radar profitable growth stock benefiting from the rise of AI, available to you FREE via this link. iRhythm's high expenses have contributed to an average operating margin of negative 23.9% over the last five years. Unprofitable healthcare companies require extra attention because they could get caught swimming naked when the tide goes out. It's hard to trust that the business can endure a full cycle. On the plus side, iRhythm's operating margin rose by 4.7 percentage points over the last five years, as its sales growth gave it operating leverage. This performance was mostly driven by its recent improvements as the company's margin has increased by 6.6 percentage points on a two-year basis. In Q1, iRhythm generated a negative 20.5% operating margin. The company's consistent lack of profits raise a flag. Revenue trends explain a company's historical growth, but the long-term change in earnings per share (EPS) points to the profitability of that growth – for example, a company could inflate its sales through excessive spending on advertising and promotions. iRhythm's earnings losses deepened over the last five years as its EPS dropped 5.5% annually. We tend to steer our readers away from companies with falling EPS, where diminishing earnings could imply changing secular trends and preferences. If the tide turns unexpectedly, iRhythm's low margin of safety could leave its stock price susceptible to large downswings. In Q1, iRhythm reported EPS at negative $0.95, up from negative $1.23 in the same quarter last year. Despite growing year on year, this print slightly missed analysts' estimates. Over the next 12 months, Wall Street expects iRhythm to improve its earnings losses. Analysts forecast its full-year EPS of negative $2.80 will advance to negative $1.47. We enjoyed seeing iRhythm beat analysts' revenue and EBITDA expectations this quarter. We were also glad its full-year revenue guidance exceeded Wall Street's estimates. On the other hand, its EPS slightly missed. Overall, we think this was a solid quarter with some key areas of upside. The stock traded up 4.6% to $114.01 immediately following the results. iRhythm put up rock-solid earnings, but one quarter doesn't necessarily make the stock a buy. Let's see if this is a good investment. What happened in the latest quarter matters, but not as much as longer-term business quality and valuation, when deciding whether to invest in this stock. We cover that in our actionable full research report which you can read here, it's free.
