https://www.nsmedicaldevices.com/news/clew-medical-secures-fda-clearance-for-second-generation-ai-models/
CLEW Medical Secures FDA Clearance for Second-Generation AI Models - NS Medical Devices
May 24, 2024 - Predictions from the CLEW platform were at least five times more accurate than alerts from the leading telemedicine system and generated 50 times fewer alarms...
secures fda clearanceclewai
https://www.nsmedicaldevices.com/news/indica-labs-secures-fda-nod-for-halo-ap-dx-digital-pathology-platform/
Indica Labs secures FDA nod for HALO AP Dx digital pathology platform
May 9, 2024 - Indica Labs has secured the US Food and Drug Administration (FDA) 510(k) clearance for its enterprise digital pathology platform, HALO AP Dx.
labs securesfda nodindicahalo
https://www.nsmedicaldevices.com/news/roche-hpv-self-collection-solution/
Roche secures FDA approval for its HPV self-collection solution
May 17, 2024 - Roche has received the US Food and Drug Administration (FDA) approval for its human papillomavirus (HPV) self-collection solution.
secures fdaself collectionhpv
https://www.bioworld.com/articles/727574-naox-secures-fda-clearance-for-eeg-earbuds?v=preview
Naox secures FDA clearance for EEG earbuds | BioWorld
Naox Technologies SAS secured U.S. FDA 510(k) clearance for Naox Link, its in-ear electroencephalography (EEG) device for clinical use both at home and in...
secures fda clearancenaoxeeg
https://www.nsmedicaldevices.com/news/orthofix-fda-approval-rodeo-telescopic-nail/
Orthofix secures FDA 510(k) approval for Rodeo Telescopic Nail
May 10, 2024 - US-based Orthofix Medical has received the US Food and Drug Administration (FDA) 510(k) approval to market its Rodeo Telescopic Nail.
secures fdak approvalorthofix
https://www.streetwisereports.com/article/2025/10/01/biotech-secures-fda-alignment-on-late-stage-duchenne-therapy.html?m_t=2025_10_01_07_27_12
Biotech Secures FDA Alignment on Late-Stage Duchenne Therapy
Capricor Therapeutics Inc. (CAPR:NASDAQ) reached agreement with the FDA to include HOPE-3 trial data in its BLA for Deramiocel, its cell therapy for Duchenne...
late stage duchennebiotechfda
https://www.nsmedicaldevices.com/news/ihealth-covid-19-and-flu-ab-rapid-test/
iHealth secures FDA EUA for its Covid-19 and Flu A&B Rapid Test
secures fdaihealtheuacovidflu
https://www.nsmedicaldevices.com/news/meditrina-new-generation-aveta-system/
Meditrina secures FDA 510(k) approval for new-gen Aveta system
May 20, 2024 - Meditrina has received the US Food and Drug Administration (FDA) 510(k) approval for the second-generation Aveta system.
meditrina securesk approval
https://www.nsmedicaldevices.com/news/oxehealth-sleep-monitoring-solution/
Oxehealth secures FDA and CE mark for sleep monitoring solution
May 16, 2024 - Oxehealth has received US Food and Drug Administration (FDA) and CE Mark approvals for its new sleep monitoring solution.
secures fdace marksleep