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

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

BioPixS Ltd.
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: Contribution to journal › Article › 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
Article number	EM1A.9
Journal	Optics InfoBase Conference Papers
Publication status	Published - 2021
Event	2021 European Conferences on Biomedical Optics, ECBO 2021 - Virtual, Online, Germany Duration: 20 Jun 2021 → 24 Jun 2021

Cite this

Sekar, S. K. V., Guadagno, C. N., 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. Optics InfoBase Conference Papers, Article EM1A.9.

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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 = "Sekar, \{Sanathana Konugolu Venkata\} and Guadagno, \{Claudia Nunzia\} 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} 2021 The Author(s); 2021 European Conferences on Biomedical Optics, ECBO 2021 ; Conference date: 20-06-2021 Through 24-06-2021",

year = "2021",

language = "English",

journal = "Optics InfoBase Conference Papers",

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Sekar, SKV, Guadagno, CN, 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', Optics InfoBase Conference Papers.

TY - JOUR

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

T2 - 2021 European Conferences on Biomedical Optics, ECBO 2021

AU - Sekar, Sanathana Konugolu Venkata

AU - Guadagno, Claudia Nunzia

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.

UR - https://www.scopus.com/pages/publications/85119445410

M3 - Article

AN - SCOPUS:85119445410

SN - 2162-2701

JO - Optics InfoBase Conference Papers

JF - Optics InfoBase Conference Papers

M1 - EM1A.9

Y2 - 20 June 2021 through 24 June 2021

ER -

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

Abstract

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