Defibrillator
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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Feb 01, 2024
Samsung Partnered with Lunit; Boston Scientific Launched VersaVue single-use Flexible Cystoscope; Element Science’s Patch-wearable Cardioverter Defibrillator; BIOCORP Received 510(k) FDA Clearance for SoloSmart; FDA IDE for CroiValve’s Tricuspid Heart Valve; FastWave Medical’s First-in-human Study of its IVL Tech
Samsung partnered with Lunit on AI for Enhanced Chest Screening On January 25, 2024, Samsung entered into a supply collaboration with Lunit, in order to employ its AI-powered technology for conducting chest screenings. The agreement was signed by Boston Imaging, which serves as the U.S. hub for Samsung's d...
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Feb 23, 2023
Medtronic’s Extravascular Defibrillator System; Stryker’s Q Guidance System for Cranial Applications; Synchrony Medical’s LibAirty™ Airway Clearance System Study; Cognito Therapeutics’s Pivotal Study HOPE Update; Dexcom’s G6 Continuous Glucose Monitoring System Launch in Singapore; Rhaeos Raised $10.5M in Series A Funding
Medtronic Received CE Mark for Extravascular Defibrillator System, used to treat Abnormal Heart Rhythms On February 17, 2023, Medtronic plc, the leading global healthcare technology company, received CE mark for the Aurora EV-ICD™ MRI SureScan™ (Extravascular Implantable Cardioverter-Defibrillator)...
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Sep 01, 2022
Miracor Medical’s Picso Pivotal Study; Medtronic’s Extravascular ICD; Galaxy Medical’s CENTAURI Pulsed Electric Field System; UltraSight’s Novel Cardiac AI Technology; Oticon Launched the World’s Smallest Hearing Aid; Medtronic Completes Acquisition of Affera
FDA Approved IDE for Picso® Pivotal Study of Miracor Medical On August 23, 2022, Miracor Medical SA, a provider of innovative solutions for the treatment of severe cardiac diseases, announced that the FDA has approved an Investigational Device Exemption (IDE), allowing the company to begin a pivotal study with i...
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