Latest news with #FDAclearance
Yahoo
5 days ago
- Health
- Yahoo
Respiree Secures Second FDA 510(k) Clearance, Expands Cardio-Respiratory Wearable to Home Use via 1Bio™ Connected Care Platform
HOUSTON and SINGAPORE, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Respiree, a health tech company developing artificial intelligence (AI) platforms to manage disease progression across the healthcare continuum, today announced it has received its second U.S. Food and Drug Administration (FDA) 510(k) clearance. The clearance expands the use of its RS001 cardio-respiratory wearable to home environments and includes approval for its connected care platform marketed as 1Bio™. Illustrative Image of Respiree's RS001 Wearable With its Connected Care 1Bio™ Platform The RS001 is a chest-worn device that directly measures respiration and offers passive cardio-respiratory monitoring. Originally cleared for in-patient clinical use, the RS001's use in home settings marks a significant step toward more accessible and preventive healthcare. The device connects to a cellular hub, which enables data to be visualized in real time via the connected care 1Bio™ dashboard. 'Respiration is the most predictive vital sign for clinical deterioration, yet it remains underutilized – particularly outside hospital settings,' said Dr. Gurpreet Singh, CEO and Founder of Respiree. 'This FDA 510(k) extension allows healthcare systems to passively and accurately monitor leading indicators in the home, enabling earlier interventions and reducing the overall burden on healthcare infrastructure.' The announcement follows Respiree's recent US$11.6 million Series A financing round, led by We Venture Capital and ClavystBio, which will accelerate development toward potential regulatory approvals and global market expansion. Respiree also announced plans to pursue additional FDA clearances for its proprietary AI software, aiming to integrate artificial intelligence models into the 1Bio™ platform for both inpatient and home-based care. 'These are exciting times for us,' added Dr. Singh. 'Our first 510(k) was for the wearable; this second one is for the platform. We are now focused on bringing our flagship AI models into the fold as a Software as a Medical Device (SaMD).' About Respiree Respiree™ is an AI/ML health tech company building state-of-the-art clinically-validated artificial intelligence (AI) for managing disease progression across healthcare's care continuum. The 1Bio™ platform by Respiree™ uses data from the EHR and its proprietary US-patented and FDA-cleared sensors to longitudinal measure and track disease progression. Respiree™ is now available in U.S., Australia and Asia-Pacific (APAC). Respiree™ is CE marked, has received regulatory clearances in Australia from the Therapeutics Goods Administration and has received the 510k clearance from the United States Food and Drug Administration (FDA). ( Media Enquiries Evangeline FuAdministrative ManagerRespiree Pte LtdEmail: evangeline@ A photo accompanying this announcement is available at in to access your portfolio
Yahoo
5 days ago
- Health
- Yahoo
Respiree Secures Second FDA 510(k) Clearance, Expands Cardio-Respiratory Wearable to Home Use via 1Bio™ Connected Care Platform
HOUSTON and SINGAPORE, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Respiree, a health tech company developing artificial intelligence (AI) platforms to manage disease progression across the healthcare continuum, today announced it has received its second U.S. Food and Drug Administration (FDA) 510(k) clearance. The clearance expands the use of its RS001 cardio-respiratory wearable to home environments and includes approval for its connected care platform marketed as 1Bio™. Illustrative Image of Respiree's RS001 Wearable With its Connected Care 1Bio™ Platform The RS001 is a chest-worn device that directly measures respiration and offers passive cardio-respiratory monitoring. Originally cleared for in-patient clinical use, the RS001's use in home settings marks a significant step toward more accessible and preventive healthcare. The device connects to a cellular hub, which enables data to be visualized in real time via the connected care 1Bio™ dashboard. 'Respiration is the most predictive vital sign for clinical deterioration, yet it remains underutilized – particularly outside hospital settings,' said Dr. Gurpreet Singh, CEO and Founder of Respiree. 'This FDA 510(k) extension allows healthcare systems to passively and accurately monitor leading indicators in the home, enabling earlier interventions and reducing the overall burden on healthcare infrastructure.' The announcement follows Respiree's recent US$11.6 million Series A financing round, led by We Venture Capital and ClavystBio, which will accelerate development toward potential regulatory approvals and global market expansion. Respiree also announced plans to pursue additional FDA clearances for its proprietary AI software, aiming to integrate artificial intelligence models into the 1Bio™ platform for both inpatient and home-based care. 'These are exciting times for us,' added Dr. Singh. 'Our first 510(k) was for the wearable; this second one is for the platform. We are now focused on bringing our flagship AI models into the fold as a Software as a Medical Device (SaMD).' About Respiree Respiree™ is an AI/ML health tech company building state-of-the-art clinically-validated artificial intelligence (AI) for managing disease progression across healthcare's care continuum. The 1Bio™ platform by Respiree™ uses data from the EHR and its proprietary US-patented and FDA-cleared sensors to longitudinal measure and track disease progression. Respiree™ is now available in U.S., Australia and Asia-Pacific (APAC). Respiree™ is CE marked, has received regulatory clearances in Australia from the Therapeutics Goods Administration and has received the 510k clearance from the United States Food and Drug Administration (FDA). ( Media Enquiries Evangeline FuAdministrative ManagerRespiree Pte LtdEmail: evangeline@ A photo accompanying this announcement is available at in to access your portfolio
Yahoo
6 days ago
- Business
- Yahoo
iRadimed Corp (IRMD) Q2 2025 Earnings Call Highlights: Record Revenues and Strategic Product ...
Release Date: August 01, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points iRadimed Corp (NASDAQ:IRMD) reported its 16th consecutive quarter of record revenues, achieving $20.4 million in Q2 2025, a 14% increase over the same period last year. Gross profit remained strong at 78%, with GAAP diluted earnings per share increasing by 18% from Q2 2024. The company successfully launched its new 3,870 IV pump system, which received FDA clearance, marking a significant milestone. Domestic sales increased by 18%, contributing to 89% of total revenue for Q2 2025. The company raised its full-year 2025 revenue guidance to $80 to $82.5 million, reflecting strong first-half performance. Negative Points International sales decreased by 9% to $2.2 million, indicating challenges in global markets. Operating expenses increased by 9% due to higher sales and marketing costs, impacting overall profitability. The transition to a new facility is expected to cause short-lived operational inefficiencies. The backlog for pump orders is running about 5 to 6 months, which could delay revenue realization. Anticipated bookings for pumps are expected to be low in Q1 2026 due to the transition to the new pump model. Q & A Highlights Warning! GuruFocus has detected 5 Warning Sign with IRMD. Q: Can you discuss the current backlog and how you expect the sales of the 3,860 pumps to trend before the launch of the 3,870? A: Unidentified_3 (CFO): We have a record backlog as of June 30, composed of both pumps and strong monitoring backlog. This gives us good visibility into the second half of the year. We expect strong sales of the 3,860 pumps until we start promoting the 3,870 in December. Unidentified_2 (CEO): The 3,860 orders remain strong, and we control how they will trail off. We plan to start discussing the 3,870 in December, so 3,860 sales should remain significant until then. Q: How do you anticipate the ramp-up to $50 million in pump revenue with the 3,870? A: Unidentified_2 (CEO): We plan to sell a few 3,870s in Q4 for feedback rather than revenue. Full sales efforts will begin around New Year's. Initial bookings will be low, but revenue will remain strong due to the backlog. By Q2, we expect a strong run rate, accelerating through Q3 and Q4, aiming for a $100 million revenue run rate by the end of 2026. Q: Do you think the improvements in the 3,870 could expand the overall market demand for pumps? A: Unidentified_2 (CEO): The 3,870 is a significant improvement over the old pump, especially in usability, with a modern interactive user interface. We believe this will accelerate adoption among those who were hesitant with the older model. This potential market expansion is not factored into our current projections, so it represents upside potential. Q: Is there an anticipated increase in the average selling price (ASP) for the new pump? A: Unidentified_2 (CEO): Yes, we anticipate the ASP for the new pump to be about 12% higher than the existing pump. This increase should positively impact gross margins and potentially operating margins as well. Q: How long is it currently taking to fulfill your backlog, and what is the timing from order to fulfillment? A: Unidentified_2 (CEO): The monitor backlog is about 4-5 weeks, while the pump backlog is around 5-6 months. We expect pump bookings to be low in Q1 due to the transition, but revenue will remain strong due to the existing backlog. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
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.
