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Surgical Theater’s SyncAR Spine Platform Secures the US FDA’s 510(k) Clearance for Spine Surgery

Shots:The US FDA has granted 510(k) clearance to SyncAR Spine platform to enhance precision in spine surgerySyncAR Spine, integrated with Medtronic StealthStation, uses AI-driven vertebra segmentation, advanced decompression planning, & segmental fusion to streamline surgical planning & help align preoperative models with intraoperative CTSyncAR Spine also allows surgeons to monitor bone removal…
October 13, 2025

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Bunkerhill Health Receives the US FDA’s 510(k) Clearance for Bunkerhill MAC to Detect and Quantify Mitral Annular Calcification

Shots:The US FDA has granted 510(k) clearance to Bunkerhill MAC algorithm for the detection & quantification of mitral annular calcification (MAC)Bunkerhill MAC, developed & tested using data from 25+ academic centers incl. Emory, Thomas Jefferson, & UCSF, automatically identify & quantify MAC on routine non-gated chest CTs using AI to standardize MAC detection &…
October 9, 2025

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Hologic Secures the US FDA’s 510(k) Clearance & European CE Mark for Panther Fusion GI Bacterial Assays to Advance Gastroenteritis Diagnostics

Shots:Hologic has received the US FDA’s 510(k) clearance & European IVDR CE Mark approval for its Panther Fusion Gastrointestinal (GI) Bacterial & Expanded Bacterial AssaysPanther Fusion GI assays quickly detect key bacterial pathogens causing infectious gastroenteritis, incl. Salmonella, E. coli (incl.O157), Campylobacter, Shigella, Vibrio, Yersinia, & Plesiomonas, using customizable molecular mini-panels to allow…
October 3, 2025

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Amber implants
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Amber Implants Reports the US FDA’s 510(k) Clearance of VCFix Spinal System for Treating Vertebral Compression Fractures

Shots:The US FDA has granted 510(k) clearance to VCFix Spinal System for thetreatment of vertebral compression fracturesThe company plans to launch a US pilot program in early 2026, expand physician access later that year, extend the EXPAND trial into the US, & pursue EU label expansion for stand-alone use & one-level fixation integration…
September 17, 2025

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Tempus AI Receives the US FDA’s 510(k) Clearance for Updated Tempus Pixel Cardiac Imaging Platform

Shots:Tempus AI has received the US FDA 510(k) clearance for its updated Tempus Pixel, an AI-powered cardiac imaging platform, with the ability to generate T1 & T2 inline maps for enhanced cardiac MRI analysisTempus Pixel delivers advanced viewing & automated reporting of cardiac MR images, improving efficiency and accuracy in flow visualization, functional…
September 12, 2025

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Roche
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Roche Receives the US FDA’s 510(k) Clearance for cobas Respiratory 4-flex for Comprehensive Respiratory Pathogen Detection

Shots:The US FDA has granted 510(k) clearance to cobas Respiratory 4-flex, which utilizes TAGS technology for simplification of respiratory testing & improving diagnostic speed as well as accuracyThe cobas Respiratory 4-flex integrates seamlessly with cobas 5800, 6800 & 8800 systems to allow qualitative detection & differentiation of SARS-CoV-2, influenza A/B, as well as…
August 7, 2025

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NEWS

Cardiosense’s CardioTag Device Receives the US FDA’s 510(k) Clearance for Cardiac Function Assessment

Shots:The US FDA has granted 510(k) clearance to CardioTag device for assessing cardiac function Upon regulatory approval for the PCWP Analysis Software, the algorithm will be integrated with the CardioTag device for advanced heart failure management, following a multicenter study showing its PCWP value estimates matched implantable hemodynamic sensor accuracy in HFrEF pts; data was published…
July 31, 2025

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