In Vitro Diagnostics
Jul 23, 2026
Seegene USA Advances Infectious Disease Diagnostics with FDA EUA for Multiplex PCR Assay; Synergy Disc® Achieves 100 U.S. Cases Within 100 Days of FDA Approval; Moon Surgical and KARL STORZ Forge Strategic Commercial Alliance to Expand Scalable Surgery; Cepheid to Showcase Third-Generation GeneXpert® System at ADLM 2026; Co-Diagnostics and CoSara Launch Clinical Studies in India for PCR-Based Tuberculosis Test; NeoCast Delivers Strong Clinical Outcomes in Chronic Subdural Hematoma in Final First-in-Human EMBO-02 Study
Seegene USA Received FDA Emergency Use Authorization for Multiplex PCR Assay, Advancing Differential Diagnosis of HSV-1&2, VZV, and Monkeypox Virus for Ulcerative Skin Lesions On 21 July 2026, Seegene USA received U.S. FDA Emergency Use Authorization (EUA) for its Allplex™ HSV-1&2/VZV/MPXV Assay, the fir...
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Mar 11, 2026
Companion Diagnostics in Healthcare: Powering the Era of Precision Medicine
The landscape of modern medicine is undergoing a profound shift from a "one-size-fits-all" approach to a model that is deeply personalized and data-driven. At the heart of this transformation is the concept of precision medicine, which seeks to tailor medical treatment to the individual characteristics of each pati...
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Sep 04, 2025
Geneseeq Technology Inc.’s GENESEEQPRIME® Assay Receives FDA 510(k) Clearance; Medtronic’s MiniMed™ 780G Gains FDA Approval for Abbott Instinct Sensor Integration and Type 2 Diabetes Use; CorNeat Vision’s Artificial Cornea Restores 20/20 Vision for Shingles-Induced Blindness; Johnson & Johnson Reports Favorable Outcomes from Real-World VARIPULSE™ PFA Study at 2025 ESC Congress; SprintRay Strengthens Dental 3D Printing Portfolio with EnvisionTEC Acquisition; Olympus Unveils Latest Imaging Platform for ENT and Urology in the U.S.
Geneseeq Technology Inc. Received FDA 510(k) Clearance for GENESEEQPRIME® Assay On September 02, 2025, Geneseeq Technology Inc. announced that the U.S. Food and Drug Administration (FDA) had granted 510(k) clearance for its GENESEEQPRIME® NGS Tumor Profiling Assay. This in vitro diagnostic (IVD) test kit used ne...
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Aug 25, 2022
Edwards’s Pascal Precision System; Abbott’s New Spinal Cord Stimulation Device; Imagin to Acquire enCAGE Coil Precision Ablation System; Boston Heart Diagnostics Launches LipidSeqTM; Rocket VR Health Partners with Penn Medicine’s Abramson Cancer Center; Thermedical’s Clinical Trial to Treat Ventricular Tachycardia
Edwards Pascal Precision Transcatheter Mitral And Tricuspid Valve Repair System Receives CE Mark On August 17, 2022, Edwards Lifesciences Corporation, an American medical technology company headquartered in Irvine, California, specializes in artificial heart valves and hemodynamic monitoring. The company announc...
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Mar 24, 2022
Smithfield BioScience and BioCircuit’s Nerve Tape Device; Cynosure-Jeisys Medical’s Partnership; bioMérieux’s VITEK® MS PRIME new MALDI-TOF Mass Spectrometry Identification System; Artio Medical’s Gold Embolization Device; Heartpoint Global’s Implant System; ObvioHealth’s Virtual Urogynecology Clinical Trial
Smithfield BioScience and BioCircuit to Develop New Nerve Tape Device On March 16, 2022, BioCircuit Technologies, a National Institutes of Health (NIH)-funded medical device company primarily focused on developing and commercializing tissue repair and neural interfacing products, and Smithfield BioScience, a uni...
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Jan 06, 2022
Siemens Healthineers’s COVID-19 Antigen Self-Test; Paragon’s R3ACT Stabilization System; Pulnovo Medical’s PADN-CFDA trial; Endotronix’s PROACTIVE-HF trial; Abbott’s Proclaim XR SCS System; RTI Surgical spins off businesses
Siemens Healthineers received Emergency Use Authorization for CLINITEST® Rapid COVID-19 Antigen Self-Test by the FDA On December 29, 2021, Siemens Healthineers was granted Emergency Use Authorization (EUA) for its CLINITEST Rapid COVID-19 Antigen Self-Test by the United States Food and Drug Administration ...
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Dec 30, 2021
Cerner, Scanwell Health and Personal Genome Diagnostics Acquisition; Zynex’s Fluid Monitoring System, CM-1500; Sight Sciences’ TearCare System; Envista’s Nobel Biocare N1 Implant System
Oracle Corporation sets to acquire Cerner Corporation On December 20, 2021, Oracle Corporation and Cerner Corporation entered into an agreement as per which Oracle will acquire Cerner through an all-cash tender offer for approximately USD 28.3 billion in equity value. Larry Ellison, Chairman and C...
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