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https://orthospinenews.com/2026/03/31/restore-robotics-receives-fda-510k-clearance-for-two-additional-da-vinci-xi-robotic-instruments/ Restore Robotics Receives FDA 510(k) Clearance for Two Additional da Vinci Xi® Robotic Instruments... receives fda 510 k clearance two additional restore robotics https://diagnostics.roche.com/us/en/news-listing/2026/fda-cobas-c-703-cobas-ise-neo.html Roche receives FDA 510(k) clearance for bcobas/b® c 703 and bcobas/b® ISE neo,... receives fda 510 k clearance roche 703 ise https://www.philips.com/a-w/about/news/archive/standard/news/press/2026/philips-receives-fda-510k-clearance-for-verida-the-worlds-first-ai-powered-detector-based-spectral-ct-advancing-diagnostic-precision-across-clinical-applications.html Philips receives FDA clearance for Verida spectral CT | Philips Apr 16, 2026 - Philips receives FDA 510(k) clearance for Verida CT, bringing AI-powered spectral CT to the United States, advancing diagnostic precision. receives fda clearance philips spectral https://www.medtechdive.com/news/bd-fda-warning-letter-pyxis-safety/736124/ BD receives FDA warning letter over quality system violations | MedTech Dive Inspectors found 111 open tickets for software defects categorized as catastrophic or severe patient harm. Several safety complaints were also listed that BD... fda warning letter quality system medtech dive bd receives https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-pediatric-patients-aged-12-moderate-severe-hidradenitis-suppurativa Novartis Cosentyx® receives FDA approval for pediatric patients aged 12+ with moderate to severe... receives fda approval pediatric patients aged 12 novartis moderate https://www.healio.com/news/orthopedics/20240826/vericel-receives-fda-approval-for-arthroscopic-maci-delivery Vericel receives FDA approval for arthroscopic MACI delivery Aug 26, 2024 - Vericel has received FDA approval to expand its MACI label to include MACI Arthro, an arthroscopic delivery of MACI to repair symptomatic knee cartilage... receives fda approval vericel arthroscopic maci delivery https://www.prweb.com/releases/prana-surgical-announces-the-prana-system-receives-fda-clearance-302732224.html Prana Surgical Announces the Prana System™ Receives FDA Clearance Apr 2, 2026 - /PRNewswire-PRWeb/ -- Prana Surgical, a Houston-based medical device company, announced today that the U.S. Food and Drug Administration (FDA) has granted... receives fda clearance prana surgical announces https://loyal.com/posts/loy-002-rxe Loyal Receives FDA Acceptance of Reasonable Expectation of Effectiveness for Senior Dog Lifespan... Sep 16, 2021 - Pioneering canine longevity company is one step closer to delivering an FDA-approved drug that will help dogs live longer, healthier lives and closes $22M B-2... receives fda senior dog loyal acceptance reasonable https://www.voxelmatters.com/lincotek-receives-fda-clearance-for-sportlinc-syndesmosis-device/ Lincotek receives FDA clearance for SportLinc syndesmosis device | VoxelMatters - The heart of... Apr 20, 2026 - Device consists of an ultra-high-molecular-weight polyethylene (UHMWPE) suture tensioned between two low-profile titanium alloy buttons. receives fda clearance device voxelmatters heart https://anunciamedical.com/anuncia-medical-receives-fda-breakthrough-device-designation-for-reflow-external-ventricular-drains-evd/ Anuncia Medical Receives FDA Breakthrough Device Designation for ReFlow® External Ventricular... Oct 13, 2025 - Company Proudly Expands Cerebrospinal Fluid (CSF) Management and Critical Care Solutions Portfolio Along with Receiving Flinn Foundation Grant Company... receives fda breakthrough device anuncia medical designation https://www.npr.org/transcripts/nx-s1-5795526 A gene therapy for a rare form deafness receives FDA approval : NPR Apr 23, 2026 - The treatment, developed by Regeneron Pharmaceuticals, is for a very rare form of deafness. But it represents a medical milestone. receives fda approval gene therapy rare form deafness npr https://news.medtronic.com/2026-03-27-Medtronic-Receives-FDA-Clearance-for-Stealth-AXiS-TM-Surgical-System-for-Cranial-and-ENT-Procedures Medtronic Receives FDA Clearance for Stealth AXiS™ Surgical System for Cranial and ENT Procedures -... receives fda clearance surgical system medtronic stealth cranial https://www.femtechworld.co.uk/news/smart-baby-monitoring-device-receives-fda-clearance/ Smart baby monitoring device receives FDA clearance - FemTech World Jun 22, 2023 - The device provides a real-time display of the baby’s heart rate and oxygen saturation level receives fda clearance smart baby monitoring device femtech world https://www.prweb.com/releases/hope-in-fight-against-pediatric-cancers-allterum-therapeutics-receives-fda-clearance-of-investigational-new-drug-ind-appl-for-4a10-in-acute-lymphoblastic-leukemia-302580089.html Hope in Fight Against Pediatric Cancers: Allterum Therapeutics Receives FDA Clearance of... Oct 9, 2025 - Advancing Hope in the Fight Against Pediatric Cancers: Allterum Therapeutics Receives FDA Clearance of Investigational New Drug (IND) Application for 4A10 in... receives fda clearance pediatric cancers hope fight therapeutics https://abbott.mediaroom.com/2025-12-22-Abbotts-Volt-TM-Pulsed-Field-Ablation-System-Receives-FDA-Approval-to-Treat-Patients-with-Atrial-Fibrillation Abbott's Volt™ Pulsed Field Ablation System Receives FDA Approval to Treat Patients with Atrial... pulsed field ablation receives fda approval treat patients abbott system https://thalassaemia.org.cy/news/waiha-rilzabrutinib-receives-fda-breakthrough-therapy-designation/ wAIHA | Rilzabrutinib Receives FDA Breakthrough Therapy Designation – TIF Mar 9, 2026 - Warm autoimmune haemolytic anaemia is a rare autoimmune disorder characterized by the premature dest receives fda breakthrough therapy designation tif https://www.npr.org/2026/04/23/nx-s1-5795526/deafness-gene-therapy-regeneron A gene therapy for a rare form deafness receives FDA approval : NPR Apr 23, 2026 - The treatment, developed by Regeneron Pharmaceuticals, is for a very rare form of deafness. But it represents a medical milestone. receives fda approval gene therapy rare form deafness npr https://www.itnonline.com/content/abbott-receives-fda-clearance-ce-mark-next-gen%C2%A0ai-powered-coronary-imaging-platform Abbott Receives FDA Clearance, CE Mark for Next-Gen AI-powered Coronary Imaging Platform | Imaging... Ultreon 3.0 software integrates high-resolution coronary plaque images and AI-automated insights to guide physician stent sizing and placement to maximize... receives fda clearance next gen ai imaging platform abbott mark https://atdc.org/us-food-and-drug-administration-gives-huxley-medical-510k-clearance-for-sansa-home-sleep-apnea-test/ Huxley Medical Receives FDA 510(k) | ATDC Member Company Dec 2, 2025 - Huxley Medical earns FDA 510(k) clearance for SANSA, the first chest-worn AI-powered home sleep apnea diagnostic patch improving patient outcomes. receives fda 510 atdc member company huxley medical k https://abbott.mediaroom.com/2025-12-18-Abbotts-Amplatzer-Piccolo-TM-Delivery-System-Receives-FDA-Clearance-and-CE-Mark-to-Optimize-Procedures-for-Premature-Babies-With-a-Hole-in-the-Heart Abbott's Amplatzer Piccolo™ Delivery System Receives FDA Clearance and CE Mark to Optimize... receives fda clearance delivery system abbott mark optimize https://www.medtechdive.com/news/medline-recalls-angiographic-syringes-receives-fda-warning-letter/817433/ Medline recalls angiographic syringes, receives FDA warning letter | MedTech Dive The company removed the devices from the market in February following complaints of the syringes disconnecting from manifolds. fda warning letter medtech dive medline recalls syringes https://www.biospace.com/epitel-receives-fda-510-k-clearance-for-two-new-technologies-remi-remote-eeg-monitoring-system-for-ambulatory-use-and-remi-vigilenz-ai-for-event-detection Epitel Receives FDA 510(k) Clearance for Two New Technologies: REMI Remote EEG Monitoring System... Apr 24, 2024 - Epitel, a leader in AI technologies for patient-focused brain health solutions, announced today it received U.S. Food and Drug Administration (FDA) 510(k)... receives fda 510 k clearance two new monitoring system https://www.prweb.com/releases/spinepoint-receives-us-fda-510k-clearance-for-flex-z-cervical-cage-first-product-in-the-ultra-low-stiffness-cushioning-interbody-platform-302725995.html SpinePoint Receives U.S. FDA 510(k) Clearance for Flex-Z™ Cervical Cage/ First Product in the... Mar 27, 2026 - /PRNewswire-PRWeb/ -- SpinePoint LLC, a medical device company developing low stiffness cushioning spinal interbody cages through advanced additive... fda 510 k receives u cage first clearance flex