https://www.businesswire.com/news/home/20240103951055/en/Nanowear-Announces-FDA-510k-Clearance-for-AI-enabled-Continuous-Blood-Pressure-Monitoring-and-Hypertension-Diagnostic-Management-SimpleSense-BP
Nanowear, a leader in healthcare-at-home remote diagnostics, announced that its nanotechnology-enabled wearable and software platform, SimpleSenseTM, has rec...
announcesfdakclearanceai
https://www.pharmaceutical-technology.com/contractors/drug-delivery/ypsomed/pressreleases/ypsomed-receives-fda-clearance-smartpilot/
The US Food and Drug Administration (FDA) has granted 510(k) clearance for SmartPilot, a digital connectivity add-on developed by Ypsomed.
fda clearancepharmaceutical technologyypsomedreceives
https://www.prnewswire.com/news-releases/proprios-fourth-fda-clearance-highlights-growing-shift-to-3d-measurement-in-spine-care-302662601.html
/PRNewswire/ -- Proprio, the surgical technology company pioneering real-time, AI-powered intraoperative guidance and data-driven surgical workflows, today...
fda clearancepropriofourthhighlightsgrowing
https://www.globenewswire.com/news-release/2023/05/01/2658318/0/en/Nanox-ARC-Imaging-System-Receives-FDA-Clearance-Pioneering-a-New-Era-in-Medical-Imaging.html
Nanox.ARC presents high powered digital X-ray tubes for 3D tomosynthesis imagingNanox.ARC could help expand the availability of medical imaging NEVE...
imaging systemfda clearancearcreceivespioneering
https://www.prnewswire.com/news-releases/aqualung-therapeutics-receives-fda-clearance-for-phase-2a-lung-fibrosis-study-302648010.html
/PRNewswire/ -- Aqualung Therapeutics, a clinical-stage immunotherapeutics company, announced today that the Food and Drug Administration (FDA) has cleared...
fda clearancelung fibrosisaqualungtherapeuticsreceives
https://www.biospace.com/aquavit-receives-fda-clearance-for-two-inds-to-initiate-clinical-trials-with-its-botulinum-toxin
Aquavit Holdings announced that it has received FDA clearance to initiate clinical trials for DTX-023 and DTX-024, following its submission of Investigational...
fda clearanceaquavitreceivestwoinds
https://www.prnewswire.com/news-releases/trace-biosciences-announces-fda-ind-clearance-for-first-nerve-specific-imaging-agent-302675689.html
/PRNewswire/ -- Trace Biosciences, Inc., a clinical-stage biotechnology company developing nerve-targeted imaging agents, today announced that the U.S. Food...
tracebiosciencesannouncesfdaind
https://www.biospace.com/genfit-announces-fda-protocol-clearance-for-phase-2-clinical-trial-of-elafibranor-in-pediatric-nash
FDA accepts study protocol, providing green light for GENFIT to initiate Phase 2 clinical trial in pediatric NASH
clinical trialannouncesfdaprotocolclearance
https://www.prnewswire.com/news-releases/mosie-baby-becomes-the-first-company-to-receive-fda-clearance-for-at-home-intravaginal-insemination-302003665.html
/PRNewswire/ -- Mosie Baby, a pioneering at-home fertility care company, has secured FDA Class II clearance for its Mosie Baby Kit making it the first and...
fda clearancebabybecomesfirstcompany
https://www.globenewswire.com/news-release/2025/05/28/3089530/0/en/Distalmotion-Gains-FDA-510-k-Clearance-for-Cholecystectomy-Further-Advancing-Access-to-Robotics-in-the-Outpatient-Setting-with-its-DEXTER-Robotic-Surgery-System.html
Lausanne, Switzerland, May 28, 2025 (GLOBE NEWSWIRE) -- Distalmotion, the global MedTech company empowering access to the benefits of robotic surgery in...
distalmotiongainsfdakclearance
https://www.finanznachrichten.de/nachrichten-2026-02/67628017-reportable-inc-medcognetics-receives-fda-510-k-clearance-for-cognet-ai-mt-radiological-computer-aided-triage-and-notification-software-296.htm
Dallas, Texas--(Newsfile Corp. - February 5, 2026) - MedCognetics, Inc., a company focusing on medical imaging AI, today announced it has received U.S. Food...
increceivesfdakclearance
https://www.prnewswire.com/news-releases/abbotts-amplatzer-piccolo-delivery-system-receives-fda-clearance-and-ce-mark-to-optimize-procedures-for-premature-babies-with-a-hole-in-the-heart-302645632.html
/PRNewswire/ -- Abbott (NYSE: ABT) today announced it has received U.S. Food and Drug Administration (FDA) clearance and CE Mark for its Amplatzer Piccolo™...
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https://www.fox5dc.com/video/1729311
FOX 5 talked to a teen five years ago about a diabetes app in production. Now, the app has received FDA clearance.
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https://www.biospace.com/horiba-medical-receives-fda-clearance-and-health-canada-clearance-for-the-yumizen-c1200-clinical-chemistry-system-designed-to-help-labs-deliver-faster-results-to-clinicians-and-patients
HORIBA Medical, a leading global diagnostic company providing solutions in chemistry, hematology and hemostasis, today announced that it has obtained U.S. Food...
horiba medicalfda clearancehealth canadareceives
https://www.prnewswire.com/news-releases/ventana-receives-fda-clearance-for-estrogen-receptor-er-image-analysis-and-digital-read-application-for-breast-cancer-234579611.html
/PRNewswire/ -- Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, received 510(k) clearance from the U.S. Food and Drug Administration...
fda clearanceestrogen receptorimage analysisventanareceives
https://www.news-medical.net/news/20110613/Siemens-receives-FDA-clearance-for-Biograph-mMR-system-to-perform-simultaneous-PETMRI-scan.aspx
The U.S. Food and Drug Administration today cleared the Siemens Biograph mMR system, the first device to simultaneously perform a positron emission tomography...
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https://vir.com.vn/d3-bio-gains-fda-clearance-for-two-trials-144964.html
The biotechnology company secured regulatory approval to advance two investigational drug studies, including a phase one trial and a combination therapy study,...
fda clearancebiogainstwotrials
https://www.biospace.com/lexeo-therapeutics-announces-fda-clearance-of-ind-for-lx2020-an-aav-based-gene-therapy-candidate-for-pkp2-arrhythmogenic-cardiomyopathy
LEXEO Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for LX2020....
fda clearancetherapeuticsannouncesind
https://www.pathai.com/aisightdx-digital-pathology-solution
Sep 9, 2025 - PathAI has received 510(k) clearance from the FDA for AISight® Dx—PathAI’s digital pathology image management system for use in primary diagnosis in...
fda clearancedxreceivesuseprimary
https://www.prnewswire.com/news-releases/obi-pharma-announces-us-fda-clearance-of-ind-application-for-a-phase-12-study-of-its-antibody-drug-conjugate-adc-targeted-cancer-therapy-obi-999-300910121.html
/PRNewswire/ -- OBI Pharma, a Taiwan biopharma company (TPEx: 4174), today announced that the U.S. Food and Drug Administration (FDA) has cleared an...
fda clearanceobipharmaannouncesind
https://www.prnewswire.com/news-releases/stimlabs-announces-fda-clearance-of-theracor-the-first-human-umbilical-cord-derived-medical-device-sheet-302649759.html
/PRNewswire/ -- StimLabs announces that the U.S. Food & Drug Administration (FDA) has granted 510(k) clearance for Theracor, the first human umbilical...
fda clearancefirst humanannouncesumbilical
https://technical.ly/startups/baltimore-based-sonavex-receives-fda-clearance-for-ultrasound-implant-devices/
Echomark will be the first product marketed by the Johns Hopkins spinout. Sonavex CEO David Narrow said more products are in the pipeline.
fda clearancemedical imagingbaltimorebasedreceives
https://www.news-medical.net/news/20131002/Esteya-system-for-high-precision-skin-cancer-treatment-gets-FDA-clearance.aspx
Esteya, an electronic brachytherapy system, has received 510(k) clearance from the U.S. Food and Drug Administration, enabling medical centers in the United...
skin cancer treatmenthigh precisionesteyasystemgets
https://www.businesswire.com/news/home/20210312005084/en/Baxter-Announces-U.S.-FDA-510k-Clearance-of-AK-98-Hemodialysis-Machine
Baxter International Inc. (NYSE:BAX), a global innovator in renal care, today announced U.S. Food and Drug Administration (FDA) clearance of its next-generat...
baxterannouncesfdakclearance
https://info.pathai.com/pathai-receives-fda-clearance-for-aisight-dx
Sep 9, 2025 - PathAI has received 510(k) clearance from the FDA for AISight® Dx—PathAI’s digital pathology image management system—for use in primary diagnosis in...
fda clearancedxreceivesuseprimary
https://www.foxbusiness.com/markets/pacira-pharma-skids-as-fda-refuses-to-grant-new-clearance-for-post-surgery-pain-drug-exparel
Shares of Pacira Pharmaceuticals tumbled Monday after the company said regulators refused to grant a new marketing approval for its post-surgical pain drug...
new clearancepacirapharmaskidsfda
https://www.prnewswire.com/news-releases/zynex-obtains-fda-clearance-for-new-pain-management-device-302236209.html
/PRNewswire/ -- Zynex Inc. (NASDAQ: ZYXI), a leading medical technology company specializing in non-invasive medical devices for pain management and...
fda clearancepain managementzynexobtainsnew
https://www.essilorluxottica.com/en/newsroom/press-releases/fda-clearance-and-eu-certifications-for-nuance-audio/?cid=ST-SOF_250203-NUANCE_FDA
EssilorLuxottica receives FDA clearance and EU certifications for Nuance Audio, making it available to consumers in the U.S. and Europe
fda clearancenuance audioessilorluxotticareceiveseu
https://investorplace.com/2022/08/brainsway-bway-stock-pops-10-on-fda-clearance-news/
BrainsWay's platform to treat mental health disorders might seem unusual to some observers, but BWAY stock traders are optimistic today.
fda clearancebrainswaybwaystockpops
https://www.biospace.com/calypso-medical-receives-fda-510-k-clearance-for-the-calypso-r-4d-localization-system
calypsomedicalreceivesfdak
https://www.biospace.com/nmd-pharma-receives-ind-clearance-from-the-fda-to-initiate-a-phase-2-clinical-trial-of-nmd670-in-charcot-marie-tooth-disease-in-the-us
NMD Pharma A/S, a clinical-stage biotech company dedicated to developing novel and improved treatments for patients living with severe neuromuscular diseases,...
nmdpharmareceivesindclearance
https://www.prnewswire.com/news-releases/luminex-corporation-receives-fda-and-european-clearance-for-a-new-personalized-medicine-genotyping-assay-xtag-cyp2c19-kit-224912632.html
/PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX) today announced it has received U.S. FDA and European clearance for a comprehensive genotyping assay,...
luminex corporationeuropean clearancereceivesfdanew
https://www.prnewswire.com/news-releases/sibel-health-announces-fda-clearance-for-anne-onea-flexible-wireless-vital-signs-monitoring-platform-301408901.html
/PRNewswire/ -- Sibel Health, an award-winning medical technology company spun out of the Querrey Simpson Institute for Bioelectronics at Northwestern...
fda clearancesibelhealthannouncesanne
https://www.biospace.com/heartflow-files-for-fda-clearance-of-next-generation-product-offering-to-help-evaluate-the-presence-of-narrowings-and-plaque-in-the-coronary-arteries
HeartFlow, Inc., the leader in revolutionizing precision heart care, announced it has submitted a 510k premarket application to the U.S. Food and Drug...
fda clearancenext generationproduct offeringfiles
https://www.notebookcheck.net/CardieX-CONNEQT-Pulse-heart-health-monitor-now-has-FDA-510-k-clearance.710329.0.html
The CardieX CONNEQT Pulse blood pressure monitor has received FDA 510(k) clearance. The gadget uses patented technology to provide more insights than a...
heart healthconneqtpulsemonitorfda
https://www.prnewswire.com/il/news-releases/chemomab-announces-fda-clearance-of-its-ind-application-for-cm-101-a-first-in-class-ccl24-neutralizing-antibody-for-the-treatment-of-primary-sclerosing-cholangitis-301435989.html
/PRNewswire/ -- Chemomab Therapeutics, Ltd. (Nasdaq: CMMB) (Chemomab), a clinical-stage biotech company focused on the discovery and development of...
fda clearanceannouncesindapplicationcm
https://www.philips.com/a-w/about/news/archive/standard/news/press/2022/20220315-latest-release-of-philips-capsule-surveillance-receives-fda-clearance.html
The latest Philips Capsule Surveillance solution has received 510(k) market clearance from the U.S. Food & Drug Administration (FDA), paving the way for...
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https://www.biospace.com/fda-clearance-granted-for-first-ai-powered-medical-device-to-detect-all-three-common-skin-cancers-melanoma-basal-cell-carcinoma-and-squamous-cell-carcinoma
FDA Clearance Granted for First AI-Powered Medical Device to Detect All Three Common Skin Cancers (Melanoma, Basal Cell Carcinoma and Squamous Cell Carcinoma).
fda clearanceai poweredmedical devicegrantedfirst
https://www.auganix.org/ar-news-sentiar-announces-second-fda-clearance-for-its-commandep-ar-medical-interface/
Oct 13, 2023 - SentiAR, a Magic Leap partner, has announced its second FDA 510K clearance for its CommandEP AR medical interface | AR News from Auganix.org
fda clearanceannouncessecondinterface
https://investorplace.com/2023/09/ttoo-stock-alert-t2-confirms-fda-clearance-for-biothreat-panel/
T2 Biosystems is plunging today despite receiving good news from the FDA yesterday. Here's what investors should know about TTOO stock.
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https://www.nsmedicaldevices.com/news/orthoxel-earns-fda-510k-clearance-for-vertex-hip-fracture-nail-hfn/
May 10, 2024 - Irish medical technology firm OrthoXel has received the US Food and Drug Administration clearance for the Vertex Hip Fracture Nail (HFN).
hip fractureearnsfdakclearance
https://www.fiercebiotech.com/medtech/fda-grants-medical-device-clearance-snoo-robotic-baby-bassinet
Already popular with the parents of newborns, the makers of the Snoo motorized bassinet hope it will become the favored choice among hospitals and, perhaps one...
baby bassinetmedical devicesnooroboticgranted
https://www.massdevice.com/depuy-synthes-lands-fda-clearance-for-velys-robotic-knee-system/
Jan 20, 2021 - Johnson & Johnson (NYSE:JNJ) unit DePuy Synthes announced that it received FDA 510(k) clearance for the Velys system.
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https://www.clinicaltrialsarena.com/news/lexaria-fda-hypertension-trial/
The US FDA has granted IND clearance for Lexaria Bioscience to commence the Phase Ib clinical trial of DehydraTECH-CBD to treat hypertension.
phase ibreceivedfdaindclearance
https://www.prnewswire.com/news-releases/body-vision-medical-receives-fda-clearance-for-the-lungvision-tool-part-of-the-lungvision-platform-revolutionizing-the-areas-of-lung-cancer-diagnostics-and-treatment-300638819.html?tc=eml_cleartime
/PRNewswire/ -- Body Vision Medical, a medical device company specializing in augmented real-time imaging, artificial intelligence and intra-body navigation,...
body visionfda clearancemedicalreceivestool