510(k) https://www.bioworld.com/rss en-us FDA warns makers of HIV tests about test collection kits http://www.bioworld.com/articles/728252 Tue, 27 Jan 2026 11:00:00 -0500 https://www.bioworld.com/articles/728252-fda-warns-makers-of-hiv-tests-about-test-collection-kits FDA headquarters signage Credit: Tada Images - stock.adobe.com Naox secures FDA clearance for EEG earbuds http://www.bioworld.com/articles/727574 Tue, 06 Jan 2026 11:00:00 -0500 https://www.bioworld.com/articles/727574-naox-secures-fda-clearance-for-eeg-earbuds Naox Link Naox Link. Credit: Naox Technologies SaS Crescom wins FDA clearance for bone analysis http://www.bioworld.com/articles/727223 Wed, 24 Dec 2025 11:00:00 -0500 https://www.bioworld.com/articles/727223-crescom-wins-fda-clearance-for-bone-analysis Crescom MediAI-BA Crescom MediAI-BA bone age analysis software. Credit: Crescom Proverum, Zenflow secure FDA nod for systems to treat BPH http://www.bioworld.com/articles/727064 Mon, 15 Dec 2025 11:00:00 -0500 https://www.bioworld.com/articles/727064-proverum-zenflow-secure-fda-nod-for-systems-to-treat-bph Illustration of human anatomy, enlarged prostate Flow Neuro wins FDA nod for at-home device for depression http://www.bioworld.com/articles/726753 Thu, 11 Dec 2025 11:00:00 -0500 https://www.bioworld.com/articles/726753-flow-neuro-wins-fda-nod-for-at-home-device-for-depression Flow FL 100 on patient The Flow FL-100 uses transcranial direct current stimulation (tDCS) to treat depression. Credit: Flow Neuro Heartbeam wins appeal, gains FDA clearance http://www.bioworld.com/articles/726743 Wed, 10 Dec 2025 11:00:00 -0500 https://www.bioworld.com/articles/726743-heartbeam-wins-appeal-gains-fda-clearance Heartbeam Heartbeam Inc.’s on-the-go ECG device. Credit: Heartbeam FDA clears Dexcom Smart Basal for insulin optimization http://www.bioworld.com/articles/726211 Wed, 19 Nov 2025 11:00:00 -0500 https://www.bioworld.com/articles/726211-fda-clears-dexcom-smart-basal-for-insulin-optimization Dexcom G7 CGM Dexcom Inc.’s G7 continuous glucose monitor. FDA clears Withings Beamo, ‘thermometer of the future’ http://www.bioworld.com/articles/725992 Fri, 14 Nov 2025 11:00:00 -0500 https://www.bioworld.com/articles/725992-fda-clears-withings-beamo-thermometer-of-the-future Withings Beamo multi-sensor device Withings Beamo multi-sensor device. Credit: Withings France SA Magstim gets FDA nod for chronic pain treatment holland.johnson@clarivate.com http://www.bioworld.com/articles/725970 Wed, 12 Nov 2025 11:00:00 -0500 https://www.bioworld.com/articles/725970-magstim-gets-fda-nod-for-chronic-pain-treatment Magstim Magstim Rapid magnetic stimulation system. Credit: Magstim Co. Ltd. Tulyp emerges from stealth with pressure-driven perfusion system http://www.bioworld.com/articles/725512 Tue, 04 Nov 2025 11:00:00 -0500 https://www.bioworld.com/articles/725512-tulyp-emerges-from-stealth-with-pressure-driven-perfusion-system Blue heart and data grid FDA approves Medtronic Evolut for expanded redo TAVR indication http://www.bioworld.com/articles/723451 Thu, 28 Aug 2025 12:00:00 -0400 https://www.bioworld.com/articles/723451-fda-approves-medtronic-evolut-for-expanded-redo-tavr-indication Evolut device image Evolut Pro+ TAVR device. Credit: Medtronic plc FDA clears Artrya’s Salix AI coronary plaque module http://www.bioworld.com/articles/723205 Fri, 22 Aug 2025 12:00:00 -0400 https://www.bioworld.com/articles/723205-fda-clears-artryas-salix-ai-coronary-plaque-module Artryas Salix Artrya Ltd. Salix coronary anatomy software analyzes coronary computed tomography angiogram scans via AI to diagnose coronary artery disease. Credit: Artrya. Neuroone's Onerf wins FDA clearance for trigeminal nerve ablation http://www.bioworld.com/articles/723167 Mon, 18 Aug 2025 12:00:00 -0400 https://www.bioworld.com/articles/723167-neuroones-onerf-wins-fda-clearance-for-trigeminal-nerve-ablation Trigeminal Nerve Diagram of the trigeminal nerve. Credit: BruceBlaus, CC Industry sees need for clarity in FDA draft guidance for 510(k) transfers http://www.bioworld.com/articles/722820 Mon, 11 Aug 2025 12:00:00 -0400 https://www.bioworld.com/articles/722820-industry-sees-need-for-clarity-in-fda-draft-guidance-for-510k-transfers U.S. FDA headquarters Olympus co-launches Swan as new JV for endoluminal GI robotics http://www.bioworld.com/articles/722652 Tue, 05 Aug 2025 12:00:00 -0400 https://www.bioworld.com/articles/722652-olympus-co-launches-swan-as-new-jv-for-endoluminal-gi-robotics Hands holding arrow-shaped puzzle pieces Caranx Medical gets FDA nod for TAVR software Tavipilot Soft http://www.bioworld.com/articles/721963 Wed, 16 Jul 2025 12:00:00 -0400 https://www.bioworld.com/articles/721963-caranx-medical-gets-fda-nod-for-tavr-software-tavipilot-soft Tavipilot software Tavipilot software Synchrony receives FDA OK for Libairty airway clearance system http://www.bioworld.com/articles/721953 Tue, 15 Jul 2025 12:00:00 -0400 https://www.bioworld.com/articles/721953-synchrony-receives-fda-ok-for-libairty-airway-clearance-system Synchrony’s Libairty airway clearance system Synchrony’s Libairty airway clearance system FDA greenlights Boston Sci’s Farapulse for persistent AF http://www.bioworld.com/articles/721788 Mon, 07 Jul 2025 12:00:00 -0400 https://www.bioworld.com/articles/721788-fda-greenlights-boston-scis-farapulse-for-persistent-af Farawave system Boston Scientific’s Farapulse system with Farawave Nav ablation catheter Credit: Boston Scientific Corp. Rising demand spurs Neurent to open new Neuromark facility http://www.bioworld.com/articles/721132 Wed, 18 Jun 2025 12:00:00 -0400 https://www.bioworld.com/articles/721132-rising-demand-spurs-neurent-to-open-new-neuromark-facility Neuromark system Neuromark system. Credit: Neurent Medical Ltd. FDA clears Dexcom G7 15 Day http://www.bioworld.com/articles/718915 Fri, 11 Apr 2025 12:00:00 -0400 https://www.bioworld.com/articles/718915-fda-clears-dexcom-g7-15-day Dexcom G7 CGM Dexcom Inc.’s G7 continuous glucose monitor. Cardiovia Viaone epicardial access system secures US FDA clearance http://www.bioworld.com/articles/718914 Fri, 11 Apr 2025 12:00:00 -0400 https://www.bioworld.com/articles/718914-cardiovia-viaone-epicardial-access-system-secures-us-fda-clearance David Luria Ziv Menshes Prof. David Luria (left), Director of Electrophysiology at Hadassah Medical Center, and Ziv Menshes, CEO of Cardiovia. Credit: Cardiovia AI-enhanced mammogram readings are better, but ignored http://www.bioworld.com/articles/718902 Thu, 10 Apr 2025 12:00:00 -0400 https://www.bioworld.com/articles/718902-ai-enhanced-mammogram-readings-are-better-but-ignored Lunit Insight MMG Lunit Insight MMG. Credit: Lunit FDA gives nod to Orthocell’s 510(k) for nerve repair product http://www.bioworld.com/articles/718894 Wed, 09 Apr 2025 12:00:00 -0400 https://www.bioworld.com/articles/718894-fda-gives-nod-to-orthocells-510k-for-nerve-repair-product Orthocell Remplir Orthocell Ltd.’s regenerative nerve repair product, Remplir. Credit: Orthocell FDA clears Gleamer, Azmed AI-powered tools for chest X-rays http://www.bioworld.com/articles/718634 Tue, 01 Apr 2025 12:00:00 -0400 https://www.bioworld.com/articles/718634-fda-clears-gleamer-azmed-ai-powered-tools-for-chest-x-rays Illustration of lung cancer, DNA double helix ​US FDA clears Roche’s preeclampsia test http://www.bioworld.com/articles/716938 Fri, 14 Feb 2025 11:00:00 -0500 https://www.bioworld.com/articles/716938-us-fda-clears-roches-preeclampsia-test Roche building Credit: F. Hoffmann-La Roche Ltd. Essilorluxottica receives US, EU, green light for OTC Audio Glasses http://www.bioworld.com/articles/716792 Mon, 03 Feb 2025 11:00:00 -0500 https://www.bioworld.com/articles/716792-essilorluxottica-receives-us-eu-green-light-for-otc-audio-glasses Hand cupping ear to illustration hearing loss Inflammatix’s Triverity scores FDA clearance for ER sepsis test http://www.bioworld.com/articles/716154 Tue, 21 Jan 2025 11:00:00 -0500 https://www.bioworld.com/articles/716154-inflammatixs-triverity-scores-fda-clearance-for-er-sepsis-test Inflammatix Triverity test system Inflammatix Inc.’s Triverity test for sepsis runs on the Myrna instrument. Neurophet wins FDA nod for brain AI software, targets US expansion http://www.bioworld.com/articles/714490 Mon, 25 Nov 2024 11:00:00 -0500 https://www.bioworld.com/articles/714490-neurophet-wins-fda-nod-for-brain-ai-software-targets-us-expansion Neurophet Aqua Neurophet Aqua Brightheart secures FDA clearance for software to detect fetal heart defects http://www.bioworld.com/articles/714287 Thu, 21 Nov 2024 11:00:00 -0500 https://www.bioworld.com/articles/714287-brightheart-secures-fda-clearance-for-software-to-detect-fetal-heart-defects BrightHeart software BrightHeart software in use. Credit: Brightheart Smartcardia’s ECG patch gains FDA nod for outpatient cardiac telemetry http://www.bioworld.com/articles/714257 Mon, 18 Nov 2024 11:00:00 -0500 https://www.bioworld.com/articles/714257-smartcardias-ecg-patch-gains-fda-nod-for-outpatient-cardiac-telemetry Heart, DNA and ECG