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Yahoo
6 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
- 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
23-07-2025
- Business
- Yahoo
Respiree Closes US$11.6M Series A Financing Round Led by We Venture Capital and ClavystBio
HOUSTON and SINGAPORE, July 23, 2025 (GLOBE NEWSWIRE) -- Respiree, a health tech company developing artificial intelligence (AI) platforms to manage disease progression across the healthcare continuum, announced the successful closing of a US$11.6 million Series A financing round led by We Venture Capital and ClavystBio. The round also had participation from Adaptive Capital Partners, conversion of note securities from Mayo Clinic's Mayo Foundation for Medical Research and from existing investors including Greenwillow Capital Management, Seeds Capital, and she1K angel investment. Proceeds will support expansion of Respiree's commercial team and U.S. presence, including company headquarters in Houston, Texas, at the Texas Medical Center (TMC) Respiree, with Founder and Chief Executive Officer Dr. Gurpreet Singh at Center 'The digitalization of healthcare offers a powerful opportunity to improve outcomes and efficiency—but without the right tools, it risks overwhelming care systems, especially amid workforce shortages,' said Dr. Gurpreet Singh, Founder and CEO of Respiree. 'What we need is better use of data, not just more data. Our AI solutions enable timely interventions, reduce alarm fatigue, and support care quality. We're now focused on scaling these tools to enhance the entire patient journey—from smarter triage to follow-up.' Respiree's innovative, augmented-AI platform seeks to support quicker, efficient and precise decision making in various healthcare settings by automating patient monitoring, care pathway management and clinical insight delivery. One of its flagship AI models developed during the Mayo Clinic Platform_Accelerate program, where Respiree graduated from, can help healthcare professionals detect patient deterioration earlier – including rapid response calls in general wards and unplanned ICU transfers. Published as a pre-print in The Lancet, this flagship AI model significantly reduced false alarms while maintaining strong sensitivity — outperforming the positive predictive value (PPV) of EPIC's deterioration index by a factor of six (54.9% vs 8%). Respiree is currently in the process of seeking clearance from the US Food and Drug Administration (FDA) for its flagship AI model. The goal is to integrate the model into its platform, 1Bio™, which already incorporates data from electronic health records (EHRs), mobile questionnaires, third party devices and Respiree's proprietary, U.S.-patented, FDA-cleared sensors to provide longitudinal insights into disease trajectories. 'We are very proud to welcome Respiree to the We VC portfolio,' said Louise Warme, Head of We Venture Capital. 'Respiree stands out in the market by providing a patient monitoring AI/ML + hardware solution with incredible performance, but also unmatched understanding and execution of clinical workflow integration. Their scientifically validated data and key partnerships position Respiree for a promising scale-up journey driven by an extremely execution-focused team.' 'ClavystBio's investment in Respiree is central to our strategy of helping companies scale globally from and through Singapore. Their innovative AI-powered monitoring platform is set to enhance patient care and empower clinical teams with actionable insights. This further underscores our commitment to accelerating medtech innovations aimed at improving patient outcomes across care settings,' said Anselm Tan, Digital Health & MedTech Lead, ClavystBio. Respiree's current solutions include: Scalable AI modules designed to be device-agnostic, platform independent and EHR-compatible, with increased precision to identify patient deterioration across patient touchpoints with low false alarms Pathway-management modules designed to automate delivery of standardized care pathways and requirements for nurses and patients to execute Centralized, EHR-agnostic platform connected to a broad range of EHR environments and medical device systems, consolidating continuous real-time analytics and data from multiple sources Connected wearables with configurable acquisition settings for a range of use-cases, capable of capturing a broad range of cardio-respiratory measures 'Respiree has achieved much since Greenwillow Capital Management first invested in February 2022 and continued to support the Company in the convertible notes last year. We are incredibly encouraged by the commercialization of Respiree's products and services in tier-one markets and look forward to being part of Respiree's growth as it continues to transform patient care on a global scale. We very much welcome the new investors We VC, ClavystBio and Adaptive Capital and look forward to working together in Respiree's forward journey,' said Dr. Wong Mun Yew, Managing Partner of Oriza Greenwillow Technology Fund. Founded in Singapore, Respiree is now executing its global strategy to expand into new markets worldwide. Respiree's solutions are currently available in the U.S., Australia, and across Asia-Pacific (APAC). The company recently announced a partnership with Roche Diagnostics to launch pilot programs across the APAC region. The company has also established key international partnerships with leading global healthcare providers to support its expansion across both acute and home healthcare settings. A portion of the Series A funds will be used to strengthen operations with existing channel partners and accelerate the development of new business relationships. Respiree plans to expand its offerings into newer international markets including the Gulf Cooperation Council and Thailand. About RespireeRespiree™ 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). ( About We Venture CapitalWe Venture Capital is a specialized fund, investing globally in diagnostics start-ups, as well as digital solutions and life science tools disrupting diagnostics. Launched 2023, We VC is focused on Series A investments, but also invest Seed and Series B. Being the corporate investment arm of Werfen, a worldwide leader in specialized diagnostics, We Venture Capital is an active investor, leveraging the network and knowledge from Werfen to the benefit of our investments. We are firm believers of technical advancement as a means to improve patient outcomes and revolutionize healthcare. About ClavystBio ClavystBio is a life sciences investor and venture builder established by Temasek to accelerate the commercialization of breakthrough ideas into health impact. We invest and partner with innovators, entrepreneurs and founders to launch and grow global companies from Singapore. Our focus spans therapeutics, digital health and medtech, with an emphasis on first-in-class science and technology. Our collaborative space, Node 1, provides plug-and-play spaces for ventures that have graduated from incubators to progress to their next milestones. By bringing startups together, we foster a vibrant and supportive community. ( About Greenwillow Capital Management The Oriza Greenwillow Technology Fund is a venture capital fund established jointly by Greenwillow Capital Management Pte Ltd, an MAS-licensed fund management company based in Singapore, and Oriza Holdings, an investment firm from China with assets under management exceeding RMB120 billion. The Fund invests in early-stage technology start-ups in Singapore and the fast-growing markets of Southeast Asia, with a primary focus on the smart cities and health-tech sectors. For more information, please visit Press ContactCammy DuongLifeSci Communicationscduong@ A photo accompanying this announcement is available at in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
