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).
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.
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.
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.
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.
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.
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.
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.
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.
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).