Gandjbakhche, Amir H.

Kanick, Stephen C.

Ramella-Roman, Jessica

Shadgan, Babak

Tromberg, Bruce J.

English

DigitalCommons@Florida International University

Florida International University FIU Digital Commons All Faculty 6-1-2021 Special Section Guest Editorial: Wearable, Implantable, Mobile, and Remote Biomedical Optics and Photonics Jessica Ramella-Roman Florida International University Amir H. Gandjbakhche National Institute of Child Health and Human Development (NICHD) Stephen C. Kanick PROFUSA Inc. Babak Shadgan The University of British Columbia Bruce J. Tromberg National Institute of Child Health and Human Development (NICHD) Follow this and additional works at: https://digitalcommons.fiu.edu/all_faculty Recommended Citation Ramella-Roman, Jessica; Gandjbakhche, Amir H.; Kanick, Stephen C.; Shadgan, Babak; and Tromberg, Bruce J., "Special Section Guest Editorial: Wearable, Implantable, Mobile, and Remote Biomedical Optics and Photonics" (2021). All Faculty. 375. https://digitalcommons.fiu.edu/all_faculty/375 This work is brought to you for free and open access by FIU Digital Commons. It has been accepted for inclusion in All Faculty by an authorized administrator of FIU Digital Commons. For more information, please contact dcc@fiu.edu. Special Section Guest Editorial: Wearable, Implantable,Mobile, and Remote Biomedical Optics and PhotonicsJessica Ramella-Roman,a Amir H. Gandjbakhche,b Stephen C. Kanick,cBabak Shadgan,d and Bruce J. TrombergeaFlorida International University, United StatesbNational Institute of Child Health and Human Development, United StatescProfusa Inc., United StatesdUniversity of British Columbia, CanadaeNational Institute of Child Health and Human Development, United StatesWe are pleased to introduce this JBO Special Section entitled “Wearable, Implantable, Mobile,and Remote Biomedical Optics & Photonics,” published as a 6-part series from August 2020 toJune 2021 and including seven articles which are summarized here below.The special section is inspired by the fast-paced advances in wearable and point-of-care tech-nologies of the last two decades. Devices such as smart watches, wearable heart rate monitors,and wearable blood pressure monitors are empowering individuals to not only meet fitnessprogress benchmarks but also achieve health and wellbeing goals. Point-of-care devices arebecoming accepted and integrated within the medical establishment, with an increase drivenby the pervasiveness of chronic and infectious diseases1 as well as the need of patient-centriccare. Industry is playing a phenomenal role in this growth. The point-of-care diagnostic marketsize was 34.49 billion dollars in 2020 and experienced a COVID-19-related growth of 73.5% inthe same year. It is expected to reach 81.37 billion in 2028.1 Restraining factors in this growth areregulatory policies that have at times slowed down, if not interrupted, the introduction of thesenovel medical devices. In that respect, there are promising signs from the U.S. Food and DrugAdministration (FDA): the Emergency Use Authorizations (EUAs)2 used during the pandemicfor both treatment and point of care system were essential in bringing both care and diagnostic inperiod of emergency, and the agency was also quick in revoking issued EUAwhen new evidencearose.3 Furthermore, the creation of the Digital Health Center of Excellence as an evolution ofthe Digital Health Program in the Center for Devices and Radiological Health shows an effort to“reimagine the FDA’s approach to ensuring all Americans have timely access to high-quality,safe, and effective digital health products” (see Ref. 4).In his prospective, “Perspective on the increasing role of optical wearables and remote patientmonitoring in the COVID-19 era and beyond,” Roblyer reports on the technological accelerationthat the COVID pandemic has created in the context of optical wearable and point of care. Hisreport outlines improvements in adoption of remote patient monitoring, wearables, and tele-health applications during the pandemic and beyond. Roblyer’s work provides an excellent sum-mary of both optically derived parameters currently in use in remote care, and parameters that aremost sought-after but remain to be developed.Several of the articles submitted to the special section focused on improvements on method-ologies for tissue oxygenation and perfusion that could be used in the management of a varietyof conditions, including COVID-related illnesses.Belcastro et al. (URL: https://doi.org/10.1117/1.JBO.25.8.082702) proposed a new designfor a compact low-cost RGB spectral frequency domain imager that utilizes a color CMOS cam-era and LED-based miniprojector. This study was motivated by the need for noninvasive andinexpensive imagers capable of achieving both structural and chemical information of livingtissue. Such system can be operated by lay individuals in remote settings. This work focuseson SFDI, a modality capable of separating the effects of scattering and absorption, whichrequires the spatial modulation of the source at specific frequencies. In the past, the use of acolor imager and white light projector has limited the application to three spectral bands© The Authors. Published by SPIE under a Creative Commons Attribution 4.0 Unported License. Distribution or reproduction of thiswork in whole or in part requires full attribution of the original publication, including its DOI.Journal of Biomedical Optics 062701-1 June 2021 • Vol. 26(6)Downloaded From: https://www.spiedigitallibrary.org/journals/Journal-of-Biomedical-Optics on 22 Aug 2022Terms of Use: https://www.spiedigitallibrary.org/terms-of-use(RGB); the work by Belcastro et al. extends the spectral capability to two more spectral bandsthrough a calibration procedure based on a separate spectrometer as well as camera spectralsensitivity characterization through a grating and white light illuminator. The approach was vali-dated with well characterized optical phantoms and in vivo on the skin of a volunteer.Liu et al. (URL: https://doi.org/10.1117/1.JBO.26.1.012705) developed a wearable fiber-free dual-wavelength diffuse speckle contrast flow oximetry system (DSCFO) for simultane-ous measurements of blood flow and oxygenation variations in deep tissues. Alterations indeep tissue hemodynamics are the hallmark of a variety of pathological conditions such ascerebral hypoxia, septic shock, peripheral artery disease, and even tumors, to name a few.The authors propose an extension of their previous work on single-wavelength diffuse specklecontrast flowmetry (DSCF) technique to diffuse speckle contrast flow oximetry (DSCFO), byadding a second wavelength sensitive to oxygenated hemoglobin to their system. Their appa-ratus is low cost and compact, consisting of two laser diodes and a small CMOS camera. Theuse of the camera improves the sampling rate while reducing the cost and dimension of theprobe. The authors utilize optical phantoms to demonstrate their system sensitivity and highsignal-to-noise ratio (SNR) as well as hemodynamic changes during artery cuff occlusion infive individuals.Koenig et al. (URL: https://doi.org/10.1117/1.JBO.26.1.012706) proposed a low-cost andwearable CMOS-based device for high-resolution spatial diffuse reflectance imaging of skinconditions. This system improves on current spatially resolved diffuse reflectance spectroscopy(srDRS) systems by not requiring expensive instrumentation, and fiber optics. This approachcircumvents the limitations of short source-detector separation by utilizing a fiber optic plate.Three light emitting diodes (LEDs) were used at 511, 615, and 660 nm. The system is controlledby a custom circuit board connected to a computer. The novel apparatus performance was com-pared to off-the-shelf clinical devices: an StO2 sensor and a PtCo2 sensor. Measurements wereconducted on 20 volunteers and generally good agreement was found between the low cost andcommercial-grade devices (5% to 10% discrepancy in StO2 characterization was found depend-ing on the analysis method), although two separate analysis methods were necessary at thisstage. The authors point out the sensitivity of their system to skin tone, which is alleviatedby the use of skin-matched (dark, light) reference samples.Pai et al. (URL: https://doi.org/10.1117/1.JBO.26.2.022707) proposed a non-contact heartrate variability (HRV) algorithm utilizing common cameras. Remote and noncontact estimationof heart rate variability has many applications. These measurements commonly suffer from lowSNR, due to the absorption properties of skin as well as unpredictable illumination and move-ment artifacts. The author’s approach improves on current methods by utilizing an automaticadaptive bandwidth filtering and discrete energy separation to estimate the instantaneous fre-quency of an image photoplethysmography signal. Both the algorithm and data set of 12 indi-viduals utilized in this study are made available.Implantable devices are becoming more popular as a way to manage chronic disease. A suc-cessful example of this application are glucose monitors which are implanted in the patient sub-cutis and interfaced to wearable systems for data monitoring and analysis. Cao et al. (URL:https://doi.org/10.1117/1.JBO.25.11.112704) proposed a new application for implantable sen-sors: the measurement of tissue oxygenation during radiotherapy in combination withCherenkov-excited luminescence imaging (CELI). Studies have shown that oxygen enhancesthe radiobiologic damage improving cancer treatment outcome while the opposite has beenshown in hypoxic environments. The sensor consists of an agarose matrix with a PtG4, an oxy-gen quenched dendritic molecule. It was tested both in phantoms and in an in-vivo tumor modelundergoing fractionated radiotherapy.Finally, Spink et al. (URL: https://doi.org/10.1117/1.JBO.26.6.062708) demonstrated thedesign and realization of a high optode-density wearable continuous wave diffuse optical probefor the monitoring of breathing hemodynamics in breast tissue. This work is motivated by theneed to predict neoadjuvant chemotherapy (NAC) treatment response for locally advanced breastcancer patients. The probe was fabricated on a flexible 6 cm x 6 cm printed circuit board popu-lated with 32 LED (750 and 850 nm) and 16 optical silicon detectors. Validation was conductedwith both optical phantoms and in vivo with a cuff occlusion experiment as well as in a breaststudy of healthy volunteers.Special Section Guest EditorialJournal of Biomedical Optics 062701-2 June 2021 • Vol. 26(6)Downloaded From: https://www.spiedigitallibrary.org/journals/Journal-of-Biomedical-Optics on 22 Aug 2022Terms of Use: https://www.spiedigitallibrary.org/terms-of-useThe future is bright for research related to wearable and point-of-care technology. As illus-trated by the investigators participating in this special section, optical science is bound to play afundamental role in the advancement of integration in standard of care. We thank all the con-tributors and JBO editorial and production staff for their assistance.DisclosuresThe authors declare no conflicts of interest.AcknowledgmentsDr. Ramella-Roman acknowledges partial support from NSF: ERC 1648451(PATHS-UP) aswell as Christopher Finberg for the interesting discussion.References1. Fortune Business Insights, “Point of care diagnostics market,” May 2021, https://www.fortunebusinessinsights.com/industry-reports/point-of-care-diagnostics-market-101072 (accessed 15June 2021).2. U.S. Food and Drug Administration, “Emergency use authorization of medical products andrelated authorities, guidance for industry,” 2017, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities (accessed 15 June 2021).3. U.S. Food and Drug Administration, “Emergency use authorization for vaccines explained,”2020, https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained (accessed 15 June 2021).4. U.S. Food and Drug Administration, “Digital Health Center of Excellence,” 2020, https://www.fda.gov/medical-devices/digital-health-center-excellence/about-digital-health-center-excellence#what (accessed 15 June 2021).Jessica C. Ramella-Roman is an associate professor at Florida International University.She received her Laura from University of Pavia in Italy and MS and PhD degrees in electricalengineering from the Oregon Health and Science University in 2004. She is the author ofmore than 70 journal papers and has written four book chapters. Her current research interestsinclude the design of wearable and point-of-care devices, polarized light imaging and sensing,and multi-modal microscopy. She is a fellow of SPIE.Amir H. Gandjbakhche is a senior investigator and head of the Section on TranslationalBiophotonics, and deputy associate director of the Division of Translational Imaging andGenomics Integrity at NICHD. He obtained his PhD in physics with a biomedical engineeringspecialty from the University of Paris in 1989. He is a fellow of SPIE, the largest society ofoptical engineers, and Optical Society of America. He leads a research group that uses differentoptical sources of contrast such as endogenous or exogenous fluorescent labels, absorption (e.g.,hemoglobin or chromophore concentration) in order to devise quantitative theories at the board,and designs instrumentation at the bench, and brings the imaging system to the bedside. Areas ofinterest are the use of near infrared spectroscopy/EEG to applied to developmental disorders anddiseases such as cognitive function in Traumatic Brain Injury and Autistic Spectrum Disorder,and using spectroscopic methods to quantify oxygenation in placenta.Stephen C. Kanick is the data science lead for Profusa Inc., a startup that develops biocom-patible subcutaneous biosensors that continuously monitor tissue analytes. Previously, he was anassistant professor of engineering in the Thayer School of Engineering at Dartmouth College,where he still currently holds an adjunct appointment. He completed a postdoctoral appointmentin the Center for Optical Diagnostics and Therapy at the Erasmus Medical Center in Rotterdam,Special Section Guest EditorialJournal of Biomedical Optics 062701-3 June 2021 • Vol. 26(6)Downloaded From: https://www.spiedigitallibrary.org/journals/Journal-of-Biomedical-Optics on 22 Aug 2022Terms of Use: https://www.spiedigitallibrary.org/terms-of-usethe Netherlands. He holds a BS degree in chemical engineering from West Virginia University,and both MS and PhD degrees in Chemical Engineering from the University of Pittsburgh. Hisresearch focuses on the development of new quantitative spectroscopy approaches that are usedfor diagnosing pathologies, guiding surgeries, and monitoring administered therapies. He hasauthored 50 peer-reviewed publications and has received a Career Development Award(K25) from the National Cancer Institute.Babak Shadgan is a medical doctor specialized in Sports Medicine and Clinical Biophotonics.He is an assistant professor at the Department of Orthopaedics, the University of BritishColumbia, with an associate faculty appointment at the UBC School of Biomedical Engineering.He received his MD degree in 1994, an MSc in sports medicine from the University of London in2001 and a PhD in clinical biophotonics from the University of British Columbia (UBC) in 2011.He also completed a fellowship on NIRS-Diffused Optical Tomography at Martinos Center forBiomedical Imaging of MIT/Harvard University. His postdoctoral fellowship at ICORD (theInternational Collaboration on Repair Discoveries) focused on remote optical monitoring ofbladder dysfunction in people with spinal cord injury. With more than two decades of medicalpractice and research, he has developed a specific knowledge in clinical biophotonics with aunique bedside-to-bench approach. His current research focuses on advancing novel implantableand wearable methods for real-time monitoring of internal organ and tissue hemodynamics,metabolism, and function in health and diseases. As an Olympic sports physician and medicaldirector, he is actively working on sports and exercise applications of biophotonics. He is cur-rently involved in developing optical diagnostics and monitoring interventions in sports medi-cine and exercise sciences. He chairs the “Biophotonics in Exercise Science, Sports Medicine,Health Monitoring Technologies, and Wearables” BIOS conference and teaches “Fundamentalsof Applied Pathophysiology in Biomedical Engineering” at SPIE.Bruce J. Tromberg is the director of the National Institute of Biomedical Imaging andBioengineering (NIBIB) at the National Institutes of Health (NIH). Prior to joining NIH inJanuary 2019, he was a professor of biomedical engineering and surgery at the University ofCalifornia, Irvine (UCI) and director of the Beckman Laser Institute and Medical Clinic(BLIMC). He specializes in the development of optics and photonics technologies for bio-medical imaging and therapy as well as bench-to-bedside clinical translation, validation, andcommercialization of new devices. Dr. Tromberg is a fellow of SPIE, OSA, and the AmericanInstitute for Medical and Biological Engineers (AIMBE).Special Section Guest EditorialJournal of Biomedical Optics 062701-4 June 2021 • Vol. 26(6)Downloaded From: https://www.spiedigitallibrary.org/journals/Journal-of-Biomedical-Optics on 22 Aug 2022Terms of Use: https://www.spiedigitallibrary.org/terms-of-use

Special Section Guest Editorial: Wearable, Implantable, Mobile, and Remote Biomedical Optics and Photonics

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Special Section Guest Editorial: Wearable, Implantable, Mobile, and Remote Biomedical Optics and Photonics

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