Healthcare Press Releases
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- Written by: Carl Zeiss Meditec AG
- Category: Press Releases
ZEISS Medical Technology announced today that the MEL® 90 received approval from the U.S. Food and Drug Administration (FDA), giving the excimer laser technology simultaneous approval for all three major indications, including myopia, hyperopia and mixed astigmatism (a condition where both hyperopic and myopic correction is required).
- Company Name: Carl Zeiss Meditec AG
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- About Company: Carl Zeiss Meditec AG (ISIN: DE0005313704), which is listed on the MDAX and TecDAX of the German stock exchange, is one of the world's leading medical technology companies. The Company supplies innovative technologies and application-oriented solutions designed to help doctors improve the quality of life of their patients. The Company offers complete solutions, including implants and consumables, to diagnose and treat eye diseases. The Company creates innovative visualization solutions in the field of microsurgery. With 5,730 employees worldwide, the Group generated revenue of €2,066.1m in fiscal year 2023/24 (to 30 September). The Group's head office is located in Jena, Germany, and it has subsidiaries in Germany and abroad; more than 50 percent of its employees are based in the USA, Japan, Spain and France. The Center for Application and Research (CARIn) in Bangalore, India and the Carl Zeiss Innovations Center for Research and Development in Shanghai, China, strengthen the Company'
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- Written by: Werfen
- Category: Press Releases
Werfen announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the Aptiva® Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Reagents.
- Company Name: Werfen
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- About Company: Werfen (werfen.com) founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company's clinical areas of focus include Autoimmunity, Hemostasis, Acute Care Diagnostics, Transfusion, and Transplant. Werfen's solutions help improve the way patients with autoimmune diseases are diagnosed, monitored, and treated. The autoimmunity portfolio includes Aptiva®, BIO-FLASH®, NOVA View®, and QUANTA-Lyser® 3000 systems, and QUANTA Link® data management solution. The Werfen logo is a trademark of Werfen. Aptiva, QUANTA-Lyser, QUANTA Lite, QUANTA Link, QUANTA Flash, NOVA View, NOVA Lite are registered trademarks of Inova Diagnostics, Inc., a Werfen company. BIO-FLASH is a registered trademark of Biokit S.A. All other product names, company names, marks, logos, and symbols are trademarks of their respect
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- Written by: RespondHealth
- Category: Press Releases
RespondHealth, a real-world evidence clinical discovery company, is pleased to announce a new integration with Microsoft to bring AI-powered solutions to the healthcare and life sciences (HLS) sectors. This collaboration integrates RespondHealth's real-world health data sources, including patient records from over 200 million Americans, with Microsoft Azure OpenAI Service, to help turn complex data into actionable insights.
- Company Name: RespondHealth
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- About Company: RespondHealth, bridges the gap between clinical trials and real-world healthcare by transforming complex datasets into actionable intelligence. Guided by a vision to improve care for every patient and advance research for every disease, we develop AI-powered solutions that empower healthcare leaders to make informed decisions. Our unique blend of expertise in healthcare, epidemiology, advanced analytics, and AI, paired with a collaborative culture, enables us to tackle complex challenges and build tools addressing critical needs in patient care and innovation. Advances in AI have opened doors to possibilities that were once out of reach, and we embrace these advancements to continually refine and expand our capabilities. With access to one of the largest real-world health data lakes, we design solutions that harness the latest technology to further our mission. While we are proud of what we have achieved, we are equally energized by what lies ahead. Each new development in AI inspire
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- Written by: Onera Health
- Category: Press Releases
Onera Health, a leader in transforming sleep medicine and remote monitoring, announced the publication of a multicenter validation study of its Onera Sleep Test System (STS) in the Journal of Clinical Sleep Medicine, the official journal of the American Academy of Sleep Medicine. The study demonstrated that the patch-based Onera STS home-polysomnography (hPSG) performs comparably to gold-standard in-lab polysomnography (PSG) for both sleep staging and respiratory event detection.
- Company Name: Onera Health
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- About Company: Onera Health is a leader in transforming sleep medicine and remote monitoring. Their breakthrough diagnostic solutions and services are poised to help millions of people struggling with sleep-related ailments while also impacting other medical fields by monitoring various chronic conditions, ultimately improving the health and quality of life of patients worldwide. The company’s innovative solutions provide comprehensive sleep test data to physicians in a variety of clinical and non-clinical environments to optimize patient care and reduce healthcare costs. Onera has offices in the Netherlands and the U.S.
- Person of Contact: Swea Ann Hagenhoff
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- Written by: Lunit
- Category: Press Releases
Lunit a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, and Volpara Health, a Lunit company and a global leader in mammography AI for the early detection of cancer, announced their unified vision, focusing on a comprehensive Ecosystem for early cancer detection, cancer risk prediction, and autonomous AI for enhanced clinical workflows.
- Company Name: Lunit
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- About Company: Founded in 2013, Lunit (KRX:328130.KQ) is a medical AI company on a mission to conquer cancer. We harness AI-powered medical image analytics and AI biomarkers to ensure accurate diagnosis and optimal treatment for each cancer patient. The FDA-cleared Lunit INSIGHT suite for cancer screening serves over 4,500 hospitals and medical institutions across 55+ countries. Lunit clinical studies have been published in top journals, including the Journal of Clinical Oncology and the Lancet Digital Health, and presented at global conferences such as ASCO and RSNA. In 2024, Lunit acquired Volpara Health Technologies, setting the stage for unparalleled synergy and accuracy, particularly in breast health and screening technologies. Headquartered in Seoul, South Korea, with a network of offices worldwide, Lunit leads the global fight against cancer.
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- Written by: Nsight
- Category: Press Releases
Nsight Health, a leader in Remote Patient Monitoring (RPM) and Chronic Care Management (CCM), has announced an exciting new partnership with Physicians Choice® Medical, a trusted provider of Billing, Revenue Cycle Management, Credentialing, and Practice Management consulting.
- Company Name: Nsight
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- About Company: Nsight Health is a leader in Remote Patient Monitoring (RPM) and Chronic Care Management (CCM), helping healthcare providers proactively manage patient health. By leveraging advanced technology and personalized care models, Nsight Health enables providers to improve outcomes, reduce costs, and transform care delivery.
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- Written by: Ibex Medical Analytics
- Category: Press Releases
Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, and Institut Curie, France’s globally renowned cancer center, announced the introduction of Ibex’s AI solution in routine clinical practice.
- Company Name: Ibex Medical Analytics
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- About Company: Ibex Medical Analytics is transforming cancer diagnostics with world-leading clinical grade AI-powered solutions for pathology. Empowering physicians and supporting pathologists, Ibex is on a mission to provide accurate, timely and personalized cancer diagnosis for every patient. Ibex is the first and most widely deployed AI-powered platform in pathology. Pathologists worldwide use Ibex as part of their everyday routine to improve the accuracy of cancer diagnosis, implement comprehensive quality control measures, reduce turnaround times, and boost productivity with more efficient workflows. The Ibex suite includes solutions which are for Research Use Only (RUO) in the United States and not cleared by the FDA. Multiple solutions are CE marked (IVDD and IVDR) and registered with the UK MHRA. For more information, including indication for use and regulatory approval in other countries, contact Ibex Medical Analytics.
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- Written by: SHL Medical
- Category: Press Releases
SHL Medical, a world leader in self-injection solutions, plans to establish SHL Advantec – a dynamic sub-group dedicated to providing tooling and automation solutions to the healthcare sector and other industries.
- Company Name: SHL Medical
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- About Company: As a pioneering leader in self-injection solutions, SHL Medical is the partner of choice for many leading pharma and biotech companies. Driven by our company purpose – Enabling Patients' Independence – we offer patient-centric solutions for the design, development, and manufacturing of autoinjectors, pen injectors, as well as innovative specialty delivery systems for large-volume and high-viscosity formulations. We also offer final assembly, labeling, and packaging solutions for our drug delivery systems. In response to the rising trend in home therapy, SHL Medical has increased developmental work in the digital healthcare sector to help improve the drug delivery ecosystem. Located across Switzerland, Taiwan, Sweden, and the US, our global team of experts collaborate seamlessly as one team in utilizing our comprehensive in-house manufacturing capabilities. Our solutions offer customization and optimization for each project while proactively weaving sustainability-driven measures
- Person of Contact: Carl Gillblad
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- Written by: Hyperfine, Inc.
- Category: Press Releases
Hyperfine, Inc. the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared portable magnetic resonance (MR) brain imaging system—the Swoop® system—announced the issuance of new MRI standards by the Intersocietal Accreditation Commission (IAC), a leading CMS-approved accrediting body. The new standards, effective immediately, now include portable MR scanning at the point of care.
- Company Name: Hyperfine, Inc.
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- About Company: Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care.
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- Written by: Novoxel Inc.
- Category: Press Releases
Novoxel Inc. announces the U.S. FDA clearance of the Tixel i (pronounced "Tixel Eye") for sale in the USA.The newest member of the Tixel family of products was cleared for application of localized heat and pressure for patients with Evaporative Dry Eye due to Meibomian Gland Dysfunction (MGD).
- Company Name: Novoxel Inc.
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- About Company: Established in 2011, Novoxel Ltd. focuses on scientific and clinical innovation. Novoxel has been granted numerous patents around the world, including USA, EU, UK, Japan, Israel, Korea, and China. The company's Tixel family of products use proprietary Thermo-Mechanical Action (TMA®) to deliver noticeable clinical results even though treatments are non-invasive. There is minimal downtime, no expensive single-use cartridges, no bleeding, and minimal/no pain. Because the affordable treatments are radiation-free, safety eyewear is not required for clinicians. ©2024, Novoxel Inc. All rights reserved. Novoxel, Tixel, Tixel 2, Thermo-Mechanical Action, and TMA are all registered trademarks of Novoxel Ltd. Simple Relief is a trademark of Novoxel Inc.
- GT Metabolic™ completes first U.S. cases with FDA-cleared MagDI™ System
- FDA Grants De Novo Authorization to OMRON Healthcare for New Blood Pressure Monitors with AI-Powered AFib Detection Feature
- Shockwave Medical reveals initial clinical outcomes for its new IVL platform
- Medtronic gains FDA approval for its Affera™ Mapping and Ablation System with the Sphere-9™ Catheter, marking a breakthrough in electrophysiology
- Okomera secures €1.5M grant to advance microfluidics and AI-powered CRISPR editing for target validation