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Delcath Inc fda- approved device
Fda Approved Device, supplied by Delcath Inc, used in various techniques. Bioz Stars score: 90/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
https://www.bioz.com/product/fda-+approved+device/fda++approved+device/pm39402738-528-24-26
Average 90 stars, based on 1 article reviews
fda- approved device - by Bioz Stars, 2026-10
90/100 stars

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Article Title: PASPCR 2024 Annual Meeting, New York, NY.
Article Snippet: A. Fateeva1,2, S. Chen1,2,3,4 1Susan Lehman Cullman Laboratory for Cancer Research, Rutgers University, Piscataway, NJ, USA, 2Graduate Program in Cellular and Molecular Pharmacology, School of Graduate Studies Rutgers University, Piscataway, NJ, USA, 3Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA, 4Environmental & Occupational Health Sciences Institute, Rutgers University, Piscataway, NJ, USA



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Small animal fluorescence imaging systems ( a ) Pearl and ( b ) IVIS SpectrumCT equipped with enclosed, light-tight imaging chambers to minimize ambient light. c Advanced CVG platform for preclinical and clinical NIR cancer imaging. Cart-based clinical FGS systems ( d ) Quest Spectrum and ( e ) Stryker SPY-PHI equipped with a handheld camera/light tethered by power and network cords.

Journal: npj Imaging

Article Title: Bridging preclinical and clinical fluorescence-guided surgery with advanced cancer vision goggles

doi: 10.1038/s44303-026-00170-x

Figure Lengend Snippet: Small animal fluorescence imaging systems ( a ) Pearl and ( b ) IVIS SpectrumCT equipped with enclosed, light-tight imaging chambers to minimize ambient light. c Advanced CVG platform for preclinical and clinical NIR cancer imaging. Cart-based clinical FGS systems ( d ) Quest Spectrum and ( e ) Stryker SPY-PHI equipped with a handheld camera/light tethered by power and network cords.

Article Snippet: To evaluate the performance of CVG fluorescence detection in the OR setting, we compared the CVG platform to the FDA-approved Stryker SPY-PHI handheld FGS device, imaging resected tumor tissues from patients undergoing head and neck cancer surgery (Fig. ).

Techniques: Fluorescence, Imaging

a Excitation and emission spectra of LS301 and preclinical FGS workflow (created with Biorender). b – e , Representative composite images showing pseudocolored NIR fluorescence overlaid on grayscale brightfield images of BALB/c mice ( n = 3) bearing subcutaneous 4T1 tumors ~24 h after intravenous injection of LS301-HSA (30 µM, 100 µL demonstrating FGS for tumor resection acquired with: ( b ) CVG – inset numbers indicate real-time quantitative fluorescence values at various signal thresholds; ( c ) Pearl – color scale [min = 4.70 × 10⁻², max = 3.22 × 10⁻¹]; ( d ) IVIS – color scale [min = 350, max = 2000]; ( e ) Quest Spectrum (Quest) – non-quantitative handheld imaging of dorsal flank regions. Panels from left to right show pre-surgery, exposed tumor after skin deflection, the post-resection, and after incision closure. Ex vivo imaging includes intact tumor (superficial—front; deep—back side), as well as 1.5-mm thick tumor slices. Tumor regions were delineated freehand based on fluorescence intensity and designated by dotted orange lines. f TNRs for CVG, Pearl, and IVIS were not significantly different, while CVG showed significantly higher TNR compared to Quest Spectrum ( P = 0.016). The red-circled area indicates the tumor ROI, while the white-circled area indicates the nontumor ROI in ( b – e ), which were selected for the TNR analysis. Data represent mean ± SD of TNRs from three mice. P values were calculated using one-way ANOVA with multiple comparisons in Prism 8.0.1. Scale bar: 5 mm.

Journal: npj Imaging

Article Title: Bridging preclinical and clinical fluorescence-guided surgery with advanced cancer vision goggles

doi: 10.1038/s44303-026-00170-x

Figure Lengend Snippet: a Excitation and emission spectra of LS301 and preclinical FGS workflow (created with Biorender). b – e , Representative composite images showing pseudocolored NIR fluorescence overlaid on grayscale brightfield images of BALB/c mice ( n = 3) bearing subcutaneous 4T1 tumors ~24 h after intravenous injection of LS301-HSA (30 µM, 100 µL demonstrating FGS for tumor resection acquired with: ( b ) CVG – inset numbers indicate real-time quantitative fluorescence values at various signal thresholds; ( c ) Pearl – color scale [min = 4.70 × 10⁻², max = 3.22 × 10⁻¹]; ( d ) IVIS – color scale [min = 350, max = 2000]; ( e ) Quest Spectrum (Quest) – non-quantitative handheld imaging of dorsal flank regions. Panels from left to right show pre-surgery, exposed tumor after skin deflection, the post-resection, and after incision closure. Ex vivo imaging includes intact tumor (superficial—front; deep—back side), as well as 1.5-mm thick tumor slices. Tumor regions were delineated freehand based on fluorescence intensity and designated by dotted orange lines. f TNRs for CVG, Pearl, and IVIS were not significantly different, while CVG showed significantly higher TNR compared to Quest Spectrum ( P = 0.016). The red-circled area indicates the tumor ROI, while the white-circled area indicates the nontumor ROI in ( b – e ), which were selected for the TNR analysis. Data represent mean ± SD of TNRs from three mice. P values were calculated using one-way ANOVA with multiple comparisons in Prism 8.0.1. Scale bar: 5 mm.

Article Snippet: To evaluate the performance of CVG fluorescence detection in the OR setting, we compared the CVG platform to the FDA-approved Stryker SPY-PHI handheld FGS device, imaging resected tumor tissues from patients undergoing head and neck cancer surgery (Fig. ).

Techniques: Fluorescence, Injection, Imaging, Ex Vivo

a Representative visible-light image captured by CVG. b Pseudocolored NIR fluorescence overlay generated using a dynamic thresholding algorithm, overlaid on the visible image. The three boxed values represent fluorescence intensity thresholds for the top 10%, top 5%, and maximum intensity pixels. CVG images were acquired at a resolution of 480 × 640 (height × width) pixels from a fixed 50 cm working distance. c Visible image of the same tissue captured by the handheld Stryker SPY-PHI system (SPY-PHI). d NIR fluorescence (blue-to-red pseudocolor) overlaid on grayscale white-light image obtained by the Stryker SPY-PHI system in SPY-CSF mode. e Raw NIR fluorescence image from CVG. f , NIR fluorescence image obtained by the Stryker SPY-PHI system in SPY contrast mode. g Overlay of the top 15% fluorescence intensity pixels from the CVG NIR image (red) and the transformed Stryker SPY-PHI NIR image (green) in an RGB composite; yellow indicates overlapping regions. h Dice coefficient comparing the top 15% pixels from both systems: 0.84 ± 0.04 ( n = 6), with two outliers shown as brown dots (0.50 and 0.59). i Normalized intensity map (NIM) derived from the CVG NIR grayscale image, showing a mean of 19.84 ± 14.23 and a maximum of 54.93. j NIM from the transformed SPY-PHI image, with a mean of 2.76 ± 1.28 and a maximum of 4.77. Both NIMs were normalized by the mean intensity of the lowest 10% of pixels in the tissue sample. k Overlay of high-intensity NIM regions (NIM > 1.5) from CVG (red) and Stryker SPY-PHI (green) in RGB format, where yellow indicates overlap. l , Dice coefficient for NIM > 1.5 comparison: 0.91 ± 0.02 ( n = 6). Scale bars, 5 mm.

Journal: npj Imaging

Article Title: Bridging preclinical and clinical fluorescence-guided surgery with advanced cancer vision goggles

doi: 10.1038/s44303-026-00170-x

Figure Lengend Snippet: a Representative visible-light image captured by CVG. b Pseudocolored NIR fluorescence overlay generated using a dynamic thresholding algorithm, overlaid on the visible image. The three boxed values represent fluorescence intensity thresholds for the top 10%, top 5%, and maximum intensity pixels. CVG images were acquired at a resolution of 480 × 640 (height × width) pixels from a fixed 50 cm working distance. c Visible image of the same tissue captured by the handheld Stryker SPY-PHI system (SPY-PHI). d NIR fluorescence (blue-to-red pseudocolor) overlaid on grayscale white-light image obtained by the Stryker SPY-PHI system in SPY-CSF mode. e Raw NIR fluorescence image from CVG. f , NIR fluorescence image obtained by the Stryker SPY-PHI system in SPY contrast mode. g Overlay of the top 15% fluorescence intensity pixels from the CVG NIR image (red) and the transformed Stryker SPY-PHI NIR image (green) in an RGB composite; yellow indicates overlapping regions. h Dice coefficient comparing the top 15% pixels from both systems: 0.84 ± 0.04 ( n = 6), with two outliers shown as brown dots (0.50 and 0.59). i Normalized intensity map (NIM) derived from the CVG NIR grayscale image, showing a mean of 19.84 ± 14.23 and a maximum of 54.93. j NIM from the transformed SPY-PHI image, with a mean of 2.76 ± 1.28 and a maximum of 4.77. Both NIMs were normalized by the mean intensity of the lowest 10% of pixels in the tissue sample. k Overlay of high-intensity NIM regions (NIM > 1.5) from CVG (red) and Stryker SPY-PHI (green) in RGB format, where yellow indicates overlap. l , Dice coefficient for NIM > 1.5 comparison: 0.91 ± 0.02 ( n = 6). Scale bars, 5 mm.

Article Snippet: To evaluate the performance of CVG fluorescence detection in the OR setting, we compared the CVG platform to the FDA-approved Stryker SPY-PHI handheld FGS device, imaging resected tumor tissues from patients undergoing head and neck cancer surgery (Fig. ).

Techniques: Fluorescence, Generated, Transformation Assay, Derivative Assay, Comparison

Fig. 1. An illustration of the neuromodulation setup. Three electrode positions, namely F4, P4, and T8, were connected via wires to a rechargeable battery.

Journal: Neuroscience letters

Article Title: Neural consequences of 5-Hz transcranial alternating current stimulation over right hemisphere: An eLORETA EEG study.

doi: 10.1016/j.neulet.2024.137849

Figure Lengend Snippet: Fig. 1. An illustration of the neuromodulation setup. Three electrode positions, namely F4, P4, and T8, were connected via wires to a rechargeable battery.

Article Snippet: We utilized Starstim-8, an FDA-approved neuromodulation device developed by Neuroelectrics, Inc., to treat anxiety disorders.

Techniques: Battery

Reports identified using the search terms on correlation between electrode angular insertion depth and hearing outcomes (references in <xref ref-type= Supplementary material S2 )." width="100%" height="100%">

Journal: Frontiers in Neurology

Article Title: Cochlear implant electrode design for safe and effective treatment

doi: 10.3389/fneur.2024.1348439

Figure Lengend Snippet: Reports identified using the search terms on correlation between electrode angular insertion depth and hearing outcomes (references in Supplementary material S2 ).

Article Snippet: 9 , Selleck et al. (2019) , USA , All three FDA-approved CI devices , — , Positive.

Techniques: Variant Assay