Molecular Diagnostics
Apr 09, 2026
Waters Receives FDA Approval for Advanced HPV Self-Collection and Testing Kit; MedCAD Achieves FDA 510(k) Clearance for AccuStride® Tib/Fib Anatomical Solution; Mercy Medical Center Expands IBD Care with Office-Based Intestinal Ultrasound; BD Introduced Next-Generation TIPS Innovation to Enhance Portal Hypertension Care in the European Union; KingstronBio Completes First ProStyle M® Mitral Valve Implant in Confirmatory Trial; MiRus Launches Enrollment for STAR Randomized Study of Siegel™ TAVR System
Waters Announced the FDA Clearance of the Most Comprehensive At-Home Cervical Cancer Screening Tool, the Onclarity HPV Self-Collection Kit and FDA-Approved HPV Assay On 08 April 2026, Waters Corporation announced that the U.S. Food and Drug Administration had cleared the Onclarity HPV Self-Collection Kit and app...
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Apr 02, 2026
Restore Robotics Secures FDA 510(k) Clearance for Two New da Vinci Xi® Instruments; Medtronic Wins FDA Approval for OmniaSecure™ Defibrillation Lead Enabling Conduction System Pacing; Bebird Introduces EarSight Ultra; BD Introduces AI-Driven Medication Dispensing System in Europe; i-Lumen Scientific Secures FDA IDE Approval to Launch U.S. Enrollment for i-SIGHT2 Dry AMD Trial; Belay Diagnostics Highlights 82% Clinical Impact Rate in CNS Lymphoma Evaluation
Restore Robotics Received FDA 510(k) Clearance for Two Additional da Vinci Xi® Robotic Instruments On 31 March 2026, Restore Robotics announced that it had received an additional 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the remanufacturing of two more da Vinci Xi robotic surgic...
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Mar 26, 2026
LiviWell Receives FDA Clearance for Livi, Pioneering Post-Intercourse Vaginal Care; Medtronic Advances Spine and Cardiac Care with ViaVerte Partnership and FDA Approval of OmniaSecure Lead; ZEISS Broadens Its Ophthalmic Workflow Portfolio in Canada; Starlight Cardiovascular Reports First-Ever Infant Treated with Lifeline Stent System at Cincinnati Children’s Hospital; Belay Diagnostics Highlights 82% Clinical Impact Rate for Summit™ and Vantage™ in CNS Lymphoma
LiviWell Secured FDA Clearance for Livi, Introducing a New Category in Post-Intercourse Vaginal Care On 24 March 2026, LiviWell announced that the U.S. Food and Drug Administration had granted clearance for Livi, a novel device developed to support vaginal health by absorbing semen and other post-intercour...
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Mar 25, 2026
Molecular Diagnostics: Bridging the Gap Between Diagnosis and Treatment
Molecular diagnostics is a rapidly advancing field within laboratory medicine that applies molecular biology techniques to detect and quantify specific DNA or RNA sequences. By enabling earlier detection, greater diagnostic accuracy, and more informed clinical decision-making, these technologies have become indispe...
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Feb 12, 2026
Hologic Gains FDA Clearance for Aptima® HPV Assay as Primary Screening Tool; ZOLL Zenix Monitor/Defibrillator Achieves MDR Approval; Labcorp Unveils FDA-Cleared Blood Test for Alzheimer’s Screening; P&F SecureD EU MDR CE Mark Approval for the TricValve® System; Valcare Medical Performs First U.S. Transseptal AMEND™ Implant as Part of Early Feasibility Study; Hyperfine Unveils New Clinical Results Showing Improved Stroke Detection with the Swoop® System
Hologic Received FDA Approval for Aptima® HPV Assay Primary Screening Option, Expanding Cervical Health Portfolio On February 04, 2026, Hologic, Inc. announced that its Aptima® HPV Assay had received FDA approval for clinician-collected HPV primary screening. The test, which was the only FDA-approved mRNA-...
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Dec 18, 2025
BD Broadens BD MAX™ System Menu with IVDR-Certified VIASURE Assays; OrthAlign Broadens the Lantern® Hip Platform for Posterior Approach Total Hip Arthroplasty; Bioretec Received FDA Breakthrough Device Designation for the Remeos™ Drillpin; Medivis Achieves First FDA Authorization for AR Navigation in Neurosurgery; Cerapedics Publishes 24-Month ASPIRE Clinical Outcomes in Spine Journal; Acumed’s Acu-Loc NEXT System Debuts in First Wrist Fixation Surgery at Duke University Hospital
BD Expanded BD MAX™ System Menu with New IVDR-Certified VIASURE Assays in Partnership with Certest Biotec On December 15, 2025, BD (Becton, Dickinson and Company), a leading global medical technology company, announced the expansion of its respiratory and sexually transmitted infection (STI) diagnostics po...
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Oct 23, 2025
OncoHost Granted New York State Lab Permit, Enabling PROphetNSCLC® Nationwide Access; Onkos Surgical’s ELEOS Proximal Tibia with NanoCept antibacterial surface receives FDA 510(k) clearance; BD’s Simplified At-Home HPV Test to Expand Cervical Cancer Screening Internationally; Oticon’s New Zeal™ Hearing Aid Delivers Discreet Style with Next-Gen AI Sound & Connectivity; Nyra Medical Launches First-in-Human Trial of New Mitral Valve Repair System; Cordis Reveals 12-Month Outcomes from SELUTION SLR DEB Trial
OncoHost Received New York State Laboratory Permit, Expanding Availability of PROphetNSCLC® Precision Oncology Test On October 22, 2025, OncoHost, a technology company transforming the approach to precision medicine through plasma proteomics and AI, announced that it had received a laboratory permit from t...
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Jul 31, 2025
Philips Secures FDA Nod for Image-Guided Platform in Prostate Cancer Treatment; Roche Gains CE Mark for Alzheimer’s Screening Blood Test; CorTec Completes First Human Implantation of Its Brain-Computer Interface in Neurotech Breakthrough; Natera Initiates ABCSG 61 Trial to Assess Signatera™ in Early-Stage Breast Cancer; GE HealthCare Introduces Advanced Digital X-ray System to Enhance Imaging Accessibility in High-Volume Settings; Stryker-Owned Inari Medical Launches InThrill® System for AV-Access and Small Vessel Thrombus Treatment
Philips Secured FDA 510(k) Clearance for Image-Guided Navigation Technology, Advancing Minimally Invasive Prostate Cancer Treatment On July 23, 2025, Philips, a global leader in health technology, announced a significant milestone in prostate cancer care with the U.S. FDA 510(k) clearance of the latest ver...
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Nov 30, 2023
Baird Medical’s Microwave Ablation System; BrainSpec’s AI-Backed Solution for Non-Invasive Brain Chemistry Measurement; AWAK’s AI-Enabled Kidney Disease Prediction Tool; Revvity’s EONIS Q System; FormaPath Announced Advancement in Cancer Pathology; Pramand Launched CraniSeal Dural Sealant
Baird Medical Received the US FDA Clearance for a Microwave Ablation System On November 22, 2023, Baird Medical announced the US Food and Drug Administration clearance of the company’s microwave ablation (MWA) system and disposable needles for use in the US. The clearance allows the use of the technology to a...
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Nov 09, 2023
SIBIONICS’s Ground-breaking GS1 Continuous Glucose Monitoring System; Abbott’s HPV Test to Run on Alinity m; CleanNA’s CE-IVD Molecular Diagnostics Product; Orthofix’s WaveForm L Interbody System; Alucent Biomedical’s AlucentNVS Technology; Surmodics’s TRANSCEND Trial Data
SIBIONICS Received CE Mark for Its Ground-breaking GS1 Continuous Glucose Monitoring System On November 01, 2023, SIBIONICS, the world's third-largest Continuous Glucose Monitoring System (CGM) brand, received the CE Mark for its revolutionary GS1 CGM. This significant milestone marks a momentous achiev...
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