Molecular Diagnostic
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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May 12, 2022
Abbott’s Alinity m STI Assay; Phillips’ MR 7700 System; HOYA’s MiYOSMART Spectacle Lens; Magneto’s Pulmonary Embolism Treatment; Owen Mumford and Stevanto Group’s Collaboration Deal; Elekta’s Radiosurgery System-Elekta Esprit
Abbott Receives Regulatory Approval from US FDA for Alinity™ m STI Assay On May 04, 2022, the US Food and Drug Administration (FDA) granted the regulatory approval to Alinity™ m STI Assay developed by Abbott which is capable of simultaneously detecting and differentiating four common sexually trans...
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Dec 23, 2021
Sky Medical’s Geko™ device; Fist Assist Devices obtains Breakthrough Device designation; Edwards obtains FDA approval; BD launched instrument for testing; GE acquires BK Medical; Zynex’ CM-1500; Foldax’s TRIA biopolymer heart valve
Sky receives FDA clearance to market the geko™ device for venous insufficiency and ischemia On December 16, 2021, Sky Medical Technology Ltd, a medical device company, got approval from the US Food and Drug Administration (FDA) 510(k) to market the geko™ device for growing microcirculatory bl...
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