Latest news with #BreakthroughDevice
Cision Canada
20-05-2025
- Business
- Cision Canada
Pulnovo Medical Welcomes EQT as a New Investor Following CE-MDR Approval, with Continued Support from Qiming Venture Partners
HONG KONG, May 20, 2025 /CNW/ -- Pulnovo Medical, a globally recognized pioneer in medical devices for pulmonary hypertension (PH) and heart failure (HF), has received new investment from EQT Group, a top-tier global private equity firm, as a new investor, alongside continued support from Qiming Venture Partners. This latest investment, following Pulnovo Medical's recent CE-MDR certification in Europe, marks a major step forward in expanding treatment options for patients with pulmonary hypertension globally. It is expected to accelerate the company's global expansion by supporting international clinical trials, regulatory approvals, indication expansion, and commercialization. Founded in 2013, Pulnovo Medical addresses a critical unmet need in cardiovascular care by developing a first-in-class medical device based on pulmonary artery denervation (PADN) core technology. It was awarded US FDA Breakthrough Device designation in 2021 and FDA Humanitarian Use Device designation in 2023. Its catheter and generator received China NMPA Approval as a breakthrough device in late 2023, followed by FDA clearance of the 9F sheath in 2024. In March 2025, the company obtained CE-MDR certification, marking a key milestone toward global commercialization. Zoe Zhu, Director in the EQT Private Capital Asia advisory team said: "Globally there is a significant unmet clinical need for patients with pulmonary hypertension and heart failure, Pulnovo's PADN solution offers new hopes for these patients with strong clinical evidence supporting improved outcomes and growing endorsement from the global medical community. EQT is excited to support Pulnovo Medical by leveraging our deep expertise in healthcare and life sciences, along with our global network, to help advance their mission of delivering novel cardiovascular solutions to patients in need worldwide." Cynthia Chen, Chairwoman and Executive Chair of Pulnovo Medical, stated: "We sincerely thank EQT and Qiming Venture Partners for their continued trust and partnership. Since day one, Pulnovo Medical has remained focused on addressing real, unmet clinical needs—developing original, scalable, and evidence-based solutions rooted in frontline care. While the path to transforming clinically driven innovation into global standards is challenging, we remain committed to delivering meaningful, science-based medical value to patients around the world."
Associated Press
17-05-2025
- Health
- Associated Press
Fujirebio Receives Marketing Clearance for Lumipulse® G pTau 217/ β-Amyloid 1-42 Plasma Ratio In-vitro Diagnostic Test as an Aid to Identify Patients With Amyloid Pathology Associated With Alzheimer's Disease
MALVERN, Pa., & TOKYO--(BUSINESS WIRE)--May 17, 2025-- Fujirebio today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company's Lumipulse ® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test for the assessment of amyloid pathology in patients being evaluated for Alzheimer's disease and other causes of cognitive decline. The test, which was granted Breakthrough Device Designation by the FDA, is the first FDA cleared blood-based IVD test in the U.S. to aid to identify patients with amyloid pathology associated with Alzheimer's Disease (AD). Alzheimer's disease currently affects an estimated 7.2 million Americans, a number projected to rise to nearly 14 million by 2060. 1 It is a leading cause of disability and death. AD develops over many years, long before symptoms are evident, but the lack of accessible, minimally invasive diagnostics results in many patients remaining undiagnosed until the disease is well advanced, when few effective interventions remain. The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test is an accurate, minimally invasive, accessible measurement of pTau 217 and β-Amyloid 1-42 concentrations in plasma as a proxy for the presence of β-Amyloid plaque pathology in the brain. It is intended for use in adult patients aged 50 years and older presenting at a specialized care setting with signs and symptoms of cognitive decline. In a clinical study population of 499 patients, which closely mirrored the US demographics, and when applying a dual cut point, the test demonstrated a positive predicate value (PPV) of 92%, a negative predicate value (NPV) of 97% with only 20% patients who are uncertain to have amyloid pathology, thus requiring further testing. The Lumipulse pTau 217/ β-Amyloid 1-42 Plasma Ratio test uses Fujirebio's fully automated LUMIPULSE ® G1200 instrument system, which is widely available in clinical laboratories throughout the U.S. The new ratio test complements the Lumipulse G β-Amyloid Ratio (1-42/1-40), authorized by the FDA for use in CSF in May 2022. 'The lack of effective, accessible and minimally invasive diagnostics for AD contributes to its late diagnosis and inadequate treatment,' says Monte Wiltse, President and CEO at Fujirebio Diagnostics, Inc. 'The Lumipulse G pTau 217/ β-Amyloid 1-42 Plasma Ratio test will go a long way to assist physicians and patients to obtain an AD diagnosis in early stages of the disease, when interventions are more effective. As part of our worldwide commitment to improve the diagnosis and treatment of AD, Fujirebio is developing additional assays, which will increase the availability of diagnostic tools and expand the foundation for early, more effective treatment.' About Fujirebio Fujirebio, a member of H.U. Group Holdings Inc., is a global leader in the field of high-quality in vitro diagnostics (IVD) testing. It has more than 50 years' accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products. Fujirebio was the first company to develop and market CSF biomarkers under the Innogenetics brand over 25 years ago. Fujirebio offers a comprehensive line-up of manual and fully automated assays for neurological diseases and consistently partners with organizations and clinical experts across the world to develop new pathways for earlier, easier and more complete neurodegenerative diagnostic tools. More information can be found at About Fujirebio Diagnostics, Inc. Fujirebio Diagnostics, Inc., a wholly-owned subsidiary of Fujirebio Holdings, Inc., is the premier cancer diagnostics company and the industry leader in cancer biomarker assays. The company pioneered and introduced the CA125 test, the first FDA-approved ovarian cancer biomarker, over 25 years ago. Fujirebio Diagnostics specializes in the clinical development, manufacturing and commercialization of in-vitro diagnostic products for the management of human disease states, with an emphasis in oncology. For more information about Fujirebio Diagnostics, please call +1 610-240-3800 or visit us at Reference 1. (2025), 2025 Alzheimer's disease facts and figures. Alzheimer's Dement., 21: e70235. View source version on CONTACT: MEDIA CONTACT:Chris Dague Fujirebio Diagnostics, Inc. Office: 484-395-5556 [email protected] KEYWORD: UNITED STATES NORTH AMERICA ASIA PACIFIC PENNSYLVANIA INDUSTRY KEYWORD: GENETICS HEALTH NEUROLOGY MEDICAL DEVICES SOURCE: FUJIREBIO Copyright Business Wire 2025. PUB: 05/17/2025 02:58 AM/DISC: 05/17/2025 02:57 AM
Business Wire
15-05-2025
- Business
- Business Wire
Adagio Medical Reports First Quarter 2025 Results
BUSINESS WIRE)--Adagio Medical Holdings, Inc. (Nasdaq: ADGM) ('Adagio' or 'the Company'), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced financial results for the first quarter ended March 31, 2025. Recent Business Highlights: Received Breakthrough Device Designation from the U.S. Food and Drug Administration (the 'FDA') for the vCLAS™ Cryoablation System ('vCLAS'), for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia ('VT') in patients with ischemic or non-ischemic structural heart disease. The vCLAS TM Cryoablation System is currently the subject of the FULCRUM-VT Investigational Device Exemption ('IDE') study designed to support FDA approval. The Breakthrough Device program allows for the FDA to potentially provide Adagio with priority review and interactive communication during the vCLAS TM review phase. Surpassed 50% enrollment in the FULCRUM-VT pivotal study. The study, which seeks to enroll 206 patients with ischemic and non-ischemic disease at 20 U.S. and Canadian centers, is on track for completion of patient enrollment in the second half of 2025. Adagio's Ultra-Low Temperature Cryoablation ('ULTC') and vCLAS technologies were showcased by leading electrophysiologists during multiple scientific sessions at the recent European Heart Rhythm Association (EHRA) and Heart Rhythm Society (HRS) industry meetings. Hired industry veteran Deborah Kaster, who has more than 25 years of leadership experience in the medical technology sector, as Chief Business Officer. Implemented a corporate prioritization initiative focusing all resources on the FULCRUM-VT clinical trial activities and the Company's new product design optimization program, which has been designed to advance faster innovation and iteration to meet market demands. 'This has been a defining quarter for Adagio Medical and for our progress across the company. The FDA's Breakthrough Device Designation, multiple impactful presentations at leading industry conferences, the introduction of our optimized smaller, faster next generation ULTC technology in development and the continued momentum in enrolling patients in our FULCRUM-VT trial all underscore the clinical promise and growing validation of our proprietary ULTC platform technology,' said Todd Usen, Chief Executive Officer of Adagio. 'I am so proud of the Adagio team's accomplishments as we remain resolute in our mission to transform patient treatment and outcomes with our purpose-built solution for the large, underserved population of patients suffering from ventricular tachycardia.' First Quarter 2025 Financial Results Cost of revenue was $0.3 million for the three months ended March 31, 2025, compared to $0.5 million for the three months ended March 31, 2024. Research and development expenses were $3.7 million for the three months ended March 31, 2025, compared to $3.5 million for the three months ended March 31, 2024. Selling, general and administrative expenses were $3.5 million for the three months ended March 31, 2025, compared to $4.8 million for the three months ended March 31, 2024. Net loss for the three months ended, March 31, 2025 was $7.7 million, or $(0.50) per share, compared to a net loss of $8.0 million, or $(10.28) per share, for the three months ended, March 31, 2024. Reported cash and cash equivalents of $13.0 million as of March 31, 2025. About Adagio Medical Holdings, Inc. Adagio is a medical device company focused on developing and commercializing products for the treatment of cardiac arrhythmias utilizing its novel, proprietary, catheter-based Ultra-Low Temperature Cryoablation (ULTC) technology. ULTC is designed to create large, durable lesions extending through the depth of both diseased and healthy cardiac tissue. The Company is currently focused on the treatment of ventricular tachycardia (VT) with its purpose-built vCLAS™ Cryoablation System which is CE Marked and is currently under evaluation in the Company's FULCRUM-VT U.S. IDE Pivotal Study. About FULCRUM VT FULCRUM-VT (Feasibility of Ultra-Low Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia) is a prospective, multi-center, open-label, single-arm study, enrolling 206 patients with structural heart disease of both ischemic and non-ischemic cardiomyopathy, indicated for catheter ablation of drug refractory VT in accordance with current treatment guidelines. The results of the study will be used to apply for FDA premarket approval (PMA) for Adagio's vCLAS™ Cryoablation System, potentially leading to the broadest industry indication for purely endocardial ablation of scar-mediated VT. Adagio's vCLAS™ Cryoablation System is commercially available for the treatment of monomorphic ventricular tachycardia in Europe and select other geographies but is limited to investigational use in the United States. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as 'anticipates,' 'believes,' 'expects,' 'intends,' 'projects,' 'plans,' and 'future' or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning: the potential of our vCLAS™ Cryoablation System; our research, development and regulatory plans for our product candidates, including the timing of initiating additional trials and reporting data from our trials; the regulatory pathway for our vCLAS™ Cryoablation System and the potential impacts of the Breakthrough Device Designation; the potential for our product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies; and our current cash resources and the impacts of our corporate prioritization initiative and realignment of resources. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ('SEC') filings, including in our Annual Report on Form 10-K for the full-year ended December 31, 2024, which is available on the SEC's website at Additional information will be made available in other filings that we make from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law. Condensed Statements of Operations Three Months Ended March 31 2025 2024 Revenue $ — $ 26 Cost of revenue 253 542 Research and development 3,659 3,469 Selling, general, and administrative 3,485 4,830 Total cost of revenue and operating expenses 7,397 8,841 Loss from operations (7,397) (8,815) Other (income) expenses: Convertible notes fair value adjustment 190 1,673 Warrant liabilities fair value adjustment 38 (80) Interest expense (662) (754) Interest income 164 1 Other income (expense), net (46) (43) Total other income, net (316) 797 Net loss $ (7,713) $ (8,018) Basic net loss per share $ (0.50) $ (10.28) Diluted net loss per share $ (0.51) $ (10.28) Weighted-average shares outstanding, basic and diluted 15,375,521 779,908 Expand
Yahoo
13-05-2025
- Health
- Yahoo
GE HealthCare and Raydiant Oximetry accelerate innovation in fetal oxygen saturation technology
The companies plan to co-develop solutions that support the integration of Raydiant Oximetry's fetal pulse oximetry technology into GE HealthCare's fetal monitoring and digital perinatal surveillance platforms that have a 60-year history of innovation and industry firsts. Fetal pulse oximetry technology aims to provide real-time insights to clinicians during labor and delivery and improve the detection of fetal distress, potentially reducing newborn neurological injuries, emergency cesarean sections and improving healthcare costs. Expanding fetal monitoring to include oxygen saturation could support clinicians in improving the standard of care by providing a more comprehensive view of fetal well-being. CHICAGO & SAN RAMON, Calif., May 13, 2025--(BUSINESS WIRE)--GE HealthCare (Nasdaq: GEHC) and Raydiant Oximetry, Inc. today announced a joint development initiative to enhance fetal monitoring capabilities that could strengthen the support of clinical decision-making during labor. This effort leverages the combined expertise and technology of the two companies to advance fetal oxygen saturation monitoring technology with the goal of enhancing the detection of fetal distress during childbirth. Incorporating oxygen saturation into fetal monitoring can help improve measurements of fetal distress and enhance clinician confidence when making critical decisions during labor by providing a more comprehensive view of fetal well-being. Additionally, improving clinicians' evaluation of fetal status may help reduce emergency cesarean section rates, which have been steadily increasing worldwide over the last few decades beyond levels considered medically necessary.i "We are enthusiastic about the potential of our fetal pulse oximetry technology to improve the identification of fetal distress and the opportunity to improve outcomes for mothers and babies during childbirth," said Neil P. Ray, MD, Founder and CEO of Raydiant Oximetry. "GE HealthCare's deep knowledge of the fetal monitoring space will help us advance this technology that aims to transform the standard of care in fetal monitoring." Raydiant Oximetry has developed fetal pulse oximetry solutions to improve the detection of fetal distress during childbirth by measuring fetal blood oxygen saturation. In initial preclinical and clinical studies, Raydiant Oximetry has demonstrated that fetal pulse oximetry could improve the sensitivity and specificity for detecting fetal distress during labor and delivery, and potentially reduce newborn neurological injury rates, emergency cesarean section delivery rates and healthcare costs associated with Raydiant Oximetry has received United States Food and Drug Administration (FDA) Breakthrough Device Designation for expedited review by the FDA, and FDA approval for an Investigational Device Exemption (IDE) to conduct an Early Feasibility Study (EFS) of 30 pregnant women during labor and delivery. The initiation of the GE HealthCare and Raydiant Oximetry effort follows the completion of the EFS IDE clinical study. "Together with Raydiant Oximetry, we are proud to be at the forefront of this technology to help clinicians better manage the complexities of perinatal care," said Larry Boyd, general manager, maternal infant care, GE HealthCare. "We are excited about the potential of this technology to complement our current perinatal portfolio and help us enable care that can support every pivotal moment in labor and delivery, for every family and baby." Through this initiative, the companies plan to co-develop solutions that support the integration of Raydiant Oximetry's fetal pulse oximetry technology into GE HealthCare's fetal monitoring and digital perinatal surveillance platforms. The terms of the agreement have not been disclosed. About GE HealthCare Technologies Inc. GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected and compassionate care, while simplifying the patient's journey across care pathways. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits. GE HealthCare is proud to be among 2025 Fortune World's Most Admired Companies™. Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website for more information. About Raydiant Oximetry, Inc. Raydiant Oximetry is a venture-backed, clinical-stage medical technology company dedicated to improving outcomes for mothers and babies during childbirth. The company was founded by Neil P. Ray, MD, a pediatric anesthesiologist, to address large unmet clinical needs in labor & delivery and improve outcomes for both mother and baby. Raydiant Oximetry has been supported by the Bill & Melinda Gates Foundation, March of Dimes, National Institutes of Health, National Science Foundation, and leading venture capital funds dedicated to improving women's health. iWorld Health Organization. Infographic: Unnecessary Caesarean Section. Accessed April 23, 2025. iiRaydiant Oximetry data on file. View source version on Contacts GE HealthCare Media Contact: Kimberly SchmohlM +1 929 289 Raydiant Oximetry Media Contact: Denise MalvehyM +1 650 822 Sign in to access your portfolio
Time of India
02-05-2025
- Business
- Time of India
Neuralink receives Breakthrough Device Designation from FDA, Elon Musk's sends congratulations to the team
Elon Musk's neurotechnology company, Neuralink has received a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its speech restoration device . The company took to X to post about this achievement. 'We've received Breakthrough Device Designation from the FDA to help restore communication for individuals with severe speech impairment,' posted the company on X. The company also claims that the device would help the people who are affected by amyotrophic lateral sclerosis (ALS), stroke, spinal cord injury, cerebral palsy, multiple sclerosis, and other neurological conditions. Elon Musk also took to X to congratulate the Neuralink team for this achievement. Neuralink's new device a game-changer for speech restoration Neuralink revealed that its new device is designed to help people affected by ALS, stroke, spinal cord injuries, cerebral palsy, multiple sclerosis, and other neurological conditions. The company claims that the device will help them regain their ability to communicate. The company also claims that the implant works by identifying nueral signals and translate them into speech. 'If you or someone you love has lost the ability to speak, you can sign up to our Patient Registry today and help shape the future of communication,' posted the company on X. What Elon Musk said about Neuralink's achievement Following the FDA's announcement, Elon Musk took to X to congratulate the Neuralink billionaire replied, 'Congratulations, @Neuralink team!' Elon Musk has long championed the development of brain-machine interfaces , envisioning a future where technology seamlessly integrates with human cognition. The FDA's Breakthrough Device program is designed to expedite the review process for medical devices that offer the potential for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. AI Masterclass for Students. Upskill Young Ones Today!– Join Now
