Magnetic Resonance Imaging Devices
Sep 24, 2026
Powerful Medical’s AI ECG Technology Earns FDA De Novo Authorization for Heart Attack Detection; Werfen Secures US FDA 510(k) Clearance and CE Mark for Aptiva® APS IgA Reagent; Ontario Introduces Fetal Blood Type Screening to Improve Pregnancy Care; Medvue Concorde Acquires Next-Generation AI-Powered MRI System; Cardiol Therapeutics Hits Phase III MAVERIC Enrollment Target Early and Expands Pivotal Trial for CardiolRx; Ferronova Reports Preliminary MAGMAP Results in 62-Patient Gastric and Oesophageal Cancer Trial
Powerful Medical Receives FDA De Novo Authorization for AI-Based ECG Model for Acute Heart Attack Detection On 15 September 2026, Powerful Medical announced that the U.S. Food and Drug Administration had granted De Novo authorization for its Queen of Hearts ACS AI ECG Model. The AI-powered technology was d...
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Jul 30, 2026
SIO Urges NCCN to Add Cryoablation to Breast Cancer Guidelines Following ProSense® FDA Clearance; NIPRO CORPORATION Secures FDA 510(k) Clearance for ELISIO™-HX HDs in the US; Akido Unveils the First AI-Native Health System in the U.S.; MemorialCare Enhances Diagnostic Imaging with Hung Family-Funded 3T MRI Technology; Aqua Medical Treats First U.S. Type 2 Diabetes Patient at UNC Health with Investigational Endoscopic Therapy; NeoCast Delivers Robust Hematoma Resolution and Functional Recovery in Final EMBO-02 First-in-Human Results
ceCure: SIO Petitions NCCN to Include Cryoablation in Breast Cancer Treatment Guidelines, Citing IceCure's FDA Clearance of ProSense® On 29 July 2026, the Society of Interventional Oncology (SIO) submitted a formal petition to the National Comprehensive Cancer Network (NCCN) seeking the inclusion of percut...
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Jun 17, 2026
Mapping the Mind: How Neurodiagnostics Is Redefining the Future of Brain Healthcare
The human brain, only three pounds of tissue, remains one of medicine's greatest frontiers. As neurological disorders emerge as the world's leading cause of disability, the tools we use to diagnose, monitor, and understand brain health have never been more consequential. Neurodiagnostics, encompassing the ful...
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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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Feb 05, 2026
GE HealthCare Secures FDA 510(k) Clearance and CE Mark for Allia Moveo, Completing First Global Installation; China NMPA Approves Promega’s MSI Test as a Companion Diagnostic for KEYTRUDA; Oracle Life Sciences AI Data Platform Unifies Data and Agentic Intelligence to Accelerate Breakthroughs and Boost Commercial Outcomes; Quest Diagnostics Launches New Blood Test for Detecting Minimal Residual Myeloma; RevBio Secures FDA Clearance to Begin Pivotal Study of Cranial Bone Glue; Hyperfine Reports Breakthrough Clinical Findings on Swoop® System’s Increased Sensitivity in Stroke Detection
GE HealthCare Announced the U.S. FDA 510(k) Clearance and CE Mark for Allia Moveo and marks first Global Installation, Advancing Precision Care in the Interventional Suite On February 02, 2026, GE HealthCare announced that Allia™ Moveo received U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Mark...
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Jan 22, 2026
Sonomotion Secures FDA Clearance for Break Wave™ Lithotripsy System; Aidoc Earns FDA Clearance for Comprehensive AI Foundation Model in Healthcare; BD and Ypsomed Deepen Partnership to Serve Expanding Biologics Market; Omnia Medical Launches FDA-Approved PsiF DNA™ System to Market; Kardium Publishes PULSAR Pivotal Trial Findings in JACC; NEURO PMR Data Validates Hyperfine’s Diagnostic Precision and Patient-Centered Care
Sonomotion Announced FDA Clearance for its Break Wave™ Lithotripsy Device for Treatment of Kidney Stones On January 21, 2026, SonoMotion, a venture-backed medical device company focused on developing non-invasive solutions for kidney stone treatment, announced that it had received U.S. Food and Drug Admini...
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Nov 27, 2025
Bracco Receives FDA Clearance for Additional Clinical Use of Max 3™ Syringeless MR Injector; RapidAI Broadens Clinical AI Portfolio with Five Newly Granted FDA Clearances; Ceribell Secures FDA 510(k) Clearance for Clarity® Algorithm in Neonatal Care; BD Introduces Surgiphor™ Irrigation System Across Europe to Enhance Surgical Patient Protection; Neurophet and The Florey Announce Strengthened Collaboration to Advance Alzheimer’s Diagnostic Solutions; VSI® Performs First-Ever Robotic Minimally Invasive Bertolotti’s Resection; BioWave® Demonstrates Safe and Effective Home-Based and War Injury Pain Relief in Latest Clinical Data
FDA Approved Expanded Indication for Max 3™ Syringeless MR Injector from Bracco On November 25, 2025, Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., announced that the U.S. Food and Drug Administration (FDA) expanded the indication for its Max 3™ Rapid Exchange and Syringeless Injector fo...
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May 15, 2025
Glucotrack Secures Ethical Approval for Extended Clinical Trial of Continuous Blood Glucose Monitor; GE HealthCare Announces FDA Approval for Pediatric Use of Optison and Launches New Ultra-premium 1.5T MRI System; Envoy Medical Advances to Final Stage Following Clinical Milestone; SeaStar Medical Hits Interim Enrollment Goal in NEUTRALIZE-AKI Trial; BD Unveils New Cell Analyzer Integrating Spectral and Real-Time Imaging Innovations
Glucotrack Announced Ethical Approval for Long-Term Clinical Study of Continuous Blood Glucose Monitor On May 13, 2025, Glucotrack, Inc., a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, announced that it received ethical app...
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Dec 05, 2024
FDA Approves Zimmer Biomet’s Oxford® Cementless Partial Knee; ReCerf® Sets Milestone as First All-Ceramic Hip Resurfacing Approved Worldwide; Orthocell Achieves US FDA 510(k) Clearance Milestone for Remplir Regulatory Study; Hologic’s Research Shows AI Breast Imaging Maintains Performance Across All Demographics; GE HealthCare Expands MRI Capabilities with Sonic DL’s Advanced Deep Learning; Terumo Unveils the R2P NaviCross Peripheral Support Catheter
Zimmer Biomet Received FDA Approval for Oxford® Cementless Partial Knee, the Only Cementless Partial Knee Replacement Implant in the U.S. On November 25, 2024, Zimmer Biomet Holdings, Inc., a global leader in medical technology, announced that its Oxford® Cementless Partial Knee received Premarket Approval...
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Nov 21, 2024
Cartessa Aesthetics teams with Classys for Everesse; LogicMark unveils Freedom Alert Max; GE HealthCare clears SIGNA MAGNUS MRI; OMRON’s BP monitor with AI-powered AFib detection gets FDA approval; Boston Scientific’s WATCHMAN FLX™ cuts bleeding risk; Encora Therapeutics wraps ULTRE trial for tremor device
Cartessa Aesthetics Partnered With Classys, Inc. to Bring Everesse to the US Market On November 14, 2024, Cartessa Aesthetics, a leading North American aesthetic medical device company, collaborated with Classys, Inc., a prominent global aesthetics firm based in South Korea, to introduce EVERESSE by Volnew...
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