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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.drugdeliverybusiness.com/minimed-fda-clearance-flex-insulin-pump/ MiniMed wins FDA clearance for next-gen Flex insulin pump Mar 18, 2026 - MiniMed (Nasdaq:MMED) announced today that it received FDA clearance for the MiniMed Flex next-generation insulin pump. wins fda next gen insulin pump minimed clearance https://markets.financialcontent.com/stocks/article/marketminute-2026-4-6-stereotaxis-secures-fda-clearance-for-synchrony-system-completing-its-vision-for-the-robotic-digital-cockpit FinancialContent - Stereotaxis Secures FDA Clearance for Synchrony™ System, Completing Its Vision... Apr 6, 2026 - Stereotaxis Secures FDA Clearance for Synchrony™ System, Completing Its Vision for the Robotic secures fda clearance financialcontent stereotaxis system completing https://www.biospace.com/press-releases/stereotaxis-announces-fda-clearance-and-launch-of-synchrony-system Stereotaxis Announces FDA Clearance and Launch of Synchrony System - BioSpace announces fda clearance stereotaxis launch synchrony system 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://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://www.medtechdive.com/news/philips-secures-fda-clearance-for-ai-enabled-ct-system/817786/ Philips secures FDA clearance for AI-enabled CT system | MedTech Dive The company aims to increase its share of the premium CT device market through 2028. secures fda clearance system medtech dive ai enabled philips ct https://www.femtechworld.co.uk/news/ark-surgical-secures-fda-clearance-for-lapbox-power-ark25/ Ark Surgical secures FDA clearance for LapBox POWER - FemTech World May 6, 2025 - Ark Surgical, a women’s health-focused medical device company, has received FDA 510(k) clearance for LapBox POWER, a breakthrough tissue containment system... secures fda clearance femtech world ark surgical power 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.prnewswire.com/news-releases/cala-announces-fda-clearance-of-its-next-generation-taps-therapy-wearable-device-for-essential-tremor-and-parkinsons-disease-302742780.html Cala Announces FDA Clearance of its Next Generation TAPS Therapy Wearable Device for Essential... Apr 15, 2026 - /PRNewswire/ -- Cala®, the bioelectronic medicine leader, today announced U.S. Food and Drug Administration (FDA) clearance of the Cala kIQ® Plus system, the... announces fda clearance next generation wearable device cala taps 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://bluegoatcyber.com/contact/ Blue Goat Cyber - Medical Device Cybersecurity for FDA Clearance medical device cybersecurity fda clearance blue goat https://www.medtechdive.com/news/akura-medical-35m-510k-thrombectomy/695609/ Akura Medical secures $35M to pursue FDA clearance for thrombectomy device | MedTech Dive The money also will help fund clinical trials for additional indications and the expansion of its manufacturing capabilities. device medtech dive fda clearance akura medical secures https://www.biospace.com/press-releases/the-university-of-colorado-anschutz-gates-institute-achieves-first-in-u-s-fda-clearance-for-campus-built-car-t-cell-therapy The University of Colorado Anschutz Gates Institute Achieves First-in-U.S. FDA Clearance for... colorado anschutz institute achieves fda clearance university gates https://www.asp.com/en-us/media/Advanced-Sterilization-Products-Announces-FDA-Clearance-Revolutionary-Sterilization-Cycle-Duodenoscopes Advanced Sterilization Products Announces FDA Clearance for Revolutionary Sterilization Cycle for... announces fda clearance advanced sterilization products revolutionary cycle https://kiierr.com/fda-clearance/ FDA Clearance - Kiierr Laser Hair Growth Cap That Grows Hair Kiierr's hair growth caps are proven to be the most effective FDA-cleared hair growth devices in the world! Start growing hair now! kiierr laser hair fda clearance growth cap grows https://www.medtechdive.com/news/dermasensor-fda-clearance-ai-skin-cancer-detection-device/704857/ Dermasensor wins FDA clearance for AI-enabled skin cancer detection device | MedTech Dive Jan 22, 2024 - A study found the sensitivity of the device was 96%, compared with 83% for primary care physicians. skin cancer detection device medtech dive wins fda ai enabled clearance https://9to5mac.com/2026/04/07/studio-display-xdr-medical-imaging-feature-fda-clearance/ Studio Display XDR medical imaging feature gets FDA clearance [U: Now available] - 9to5Mac Apr 7, 2026 - Apple's Medical Imaging Calibrator for Studio Display XDR received FDA clearance and will launch this week for radiology use. studio display xdr medical imaging feature gets fda clearance available 9to5mac 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://www.usa.philips.com/a-w/about/news/archive/standard/news/press/2026/fda-clears-philips-ai-solution-that-provides-real-time-guidance-during-complex-minimally-invasive-heart-valve-repair.html Philips DeviceGuide gets FDA Clearance | Philips Mar 26, 2026 - FDA clears Philips AI solution that provides real-time guidance during complex minimally invasive heart valve repair. gets fda philips clearance 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://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.macworld.com/article/3107146/apples-studio-display-xdr-gets-medical-imaging-clearance-from-the-fda.html Apple's Studio Display XDR gets medical imaging clearance from the FDA | Macworld Apr 6, 2026 - The feature will be available to users this week. studio display xdr gets medical apple imaging clearance https://www.prnewswire.co.uk/news-releases/bridge-to-life-secures-fda-de-novo-clearance-for-vitasmart-hypothermic-oxygenated-perfusion-hope-system-the-first-ever-us-approval-for-cold-machine-perfusion-in-liver-transplant-preservation-302665915.html Bridge to Life™ Secures FDA De Novo Clearance for VitaSmart™ Hypothermic Oxygenated Perfusion... Jan 20, 2026 - /PRNewswire/ -- Bridge to Life™ Ltd., a global innovator in organ preservation and perfusion technologies, today announced that the U.S. Food and Drug... secures fda de novo bridge clearance oxygenated https://www.prweb.com/releases/theodent-secures-fda-510k-clearance-for-rennou-varnish-the-first-professional-fluoride-free-cavity-varnish-authorized-in-the-us-302480847.html Theodent secures FDA 510(k) clearance for Rennou® Varnish, the first professional fluoride-free... fda 510 k first professional fluoride free secures clearance https://www.hairfacts.com/tips/govregs/fda-510k-clearance-tweezer-type-epilators/ FDA 510(k) clearance: Tweezer-type epilators – HairFacts | Hair Removal Information FDA 510(k) clearances: Electric tweezers Beginning on 28 May 1976, the US Food and Drug Administration (FDA) began requiring new medical devices to demonstrate... fda 510 k hairfacts hair removal clearance tweezer type 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