Phantoms for performance verification and quality control in developing a photonics-based medical device (VASCOVID): A regulatory driven approach

Sanathana Konugolu Venkata Sekar; Claudia Nunzia Guadagno; Marta Zanoletti; Lorenzo Cortese; Marco Pagliazzi; Pranav Lanka; Rainer Rothe Munoz; Eduardo Garrido; Talyta Carteano; Michele Lacerenza; Mauro Buttafava; Shahrzad Parsa; Udo M. Weigel; Alessandro Torricelli; Antonio Pifferi; Davide Contini; Turgut Durduran; Stefan Andersson-Engels

doi:10.1117/12.2615398

Phantoms for performance verification and quality control in developing a photonics-based medical device (VASCOVID): A regulatory driven approach

Sanathana Konugolu Venkata Sekar
, Claudia Nunzia Guadagno
, Marta Zanoletti
, Lorenzo Cortese
, Marco Pagliazzi
, Pranav Lanka
, Rainer Rothe Munoz
, Eduardo Garrido
, Talyta Carteano
, Michele Lacerenza
, Mauro Buttafava
, Shahrzad Parsa
, Udo M. Weigel
, Alessandro Torricelli
, Antonio Pifferi
, Davide Contini
, Turgut Durduran
, Stefan Andersson-Engels

Tyndall Photonics

BioPixS Ltd.
The Barcelona Institute of Science and Technology
Polytechnic University of Milan
ASPHALION SL
PIONIRS SRL
HemoPhotonics S.L.
National Research Council of Italy
ICREA

Research output: Chapter in Book/Report/Conference proceedings › Conference proceeding › peer-review

Abstract

We propose a standardized approach for performance assessment and quality-control of the novel VASCOVID system based on optical phantoms. This approach is tailored to meet the requirements of the Medical Device Regulation, and is extendable to other biophotonics devices.

Original language	English
Title of host publication	Diffuse Optical Spectroscopy and Imaging VIII
Editors	Davide Contini, Yoko Hoshi, Thomas D. O'Sullivan
Publisher	SPIE
ISBN (Electronic)	9781510647060
DOIs	https://doi.org/10.1117/12.2615398
Publication status	Published - 2021
Event	Diffuse Optical Spectroscopy and Imaging VIII 2021 - Virtual, Online, Germany Duration: 20 Jun 2021 → 24 Jun 2021

Publication series

Name	Progress in Biomedical Optics and Imaging - Proceedings of SPIE
Volume	11920
ISSN (Print)	1605-7422

Conference

Conference	Diffuse Optical Spectroscopy and Imaging VIII 2021
Country/Territory	Germany
City	Virtual, Online
Period	20/06/21 → 24/06/21

Access to Document

10.1117/12.2615398

Cite this

Venkata Sekar, S. K., Nunzia Guadagno, C., Zanoletti, M., Cortese, L., Pagliazzi, M., Lanka, P., Munoz, R. R., Garrido, E., Carteano, T., Lacerenza, M., Buttafava, M., Parsa, S., Weigel, U. M., Torricelli, A., Pifferi, A., Contini, D., Durduran, T., & Andersson-Engels, S. (2021). Phantoms for performance verification and quality control in developing a photonics-based medical device (VASCOVID): A regulatory driven approach. In D. Contini, Y. Hoshi, & T. D. O'Sullivan (Eds.), Diffuse Optical Spectroscopy and Imaging VIII Article 119201Q (Progress in Biomedical Optics and Imaging - Proceedings of SPIE; Vol. 11920). SPIE. https://doi.org/10.1117/12.2615398

Venkata Sekar, Sanathana Konugolu ; Nunzia Guadagno, Claudia ; Zanoletti, Marta et al. / Phantoms for performance verification and quality control in developing a photonics-based medical device (VASCOVID) : A regulatory driven approach. Diffuse Optical Spectroscopy and Imaging VIII. editor / Davide Contini ; Yoko Hoshi ; Thomas D. O'Sullivan. SPIE, 2021. (Progress in Biomedical Optics and Imaging - Proceedings of SPIE).

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title = "Phantoms for performance verification and quality control in developing a photonics-based medical device (VASCOVID): A regulatory driven approach",

abstract = "We propose a standardized approach for performance assessment and quality-control of the novel VASCOVID system based on optical phantoms. This approach is tailored to meet the requirements of the Medical Device Regulation, and is extendable to other biophotonics devices.",

author = "\{Venkata Sekar\}, \{Sanathana Konugolu\} and \{Nunzia Guadagno\}, Claudia and Marta Zanoletti and Lorenzo Cortese and Marco Pagliazzi and Pranav Lanka and Munoz, \{Rainer Rothe\} and Eduardo Garrido and Talyta Carteano and Michele Lacerenza and Mauro Buttafava and Shahrzad Parsa and Weigel, \{Udo M.\} and Alessandro Torricelli and Antonio Pifferi and Davide Contini and Turgut Durduran and Stefan Andersson-Engels",

note = "Publisher Copyright: {\textcopyright} COPYRIGHT SPIE. Downloading of the abstract is permitted for personal use only.; Diffuse Optical Spectroscopy and Imaging VIII 2021 ; Conference date: 20-06-2021 Through 24-06-2021",

year = "2021",

doi = "10.1117/12.2615398",

language = "English",

series = "Progress in Biomedical Optics and Imaging - Proceedings of SPIE",

publisher = "SPIE",

editor = "Davide Contini and Yoko Hoshi and O'Sullivan, \{Thomas D.\}",

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Venkata Sekar, SK, Nunzia Guadagno, C, Zanoletti, M, Cortese, L, Pagliazzi, M, Lanka, P, Munoz, RR, Garrido, E, Carteano, T, Lacerenza, M, Buttafava, M, Parsa, S, Weigel, UM, Torricelli, A, Pifferi, A, Contini, D, Durduran, T & Andersson-Engels, S 2021, Phantoms for performance verification and quality control in developing a photonics-based medical device (VASCOVID): A regulatory driven approach. in D Contini, Y Hoshi & TD O'Sullivan (eds), Diffuse Optical Spectroscopy and Imaging VIII., 119201Q, Progress in Biomedical Optics and Imaging - Proceedings of SPIE, vol. 11920, SPIE, Diffuse Optical Spectroscopy and Imaging VIII 2021, Virtual, Online, Germany, 20/06/21. https://doi.org/10.1117/12.2615398

Phantoms for performance verification and quality control in developing a photonics-based medical device (VASCOVID): A regulatory driven approach. / Venkata Sekar, Sanathana Konugolu; Nunzia Guadagno, Claudia; Zanoletti, Marta et al.
Diffuse Optical Spectroscopy and Imaging VIII. ed. / Davide Contini; Yoko Hoshi; Thomas D. O'Sullivan. SPIE, 2021. 119201Q (Progress in Biomedical Optics and Imaging - Proceedings of SPIE; Vol. 11920).

Research output: Chapter in Book/Report/Conference proceedings › Conference proceeding › peer-review

TY - GEN

T1 - Phantoms for performance verification and quality control in developing a photonics-based medical device (VASCOVID)

T2 - Diffuse Optical Spectroscopy and Imaging VIII 2021

AU - Venkata Sekar, Sanathana Konugolu

AU - Nunzia Guadagno, Claudia

AU - Zanoletti, Marta

AU - Cortese, Lorenzo

AU - Pagliazzi, Marco

AU - Lanka, Pranav

AU - Munoz, Rainer Rothe

AU - Garrido, Eduardo

AU - Carteano, Talyta

AU - Lacerenza, Michele

AU - Buttafava, Mauro

AU - Parsa, Shahrzad

AU - Weigel, Udo M.

AU - Torricelli, Alessandro

AU - Pifferi, Antonio

AU - Contini, Davide

AU - Durduran, Turgut

AU - Andersson-Engels, Stefan

PY - 2021

Y1 - 2021

N2 - We propose a standardized approach for performance assessment and quality-control of the novel VASCOVID system based on optical phantoms. This approach is tailored to meet the requirements of the Medical Device Regulation, and is extendable to other biophotonics devices.

AB - We propose a standardized approach for performance assessment and quality-control of the novel VASCOVID system based on optical phantoms. This approach is tailored to meet the requirements of the Medical Device Regulation, and is extendable to other biophotonics devices.

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U2 - 10.1117/12.2615398

DO - 10.1117/12.2615398

M3 - Conference proceeding

AN - SCOPUS:85122848238

T3 - Progress in Biomedical Optics and Imaging - Proceedings of SPIE

BT - Diffuse Optical Spectroscopy and Imaging VIII

A2 - Contini, Davide

A2 - Hoshi, Yoko

A2 - O'Sullivan, Thomas D.

PB - SPIE

Y2 - 20 June 2021 through 24 June 2021

ER -

Venkata Sekar SK, Nunzia Guadagno C, Zanoletti M, Cortese L, Pagliazzi M, Lanka P et al. Phantoms for performance verification and quality control in developing a photonics-based medical device (VASCOVID): A regulatory driven approach. In Contini D, Hoshi Y, O'Sullivan TD, editors, Diffuse Optical Spectroscopy and Imaging VIII. SPIE. 2021. 119201Q. (Progress in Biomedical Optics and Imaging - Proceedings of SPIE). doi: 10.1117/12.2615398

Phantoms for performance verification and quality control in developing a photonics-based medical device (VASCOVID): A regulatory driven approach

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