This year’s flu season is shaping up to be a nasty one—driven by a new variant of the influenza virus that may be able to slip past our vaccine defenses. A mutated form of the influenza A strain H3N2 ...

MAHWAH, N.J.--(BUSINESS WIRE)--KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development, manufacturing, and ...

KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and ...

NEW YORK – Italian in vitro diagnostics firm Diasorin said on Sunday that the US Food and Drug Administration has issued 510(k) clearance and CLIA-waived the firm's first assay for use on the Liaison ...

At least 14 states and Washington, DC, are reporting high or very high flu activity. The dominant flu strain, a version of influenza A (H3N2) called subclade K, has multiple mutations that make it ...

Crescom Co. Ltd., an AI musculoskeletal imaging company, gained U.S. FDA 510(k) clearance Dec. 24 for MediAI-BA, its AI-powered pediatric and adolescent bone age analysis software. Classified as a ...

NEW YORK - The US Food and Drug Administration granted 510(k) marketing clearances in November to Roche Molecular Systems, Cytovale, Truvian Health, and others for infectious disease pathogen ...

Globus Medical went into 2025 with a strong foothold in spine and orthopedics, and it’s well-positioned for the next year. Here are 10 key updates: 1. Globus Medical introduced its DuraPro drill with ...

The Food and Drug Administration's White Oak campus in Silver Spring, Maryland. (Maansi Srivastava/ For The Washington Post via Getty Images) Six days after a senior FDA official sent a sweeping ...

The U.S. Food and Drug Administration has granted 510(k) clearance to 3D Systems, allowing its VSP Orthopedics virtual surgical planning and patient-specific instrumentation platform to benefit a ...

Please provide your email address to receive an email when new articles are posted on . The device is the first to gain FDA clearance to monitor delirium. The device’s algorithm was validated with ...

Dental AI company Pearl was granted FDA 510(k) clearance for the detection of dental pathologies on panoramic X-rays. Pearl’s Second Opinion platform is now available to use to identify caries, ...