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fully edited. Content may change prior to final publication. Citation information: DOI 10.1109/JETCAS.2018.2812105, IEEE Journal
on Emerging and Selected Topics in Circuits and Systems
JETCAS-2017-0102 1
Abstract— The purpose of this paper is to develop and validate I. INTRODUCTION
a miniature system that can wirelessly acquire gastric electrical
activity called slow waves, and deliver high energy electrical
pulses to modulate its activity. The system is composed of a front- G ASTROINTESTINAL (GI) motility is coordinated by
underlying bio-electrical events known as slow waves.
Abnormalities in slow waves have been implicated in major
end unit, and an external stationary back-end unit that is
connected to a computer. The front-end unit contains a recording functional motility disorders such as gastroparesis, chronic
module with three channels, and a single-channel stimulation nausea and unexplained vomiting, and functional dyspepsia
module. Commercial off-the-shelf components were used to [1]. Current management options are mainly limited to
develop front- and back-end units. A graphical user interface was
symptomatic and prokinetic therapies, with many patients
designed in LabVIEW to process and display the recorded data
in real-time, and store the data for off-line analysis. The system incompletely treated. Gastric electrical stimulation (GES) has
was successfully validated on bench top and in vivo in porcine been proposed as an alternative therapeutic strategy, with
models. The bench-top studies showed an appropriate frequency potential to revert dysrhythmias to control symptoms [2].
response for analog conditioning and digitization resolution to As in cardiac electrophysiology, implantable pulse
acquire gastric slow waves. The system was able to deliver generators (IPGs) have been used for stimulating the stomach.
electrical pulses at amplitudes up to 10 mA to a load smaller than
Conventionally, two types of pulses have been applied for
880 Ω. Simultaneous acquisition of the slow waves from all three
channels was demonstrated in vivo. The system was able to potential therapeutic effects: short pulses (high frequency/low
modulate –by either suppressing or entraining– the slow wave energy) and long pulses (low frequency/high energy) [3].
activity. This study reports the first high-energy stimulator that Low-energy stimulation is typically delivered with a pulse-
can be controlled wirelessly and integrated into a gastric width in the order of a few hundred microseconds, at
bioelectrical activity monitoring system. The system can be used frequencies ranging from 5 to 100 Hz, and may improve
for treating functional gastrointestinal disorders.
symptoms such as nausea, vomiting, and bloating [4, 5]. High-
energy stimulation (or pacing) is typically delivered with a
Index Terms—Gastric electrical activity, wireless monitoring,
gastric entrainment pulse-width in the order of milliseconds (10-600 ms), at
frequencies akin to the natural gastric frequency (i.e., 3 cpm).
High-energy stimulation has demonstrated potential to pace
slow waves and improve motility [6].
This paper was submitted for review on Sept. 28, 2017. This work was Conventionally, GES is delivered and adjusted through trial
supported in part by the National Institutes of Health SPARC program under and error, without active monitoring of gastric slow wave
Grant NIBIB-U18EB021789, in part by National Institutes of Health Grant
R01 DK64775, in part by the Health Research Council of New Zealand, and responses. It is partly for this reason that conflicting results
in part by the New York Institute of Technology through the Institutional have been reported by various researchers and the role of
Support for Research and Creativity (ISRC) Grant. GES, although investigated for over 50 years, remains
R. Wang, Z. Abukhalaf, A. Javan-Khoshkholgh and *A. Farajidavar
(corresponding author phone: 516-686-4014; fax: 516-686-7439; e-mail:
controversial. A novel method called synchronized GES that
afarajid@nyit.edu) are with the Integrated Medical Systems (IMS) Laboratory includes slow wave data acquisition as an indicator for the
at the School of Engineering and Computing Sciences, New York Institute of efficacy of GES has been proposed in literature [6-8]. Results
Technology, Old Westbury, NY 11568, USA.
S. Sathar, P. Du, T. R. Angeli, G. O’Grady, L. K. Cheng and N.
of using synchronized GES on canine models of postprandial
Paskaranandavadivel are with Auckland Bioengineering Institute, University antral hypomotility significantly increased the amplitude of
of Auckland, New Zealand. T. H.-H. Wang is with the Department of Surgery, gastric contractions and enhanced gastric motility [9].
University of Auckland, New Zealand. G. O’Grady and N. However, the use of this method was limited by the large size
Paskaranandavadivel are also with the Department of Surgery, University of
Auckland, New Zealand. L. K. Cheng is also with the Department of Surgery, of the recording and stimulating systems, and the fact that they
Vanderbilt University, Nashville, TN, USA.
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This article has been accepted for publication in a future issue of this journal, but has not been fully edited. Content may change prior to final publication. Citation information: DOI 10.1109/JETCAS.2018.2812105, IEEE Journal
on Emerging and Selected Topics in Circuits and Systems
JETCAS-2017-0102 2
μC Radio
Programmable
Current Source
Radio
Rec/Stim
GUI
uC
Fig. 1. The block diagram of the system displays the front-end, back-end, Fig. 2. The analog conditioning circuitry for recording gastric slow waves
and a computer which includes the graphic user interface. The system can is shown. This circuit amplifies the signals in two stages, and applies a
record gastric slow waves from three channels and stimulate the stomach band pass filter (0.016-1.6 Hz).
through one channel.
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This article has been accepted for publication in a future issue of this journal, but has not been fully edited. Content may change prior to final publication. Citation information: DOI 10.1109/JETCAS.2018.2812105, IEEE Journal
on Emerging and Selected Topics in Circuits and Systems
JETCAS-2017-0102 3
4.7 µF
2 MΩ
1 µF
2) Back-end unit: Upon powering up the back-end unit, it
initializes clocks, UART, interrupts, and radio (into receiving
20 KΩ
280 KΩ
20 Ω
mode). The back-end receives and processes the packets from
the front-end unit, and sends them to the computer through the
UART communication, until it receives a packet with the “set”
switching role flag byte. At this moment, the back-end
Fig. 3. The stimulation circuitry to deliver electrical pulses is shown. The
DC-DC converter (LTC3549) boosts the input voltage to 10 V level;
switches to the transmission mode, and if there is a stimulation
hence, the voltage controlled current source (LT3092) can deliver 10 mA command —sent from the computer— in its buffer, it builds a
current pulses to a load less than 880 Ω. stimulation packet, clears that command from the buffer, and
transmits the command to the front-end unit. If there is no
B. Simulation Module stimulation command in the buffer, the back-end builds a pass
The front-end can deliver monophasic electrical stimulation command packet and transmits it to the front-end, which
pulses to the stomach through one channel. Fig. 3 shows the translates into “do nothing”. After the transmission of these
analog circuitry necessary to convert the voltage pulse
commands generated by the microcontroller into monophasic Initialize Clocks,
current pulses deliverable to the stomach. A boost converter Radio (TX), ADC,
GPIO, Interrupts,
(LTC3459, by Linear Technology) converts the input voltage Timers
level of 3.3-5 V to up to 10 V in the output. The ratio of the
R1 and R2, and L1 are the major determinants for the output Recording mode
voltage of the boost converter. The 10 V pulse is delivered to a
programmable current source (LT3092, by Linear
No TX Packet
Technology) that delivers current pulses with amplitudes of up Counter ==
to 10 mA. The output current depends on the ratio of R3 and 499 ?
R4, and is limited by the load impedance. The pulse width, Yes
frequency, and on-off periods can be tuned through the GUI,
Pkt.SwitchRole = 1
which is explained later.
C. Firmware Transmit the 500th pkt
wireless packet, and will be sent to the back-end. Each packet Validate and Process
Packet
is composed of 4 bytes for header and 6 bytes of data (2 bytes No Time out
received?
per channel for 3 channels), so the total packet length is 10
bytes. The radio controller automatically adds preamble, Any Yes Yes
address bytes, and cyclic redundancy check bytes to the Stimulation
Cmds ?
packet. The frequency of the wireless communication is tuned Setup stimulation
No timers
at 433 MHz. A counter keeps the record of the sent packets.
The 500th packet, in which the switching role flag is set,
Perform
causes the back-end unit to turn into the transmitting mode. Stimulation
The front-end unit turns into the receiving mode, and sets a
timer. Transmission of 500 packets is equal to 5.55 s of data. Switch To TX
During the receiving mode, which takes 50 ms, the front-end
looks for a stimulation packet transmitted from the back-end.
If a packet is received, the front-end processes it, extracts the
stimulation commands, including on-time (pulse width), off- Fig. 4. The flow chart shows how the front-end module works in the
time, and number of repetitions. The received payload recording mode (transmitting 500 packets), switches to the stimulation
includes the packet length (1 byte), command type (1 byte), mode (receiving stimulation instructions) and restarts the loop.
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This article has been accepted for publication in a future issue of this journal, but has not been fully edited. Content may change prior to final publication. Citation information: DOI 10.1109/JETCAS.2018.2812105, IEEE Journal
on Emerging and Selected Topics in Circuits and Systems
JETCAS-2017-0102 4
13 mm
repetition to occur continuously for an infinite number of
times.
Initialize Clocks,
Fig. 6. The fabricated front-end unit showing the components on (a) top
Radio (RX),
and (b) bottom sides.
UART, Interrupts
2156-3357 (c) 2018 IEEE. Personal use is permitted, but republication/redistribution requires IEEE permission. See http://www.ieee.org/publications_standards/publications/rights/index.html for more information.
This article has been accepted for publication in a future issue of this journal, but has not been fully edited. Content may change prior to final publication. Citation information: DOI 10.1109/JETCAS.2018.2812105, IEEE Journal
on Emerging and Selected Topics in Circuits and Systems
JETCAS-2017-0102 5
Amplitude (mV)
curved due to the capacitive property of the impedance that is 1
typical in stimulation of the excitable tissue [21]. An example 0.5
0
of the measurements for this experiment is available in our -0.5
previous publication [22]. -1
0 0.5 1 1.5 Time (s) 2.5 3 3.5 4
B. Power Consumption of the Front-end Unit in Different
Modes
Amplitude (mV)
1
The power consumption of the front-end was characterized 0.5
0
in data transmitting and stimulation modes. The front-end -0.5
module consumed 68.4 mW and 216 mW while it was in -1
0 0.5 1 1.5 Time (s) 2.5 3 3.5 4
recording and stimulating modes, respectively. The power
consumption during the stimulation mode was measured in the
Amplitude (mV)
worst case scenario when the device was delivering pulses at 1
0.5
10 mA. The power consumption temporary rose to 216 mW 0
during the stimulation and lasted for the period of the pulse. -0.5
-1
Considering a Li-polymer battery that is 260 mAh, and is 0 0.5 1 1.5 Time (s) 2.5 3 3.5 4
approximately the size of the implant (12 mm × 40 mm × 6.4
mm), the front-end can continuously acquire slow waves and
Fig. 8. Signals with different waveforms were generated and streamed to
transmit them wirelessly to the back-end for more than the system to investigate any possible cross-talk.
fourteen hours. During the stimulation mode (without any
recording), considering the stimulation pulses with 500 ms
validated flexible printed arrays [25], placed as a high-density
pulse width that are applied every 20 seconds (translating to 3
grid (256 electrodes in a 16 × 16 array, with 0.3 mm gold
cpm), the front-end can continuously operate for more than
contacts at 4 mm spacing (FlexiMap, New Zealand). Three of
170 hours. these electrodes were connected to the acquisition channels of
C. Recording and Simulation Validation in Animal the novel device; the remainder were connected to an
Experiments ActiveTwo acquisition system (BioSemi, The Netherlands).
In-vivo validation studies were performed in an established To validate the signal acquisition capability of the developed
weaner pig model of gastric dysrhythmia [23], under approval system, the stimulation electrodes were connected to a
from the University of Auckland Animal Ethics Committee. conventional electrical stimulation device (DS8000, World
Full details of our animal preparation are provided elsewhere Precision Instruments, Saratosa, FL). Data analysis was
[24]; in brief, fasted animals (n=5) were subject to general performed off line, in MATLAB (Mathworks, Natick, MA),
anesthesia with Zoletil and isoflurane, followed by midline and using the Gastric Electrical Mapping Suite (GEMS v1.6,
laparotomy under continuous physiological monitoring. FlexiMap, New Zealand) [26], including slow wave event
Stimulation electrodes were implanted at the greater detection, cycle clustering, activation mapping, and
curvature of the proximal gastric corpus and connected to the calculations of frequency, velocity and amplitude.
stimulator (either conventional or the developed system). To 1) Recording: Recording of gastric slow waves was
validate the GES capability of the novel system, the stimulator conducted successfully on two (out of 5) animals. The
electrode was connected to the front-end unit of the developed remaining three animals were not studied because we had
system, and slow wave responses were acquired using already demonstrated recordings from the stomach in our
previous publications [12, 13]. One minute of recording
5 gastric electrical activity is shown in Fig. 9. In this experiment
the three channels were located circumferentially on the
0
Relative gain (dB)
2156-3357 (c) 2018 IEEE. Personal use is permitted, but republication/redistribution requires IEEE permission. See http://www.ieee.org/publications_standards/publications/rights/index.html for more information.
This article has been accepted for publication in a future issue of this journal, but has not been fully edited. Content may change prior to final publication. Citation information: DOI 10.1109/JETCAS.2018.2812105, IEEE Journal
on Emerging and Selected Topics in Circuits and Systems
JETCAS-2017-0102 6
2156-3357 (c) 2018 IEEE. Personal use is permitted, but republication/redistribution requires IEEE permission. See http://www.ieee.org/publications_standards/publications/rights/index.html for more information.
This article has been accepted for publication in a future issue of this journal, but has not been fully edited. Content may change prior to final publication. Citation information: DOI 10.1109/JETCAS.2018.2812105, IEEE Journal
on Emerging and Selected Topics in Circuits and Systems
JETCAS-2017-0102 7
Fig. 11. Validation of gastric pacing for modulating bradygastria, by simultaneous HR electrical slow wave mapping. Left: Diagram showing position of the
stimulation leads and HR electrode mapping array for validation. Middle: Electrograms of slow wave activity before and after gastric pacing. Prior to
stimulation, the slow wave frequency was bradygastric (period 30-40s). During simulation at period 20s, the frequency was increased to 3cpm. Right: HR
propagation maps showing antegrade slow wave propagation over the anterior stomach before and after gastric pacing.
2156-3357 (c) 2018 IEEE. Personal use is permitted, but republication/redistribution requires IEEE permission. See http://www.ieee.org/publications_standards/publications/rights/index.html for more information.
This article has been accepted for publication in a future issue of this journal, but has not been fully edited. Content may change prior to final publication. Citation information: DOI 10.1109/JETCAS.2018.2812105, IEEE Journal
on Emerging and Selected Topics in Circuits and Systems
JETCAS-2017-0102 8
into muscle fatigue if applied for an extended period [21, 27]. stimulation,” Am J Physiol Gastrointest Liver Physiol., vol. 285, no. 3,
pp. 577–585, Sep. 2003.
Further improvements to the system will include the ability to [8] E. Jalilian, D. Onen, E. Neshev, M. P. Mintchev, “Implantable neural
deliver biphasic pulses. electrical stimulator for external control of gastrointestinal motility,”
The front-end is designed in rectangular shape with a width Med. Eng. Phys., vol. 29, no. 2, pp. 238–252, May 2006.
[9] H. Zhu, H. Sallam, D. D. Chen, J. D. Chen, “Therapeutic potential of
of 13 mm for possible endoscopic implantation in the future.
synchronized gastric electrical stimulation for gastroparesis: enhanced
We have already demonstrated such procedures in our gastric motility in dogs,” Am J Physiol Regul Integr Comp Physiol., vol.
previous work [28]. In the future, we will add wireless power 293, no. 5, pp. 1875–1881, Sep. 2007.
transfer capability to the system, and encapsulate the front-end [10] S. H. Woo, J. H. Cho, “Telemetry system for slow wave measurement
from the small bowel,” Med. Biol. Eng. Comput., vol. 48, no. 3, pp. 277–
module with a biocompatible material for long-term studies. 283, Mar. 2010.
Furthermore, to improve the system for better clinical practice, [11] S. Haddab, M. Laghrouche, “Microcontroller-based system for
we will consider running the GUI on a miniature handheld electrogastrography monitoring through wireless transmission,”
Measurement Science Review, vol. 9, no. 5, pp. 122–126, Nov. 2009.
device in lieu of the computer in the back-end. The integration [12] A. Farajidavar, G. O'Grady, S. M. Rao, L. K. Cheng, T. Abell, J. C.
of the recording and stimulation modules takes us one step Chiao, “A Miniature Bidirectional Telemetry System for in-vivo Gastric
closer to realization of a fully-functional closed-loop system Slow Wave Recordings”, Physiol Meas., vol. 33, no. 6, pp. N29–N37,
Jun. 2012.
for treating gastric disorders. To that end, criteria to [13] N. Paskaranandavadivel, R. Wang, S. Sathar, G. O’Grady, LK Cheng, A
automatically detect abnormal slow wave activity and Farajidavar, “A wireless multichannel system for in-vivo monitoring of
optimize stimulation parameters need to be further explored. gastric activity propagation”, Neurogastroenterol Motil., vol. 27, no. 4,
pp. 580–585, Apr. 2015.
[14] A. Ibrahim, A. Farajidavar, M. Kiani, “Towards a Highly-Scalable
V. CONCLUSION Wireless System-on-Chip for Gastric Electrophysiology”, Conf Proc
IEEE Eng Med Biol Soc (EMBS), vol. 1, pp. 2689–2692, Aug. 2015.
A novel miniature system that can wirelessly record gastric [15] A. Javan-Khoshkholgh, Z. Abukhalaf, J. Li, L.S. Miller, M. Kiani, A.
electrical activity from three channels and deliver high-energy Farajidavar, “An Inductive Narrow-Pulse RFID Telemetry System for
electrical pulses to the stomach was developed and validated Gastric Slow Waves Monitoring”, Conf Proc IEEE Eng Med Biol Soc
on bench-top and animal experiments. It was demonstrated (EMBS), vol. 1, pp. 4820–4823, Aug. 2016.
[16] A. Ibrahim, A. Farajidavar, M. Kiani, “A 64-Channel Wireless
that the system can successfully modulate gastric slow waves. Implantable System-on-Chip for Gastric Electrical-Wave Recording”,
To our knowledge this is the first time a high-energy Conf Proc IEEE Sensors, vol. 1, pp. 1–3, Oct. 2016.
stimulator that can be controlled wirelessly has been [17] A. Farajidavar, C. E. Hagains, Y. B. Peng, K. Behbehani, J.-C. Chiao,
“Recognition and Inhibition of Dorsal Horn Nociceptive Signals within
developed and integrated into a gastric bioelectrical activity a Closed-loop System”, Conf Proc IEEE Eng Med Biol Soc (EMBS),
monitoring system. vol.1, pp.1535–1538, Sept. 2010.
[18] A. Farajidavar, C. E. Hagains, Y. B. Peng, J.-C. Chiao, “A Closed Loop
Feedback System for Automatic Detection and Inhibition of Mechano-
ACKNOWLEDGEMENTS nociceptive Neural Activity”, IEEE Trans. Neural Syst. Rehabil. Eng.,
We thank Linley Nisbet for her expert technical assistance. vol. 20, no. 4, pp. 478–487, Jul. 2012.
[19] A. J. Arriagada, A. S. Jurkov, E. Neshev, G. Muench, C. N. Andrews,
SS, PD, TRA, GO, LKC and NP are shareholders in M. P. Mintchev, “Design, implementation and testing of an implantable
FlexiMap and/or hold intellectual property in the field of impedance-based feedback-controlled neural gastric stimulator,”
gastric electrophysiology. No commercial or industry financial Physiol. Meas., vol. 32, no. 8, pp. 1103-1115, Aug. 2011.
[20] A. Farajidavar, P. G. McCorkle, T. W. Wiggins, S. R. M. Rao, C. E.
support was provided for this study. Hagains, Y. B. Peng, J. L. Seifert, M. I. Romero, G. O'Grady, L. K.
Cheng, S. Sparagana, M. R. Delgado, S. Tang, T. Abell, J.-C. Chiao, "A
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2156-3357 (c) 2018 IEEE. Personal use is permitted, but republication/redistribution requires IEEE permission. See http://www.ieee.org/publications_standards/publications/rights/index.html for more information.
This article has been accepted for publication in a future issue of this journal, but has not been fully edited. Content may change prior to final publication. Citation information: DOI 10.1109/JETCAS.2018.2812105, IEEE Journal
on Emerging and Selected Topics in Circuits and Systems
JETCAS-2017-0102 9
[27] E. Soffer, T. Abell, Z. Lin, A. Lorincz, R. McCallum, H. Parkman, S. Timothy R. Angeli received a BSE (Magna Cum
Policker, T. Ordog, “Review article: gastric electrical stimulation for Laude) and MSE in Biomedical Engineering from the
gastroparesis – physiological foundations, technical aspects and clinical University of Michigan in 2008 and 2009,
implications,” Aliment Pharmacol Ther, vol. 30, no. 7, pp. 681–694, Jul. respectively. He received a PhD in Bioengineering
2009. from the University of Auckland in 2014. Timothy is
[28] A. Vegesna, L. S. Miller, M. Alshelleh, A. Farajidavar, “Endoscopic currently a Senior Research Fellow at the Auckland
Method for Device Implantation into the Gastrointestinal tract”, Bioengineering Institute, University of Auckland.
Gastrointest Endosc., vol. 85, no. 5, Supplement, pp. AB502, May 2017.
Rui Wang received the B.Sc. degree in Control Leo K. Cheng received a BE (Hons) in Engineering
Engineering in 2013 from Beijing Jiaotong University, Science and a PhD in Bioengineering from the
China. He received the M.Sc. degree in Electrical and University of Auckland in 1997 and 2002,
Computer Engineering in 2015 from New York respectively. He is currently a Professor at the
Institute of Technology, United States of America. His Auckland Bioengineering Institute, University of
research interests are embedded systems design and Auckland.,
wireless communication with applications in medical
devices.
Greg O’Grady (MBChB, PhD, FRACS) is an
Zaid Abukhalaf received his B.Sc. degree in Computer Associate Professor of Surgery at the University of
Engineering in 2013 from Hashemite University, Auckland, New Zealand. He leads the Surgical
Jordan. He earned his M.Sc. degree in Electrical and Engineering Lab, and practices clinically as a
Computer Engineering in 2016 from New York gastrointestinal surgeon
Institute of Technology. His research focus is high-
performance and low-power hardware accelerators and
digital systems. Zaid currently works in the embedded
systems industry implementing low-level software and
systems architectures. Niranchan Paskaranandavadivel received a BE in
Biomedical Engineering and ME (Hons) and PhD in
Amir Javan-Khoshkholgh received the M.Sc. and Bioengineering at the University of Auckland in
Ph.D. degrees in Electronics engineering from the 2007, 2009 and 2014 respectively. He is a Research
Polytechnic University of Turin, Italy, in 2011 and Fellow at the Auckland Bioengineering Institute at
2015, respectively. He is currently a Postdoctoral the University of Auckland.
Researcher at the Integrated Medical Systems
Laboratory and Adjunct Assistant Professor in the
Electrical and Computer Engineering department at
New York Institute of Technology (NYIT). Before Aydin Farajidavar (S’09-M’12) received the B.Sc.
joining NYIT, he was a Research Scholar at the Microwave Microsystems and M.Sc. degrees in biomedical engineering, in 2004
Laboratory at the University of California, Davis. and 2007, respectively. He received the Ph.D. degree
His research interests are low-power analog / mixed-signal / digital circuit in biomedical engineering from the joint program of
design for wireless and RF applications and wireless power transfer for the University of Texas at Arlington and the
biomedical systems and implantable devices. University of Texas Southwestern Medical Center,
Dallas in 2011. He is currently an Assistant Professor
Tim Wang received a Bachelor of Medicine and of Electrical and Computer Engineering and the
Bachelor of Surgery (MBChB) at the University of Director of Integrated Medical Systems Laboratory at New York Institute of
Auckland in 2016. He is a current surgical registrar at Technology (NYIT). Before joining NYIT, he was a Post-doctoral Fellow in
Auckland City Hospital and is also completing a PhD the School of Electrical and Computer Engineering at the Georgia Institute of
in Surgery at the University of Auckland. Technology.
His research experience and interests cover a broad range, from Medical
Cyber Physical Systems (implantable, wearable and assistive technology) to
modeling biological systems. Dr. Farajidavar has authored more than 50 peer-
reviewed journal and conference papers/abstracts. He has served as technical
committee member for several international IEEE conferences. He serves as a
Shameer Sathar received a bachelor’s degree (B.Tech) member of MTT-10, Biological Effect and Medical Applications of RF and
with first class (Distinction) from Cochin University Microwave committee.
of Science and Technology, India in 2010 and
received a PhD in Bioengineering from the University
of Auckland in 2015. He is currently a Research
Fellow at the Auckland Bioengineering Institute,
University of Auckland.
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