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https://www.nichd.nih.gov/news/releases/051517-rehabtech NIH-funded rehabilitation technologies receive FDA clearance | NICHD - Eunice Kennedy Shriver... Devices bolster function and ability for people with disabilities or injuries. rehabilitation technologies fda clearance nih funded receive https://alumni.utk.edu/medical-device-startup-founded-by-alumni-receives-fda-clearance/ Medical Device Startup Founded by Alumni Receives FDA Clearance | UT Knoxville Alumni Feb 22, 2024 - Two University of Tennessee, Knoxville, alumni took an idea for an innovative medical device and developed the product and pitch medical device fda clearance startup founded https://www.businesswire.com/news/home/20200824005644/en/Gyroscope-Therapeutics-Announces-FDA-Clearance-for-Orbit-Subretinal-Delivery-System Gyroscope Therapeutics Announces FDA Clearance for Orbit Subretinal Delivery System fda clearance gyroscope therapeutics announces orbit https://www.globenewswire.com/fr/news-release/2026/02/19/3241113/0/en/Dror-Ortho-Design-Receives-510-k-FDA-Clearance-for-Next-Generation-Smile-Correction-Solution.html Dror Ortho-Design Receives 510(k) FDA Clearance for FDA clearance paves the way for U.S. commercial launch of innovative alternative to traditional aligners... fda clearance dror ortho design receives https://mede.caltech.edu/news/caltech-startup-receives-fda-clearance-for-heart-health-diagnostic-1 Caltech Startup Receives FDA Clearance for Heart Health Diagnostic - Medical Engineering A health care startup founded by researchers from Caltech hopes to make heart failure diagnosis more straightforward and accessible, potentially changing the... fda clearance heart health caltech startup receives https://www.businesswire.com/news/home/20231004721332/en/Sanguina-Announces-U.S.-FDA-Clearance-for-AnemoCheck-Home Sanguina Announces U.S. FDA-Clearance for AnemoCheck Home Today, Sanguina, Inc. (Sanguina), a leading biotech company, is pleased to announce the FDA clearance of AnemoCheck Home, the only FDA-cleared home hemoglobi... u s fda clearance sanguina announces https://www.newswire.ca/news-releases/navident-evo-receives-fda-clearance-for-guided-endodontics-822673437.html Navident EVO receives FDA Clearance for Guided Endodontics /CNW/ - ClaroNav Inc, a leader in surgical navigation and photogrammetry systems, is proud to announce that it has received clearance from the U.S. Food and... fda clearance navident evo receives guided https://www.philips.com/a-w/about/news/archive/standard/news/articles/2025/philips-advances-mri-speed-and-precision-with-fda-510k-clearance-of-smartspeed-precise-dual-ai-software.html FDA clearance for Philips SmartSpeed Precise | Philips Philips has received FDA 510(k) clearance for its SmartSpeed Precise MR deep learning reconstruction software, the industry's first integrated dual AI solution. fda clearance for philips smartspeed precise https://www.businesswire.com/news/home/20250218290234/en/Hologic-Announces-FDA-Clearance-of-Aptima-SARS-CoV-2-Assay Hologic Announces FDA Clearance of Aptima SARS-CoV-2 Assay Hologic Announces FDA Clearance of Aptima SARS-CoV-2 Assay fda clearance sars cov hologic announces assay https://www.businesswire.com/news/home/20251118787982/en/RapidAI-Earns-FDA-Clearance-for-Rapid-Aortic-Bringing-AI-Driven-Aortic-Measurements-and-Surveillance-to-Care-Teams RapidAI Earns FDA Clearance for Rapid Aortic, Bringing AI-Driven Aortic Measurements and... RapidAI, the pioneer of deep clinical AI and global leader in enterprise imaging, today announced U.S. Food and Drug Administration (FDA) clearance of Aortic... fda clearance https://brandequity.economictimes.indiatimes.com/news/business-of-brands/essilorluxottica-receives-fda-clearance-for-its-nuance-audio-glasses/117881590 EssilorLuxottica receives FDA clearance for its Nuance audio glasses, ETBrandEquity EssilorLuxottica has received approval from the U.S. FDA for its innovative Nuance audio glasses, combining hearing solutions with prescription glasses. This... nuance audio glasses fda clearance essilorluxottica receives https://ducknetweb.blogspot.com/2007/11/toshiba-aquilionone-receives-fda.html Toshiba's AquilionONE Receives FDA Clearance - Medical Quack An organ can be scanned in one rotation...eliminating the need to reconstruct slices from multiple points in time...and everything is in 3D.... fda clearance toshiba receives medical quack 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 Philips receives FDA 510(k) clearance for Verida CT, bringing AI-powered spectral CT to the United States, advancing diagnostic precision. fda clearance philips receives spectral https://www.businesswire.com/news/home/20210818005547/en/EchoNous-Receives-FDA-Clearance-for-Lexsa-Linear-Probe-Designed-for-Kosmos-Ultraportable-Ultrasound-Platform EchoNous Receives FDA Clearance for Lexsa Linear Probe, Designed for Kosmos Ultraportable... EchoNous, the leader in portable AI-guided ultrasound tools and software, announced today that the U. S. Food and Drug Administration (FDA) has cleared Lexsa... fda clearance echonous receives https://www.prnewswire.com/news-releases/wontech-receives-fda-clearance-for-hairboom-air-300937678.html WONTECH Receives FDA Clearance for 'HairBoom Air' /PRNewswire/ -- WONTECH (Reno Kim, CEO of WONTECH, www.wtlaser.com) a leading Korean laser and energy based medical aesthetic device company announced that... fda clearance wontech receives hairboom https://www.philips.com/a-w/about/news/archive/standard/news/articles/2025/philips-receives-fda-510-k-clearance-for-cardiovascular-workspace.html FDA clearance for Philips Cardiovascular Workspace | Philips Philips has received FDA 510(k) clearance for its Cardiovascular Workspace. fda clearance for philips cardiovascular workspace https://www.usa.philips.com/a-w/about/news/archive/standard/news/press/2017/20170413-philips-fda-clearance-intellisite-pathology-solution-primary-diagnostic.html Philips receives FDA clearance to market Philips IntelliSite Pathology Solution for primary... Royal Philips today announced it has received regulatory clearance (via De Novo classification) from the U.S. Food and Drug Administration (FDA) to market... fda clearance to market solution for philips receives https://www.businesswire.com/news/home/20231017303952/en/Telesair-Receives-FDA-Clearance-for-Bonhawa-High-Flow-Oxygen-Therapy-System Telesair Receives FDA Clearance for Bonhawa High Flow Oxygen Therapy System Telesair, Inc., a technology leader in the respiratory industry, announced today that it has received FDA clearance to market its Bonhawa High Flow Oxygen Th... high flow oxygen therapy fda clearance telesair receives https://www.globenewswire.com/news-release/2024/07/15/2913045/0/en/Artelo-Biosciences-Receives-FDA-Clearance-of-its-IND-Application-for-ART26-12-a-Selective-Fatty-Acid-Binding-Protein-5-Inhibitor.html Artelo Biosciences Receives FDA Clearance of its IND ART26.12 seeks to address a critical need in painful neuropathies, including chemotherapy-induced peripheral neuropathy for which there is no FDA-approved... fda clearance biosciences receives ind https://markets.businessinsider.com/news/stocks/heartflow-announces-fda-clearance-of-plaque-analysis-algorithm-cigna-coverage-1035188259 Heartflow announces FDA clearance of plaque analysis algorithm, Cigna coverage | Markets Insider Heartflow (HTFL) announced it has received FDA 510 clearance for its Next Gen Heartflow Plaque Analysis algorithm and the platform is now availa... fda clearance plaque analysis https://www.usa.philips.com/a-w/about/news/archive/standard/news/press/2024/philips-zenition-90-motorized-receives-fda-510k-clearance-helping-clinicians-deliver-high-quality-care-with-a-high-powered-and-fast-motorized-mobile-c-arm.html FDA Clearance Philips Zenition 90 | Philips Philips Zenition 90 Motorized receives FDA 510(k) clearance, helping clinicians deliver high quality care with a high-powered and fast motorized mobile C-arm. fda clearance philips https://abbott.mediaroom.com/2024-04-01-Abbott-Receives-FDA-Clearance-for-Whole-Blood-Rapid-Test-to-Help-with-Assessment-of-Concussion-at-the-Patients-Bedside Abbott Receives FDA Clearance for Whole Blood Rapid Test to Help with Assessment of Concussion at... https://www.businesswire.com/news/home/20251210496502/en/Vektor-Medical-Receives-FDA-510k-Clearance-Adding-Atrial-Flutter-Mapping-Enhanced-Connectivity-and-New-Integration-Capabilities-to-Next-Generation-vMap Vektor Medical Receives FDA 510(k) Clearance Adding Atrial Flutter Mapping, Enhanced Connectivity... Vektor Medical, a medical technology company transforming cardiac arrhythmia care, today announced it has received FDA 510(k) clearance for its next-generati... https://www.businesswire.com/news/home/20200909005043/en/Apros-Therapeutics-Announces-IND-Clearance-from-U.S.-FDA-to-Initiate-the-Trial-of-APR003-an-Orally-Administered-GastrointestinalLiver-Targeted-TLR7-Agonist-for-Treatment-of-Advanced-Colorectal-Cancer-CRC-with-Malignant-Liver-Lesions Apros Therapeutics Announces IND Clearance from U.S. FDA to Initiate the Trial of APR003, an... Apros Therapeutics, Inc., a drug discovery and development company focused on tissue-targeted Toll-Like Receptor 7 (TLR7) agonists for the treatment of cance... https://appleinsider.com/articles/20/10/07/how-apple-sidestepped-fda-clearance-for-apple-watch-series-6-blood-oxygen-sensing Here's why Apple didn't need FDA clearance for Apple Watch Series 6 blood oxygen sensing |... While Apple went to great lengths to garner government approval for Apple Watch Series 4's ECG feature, the company didn't do the same for a blood oxygen... https://www.prnewswire.com/news-releases/innovative-aspiration-thrombectomy-system-by-expanse-ice-receives-fda-clearance-for-vessels-of-the-peripheral-arterial-and-venous-systems-302122988.html Innovative Aspiration Thrombectomy System by Expanse ICE Receives FDA Clearance for vessels of the... /PRNewswire/ -- Expanse ICE announced today the ICE Aspiration System has received 510(k) clearance from the U.S. Food and Drug Administration. This... https://www.prnewswire.com/news-releases/fda-clearance-issued-for-revolutionary-magnetic-compression-surgical-technique-soon-to-launch-in-us-market-302289053.html FDA clearance issued for revolutionary magnetic compression surgical technique soon to launch in... /PRNewswire/ -- GT Metabolic Solutions Inc., the global leader in magnetic compression anastomosis surgery, announced today that the U.S. Food and Drug... https://rss.globenewswire.com/fr/news-release/2023/10/10/2757389/0/en/Sleepiz-AG-Lands-FDA-510-k-Clearance-for-Contactless-Remote-Patient-Monitoring-Device-Measuring-Vital-Signs.html Sleepiz AG Lands FDA 510(k) Clearance for Contactless Sleepiz One+ device paves the way for patient monitoring devices in the U.S. through respiration rate, heart rate, and movement monitoring while at rest... ag lands fda k clearance https://www.businesswire.com/news/home/20260107798042/en/4Moving-Biotech-Receives-FDA-IND-Clearance-for-4P004-Strengthening-Its-Position-as-a-Leading-Innovator-in-Disease-Modifying-Osteoarthritis-Therapeutics 4Moving Biotech Receives FDA IND Clearance for 4P004, Strengthening Its Position as a Leading... 4Moving Biotech Receives FDA IND Clearance for 4P004 https://www.prnewswire.com/news-releases/millennium-dental-technologies-receives-first-of-its-kind-fda-clearance-for-tissue-regeneration-300270063.html Millennium Dental Technologies Receives First-of-Its Kind FDA Clearance for Tissue Regeneration /PRNewswire/ -- With periodontal disease evident in eighty-five percent of adults in the United States, Millennium Dental Technologies (MDT) is pleased to... first of its kind https://www.prnewswire.com/news-releases/soligenix-receives-fda-protocol-clearance-of-pivotal-phase-3-clinical-trial-of-sgx942-for-the-treatment-of-oral-mucositis-in-head-and-neck-cancer-patients-300449959.html Soligenix Receives FDA Protocol Clearance of Pivotal Phase 3 Clinical Trial of SGX942 for the... /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing... https://africananalyst.blogspot.com/2026/01/mrm-health-secures-fda-ind-clearance-to_0580493372.html African Analyst: MRM Health Secures FDA IND Clearance to Launch its Phase 2b Trial of MH002 in... (BUSINESS WIRE)--MRM Health NV, a clinical-stage biopharmaceutical company pioneering microbiome-based therapeutics for inflammatory disease... https://www.prnewswire.com/news-releases/gracell-biotechnologies-announces-fda-clearance-of-the-ind-application-for-phase-1b2-clinical-trial-of-fastcar-t-gc012f-for-the-treatment-of-relapsedrefractory-multiple-myeloma-301738212.html Gracell Biotechnologies Announces FDA Clearance of the IND Application for Phase 1b/2 Clinical... /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to... https://www.prnewswire.com/news-releases/accent-therapeutics-announces-fda-clearance-of-ind-application-for-atx-559-a-first-in-class-oral-dhx9-inhibitor-302285845.html Accent Therapeutics Announces FDA Clearance of IND Application for ATX-559, a First-In-Class Oral... Enables ATX-559 Phase 1 study in solid tumor patients with a focus on BRCA1/2-deficient breast cancer and solid tumors with microsatellite instability... https://www.businesswire.com/news/home/20230105005488/en/Azafaros-Receives-FDAs-IND-Clearance-and-Fast-Track-Designation-for-Lead-Asset-AZ-3102 Azafaros Receives FDA's IND Clearance and Fast Track Designation for Lead Asset AZ-3102 Azafaros B.V. today announced that it has received Investigational New Drug (IND) clearance from the United States Food and Drug Administration (FDA) to cond... https://www.businesswire.com/news/home/20251204253955/en/IDE034-a-Bispecific-ADC-Licensed-by-Biocytogen-to-IDEAYA-Receives-FDA-IND-Clearance IDE034, a Bispecific ADC Licensed by Biocytogen to IDEAYA, Receives FDA IND Clearance Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), announced that its partner IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision onc... https://www.businesswire.com/news/home/20260108244444/en/AccurKardia-Secures-FDA-510k-Clearance-of-and-Launches-AccurECG-2.0 AccurKardia Secures FDA 510(k) Clearance of and Launches AccurECG 2.0 AccurKardia, an ECG-led diagnostics software company focused on transforming ECG data into a more powerful diagnostic tool and broad biomarker to improve pat... https://www.businesswire.com/news/home/20251117980866/en/YolTech-Therapeutics-Receives-FDA-IND-Clearance-to-Initiate-Global-Pivotal-Trial-of-In-Vivo-Gene-Editing-Therapy-YOLT-203-for-Primary-Hyperoxaluria-Type-1-PH1?feedref=Zd8jjkgYuzBwDixoAdXmJgT1albrG1Eq4mAeVP39210g_8inYCwVWenMMPMB5WPWevRMp3sIgu8q3wq1OF24lT93qbEzrwa15HGbLqMObxZFg748y32SrN0cKdeprXDC0p7yTrReud89h-rHBR3Ndg%3D%3D YolTech Therapeutics Receives FDA IND Clearance to Initiate Global Pivotal Trial of In Vivo... YolTech Therapeutics, a clinical-stage biotechnology company developing next-generation in vivo gene editing therapies, today announced that the U.S. Food an... https://www.businesswire.com/news/home/20240122323895/en/Thirona-receives-FDA-510k-Clearance-for-LungQ-v3.0.0-Software-to-Power-AI-Analysis-of-Chest-CT-Images Thirona receives FDA 510(k) Clearance for LungQ v3.0.0 Software to Power AI Analysis of Chest CT... Thirona, a global company specializing in advanced analysis of thoracic CT images with artificial intelligence, announced that it has received U.S. Food and ... https://fdaauthority.com/fda-510k-clearance-process/ FDA 510(k) Clearance: Process and Requirements The 510k premarket notification pathway is the primary route through which Class II medical devices — and a subset of Class I devices — reach the U.S. market... clearance process fda k requirements https://appleinsider.com/articles/22/06/13/startup-gets-fda-clearance-to-use-apple-watch-to-monitor-parkinsons-symptoms Startup gets FDA clearance to use Apple Watch to monitor Parkinson's symptoms | AppleInsider Brain data firm Rune Labs has received Food and Drug Administration clearance to start using the Apple Watch to monitor symptoms in patients with Parkinson's... https://bluegoatcyber.com/ Medical Device Cybersecurity for FDA Clearance MedTech-only cybersecurity firm: pen testing, SBOMs, threat modeling, and SPDF docs that clear 510(k), De Novo, PMA, and IDE submissions. medical device cybersecurity fda clearance https://www.prnewswire.com/news-releases/liviwell-secures-fda-clearance-for-livi-introducing-a-new-category-in-post-intercourse-vaginal-care-302722627.html LiviWell Secures FDA Clearance for Livi, Introducing a New Category in Post-Intercourse Vaginal Care /PRNewswire/ -- LiviWell, a women's health company dedicated to developing innovative solutions for intimate health, today announced that the U.S. Food and... https://www.businesswire.com/news/home/20230308005894/en/Vertex-Announces-FDA-Clearance-of-Investigational-New-Drug-Application-for-VX-264-a-Novel-Encapsulated-Cell-Therapy-for-the-Treatment-of-Type-1-Diabetes?feedref=JjAwJuNHiystnCoBq_hl-RLXHJgazfQJNuOVHefdHP-D8R-QU5o2AvY8bhI9uvWSD8DYIYv4TIC1g1u0AKcacnnViVjtb72bOP4-4nHK5ieT3WxPE8m_kWI77F87CseT Vertex Announces FDA Clearance of Investigational New Drug Application for VX-264, a Novel... Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug ... https://innovate.research.ufl.edu/atsena-therapeutics-fda-clearance-retinoschisis/ Atsena Therapeutics Receives FDA Clearance of an Investigational Gene Therapy for X-Linked... The U.S. Food and Drug Administration (FDA) has cleared Atsena Therapeutics' Investigational New Drug (IND) application for a Phase I/II clinical trial of... https://www.newswire.ca/news-releases/see-mode-technologies-receives-fda-clearance-for-thyroid-ultrasound-ai-analysis-and-reporting-software-856342187.html See-Mode Technologies Receives FDA Clearance for Thyroid Ultrasound AI Analysis and Reporting... /CNW/ -- See-Mode Technologies, a global innovator in AI for ultrasound imaging, today announced the receipt of 510(k) clearance from the U.S. Food and Drug... https://consultqd.clevelandclinic.org/novel-urodynamic-system-receives-fda-clearance Novel Urodynamic System Receives FDA Clearance A novel urodynamic system, engineered and tested by Cleveland Clinic researchers and physicians, is one step closer to commercialization. urodynamic system novel receives fda clearance https://www.prnewswire.com/news-releases/onkos-surgical-receives-fda-510k-clearance-for-3d-printed-patient-specific-pelvic-reconstruction-system-301586720.html?tc=eml_cleartime Onkos Surgical Receives FDA 510(k) Clearance for 3D Printed, Patient-Specific Pelvic Reconstruction... /PRNewswire/ -- Onkos Surgical, a rapidly growing, leading innovator of solutions for musculoskeletal oncology and complex orthopaedic procedures, today... https://www.businesswire.com/news/home/20240801497942/en/Healx-Announces-%2447-million-Series-C-Financing-and-FDA-Clearance-of-Phase-2-IND-for-Neurofibromatosis-Type-1-Trial Healx Announces $47 million Series C Financing and FDA Clearance of Phase 2 IND for... Healx, an AI-enabled, clinical-stage biotech company specializing in rare diseases, announced it has raised $47 million in a Series C round. The Series C rou...