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B. Braun Interventional Systems and Infraredx Announce Strategic U.S. Collaboration to Execute the IDE Clinical Trial for the SeQuent® Please ReX™ Drug Coated PTCA Balloon Catheter

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March 31, 2021

B. Braun Interventional Systems Inc. announced today that they will collaborate with Infraredx, a Nipro company, to accelerate FDA Investigational Device Exemption (IDE) clinical trial for the B. Braun SeQuent® Please ReX™ Drug Coated PTCA Balloon Catheter, which received FDA Breakthrough Device Designation in late 2019.

This announcement furthers the long-term global cooperation between the B. Braun Group of Companies and Japan-based Nipro Corporation to advance coronary artery disease management.

The companies are ideally positioned to leverage shared resources to accelerate the initiation of the U.S. clinical trial of the SeQuent Please ReX to study the treatment of coronary in-stent restenosis (ISR), which is defined as the gradual re-narrowing of a coronary artery following stent implantation. Despite a significant reduction in ISR when using a drug-eluting stent (DES), a recent study has shown that ISR represents approximately 10% of all percutaneous coronary interventions in the U.S.1

With a shared interest in the study, BIS and Infraredx will pool clinical expertise and financial resources to execute the U.S. study.

“B. Braun and Nipro have worked together over the last decade to arm vascular specialists in Europe and Asia with alternative therapies for coronary interventions,” said Nozomu Fujita, President & CEO of Infraredx, a Nipro Company. “Our decision to also align the resources of our U.S. entities will accelerate how quickly U.S. Interventionalists will be able to access the SeQuent Please ReX technology for U.S. clinical trials.”

Outside of the U.S., B. Braun has successfully sold more than one million SeQuent Please Drug Coated PTCA Balloon Catheters. The SeQuent Please ReX, a variation to the current SeQuent Please portfolio sold outside the United States, was developed exclusively for the U.S. market, and represents the most recent development in the B. Braun DCB portfolio.

“Over the last decade, together with Nipro, we have been able to develop the market for coronary drug-coated balloons by delivering high-quality clinical evidence and optimal physician and patient access,” said Dr. Philip Steen, Director of Medical, Scientific & Regulatory Affairs, B. Braun Melsungen AG Vascular Systems. “Aligning with Infraredx to work toward bringing the SeQuent Please Technology to the U.S. marketplace through the U.S. IDE process is a logical next step to address an important unmet clinical need.” Dr. Steen, an Interventional Cardiologist by training, had used the SeQuent Please portfolio to treat patients in Germany prior to joining B. Braun Melsungen AG Vascular Systems as a senior leader and strategic clinical advisor to the organization.

The SeQuent Please drug-coated balloons for the treatment of coronary artery disease is supported by significant clinical data. The clinical evidence is underlined in more than 19 randomized controlled trials.2

The B. Braun Group of Companies is the worldwide market leader in drug-coated PTCA technology. BIS received FDA Breakthrough Designation for the SeQuent Please ReX in 2019.

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GE Healthcare Expands Ultrasound Family with Venue Fit

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March 30, 2021

GE Healthcare today unveiled Venue Fit ™, a streamlined and compact POCUS system, alongside an industry-first AI offering for cardiac imaging on the Venue™ and Venue Go™.

The Venue Fit is the smallest system in GE Healthcare’s Venue Family, featuring an easy-to-clean touchscreen, intuitive scanning tools, and a small footprint designed to fit in tight spaces often found in point-of-care settings.

The Venue Fit and associated AI come at a time where clinicians are relying on point of care ultrasound to combat the more than 127 million COVID-19 cases worldwide.1 Offering portability, real-time images, cleanability and workflow efficiency, POCUS has become an essential tool enabling clinicians to quickly triage and monitor patients in and outside of COVID wards. Accordingly, GE Healthcare saw orders for its existing Venue Go system increase more than fivefold in 2020 compared to the year prior.2

“COVID-19 has had a huge impact on my practice as we’re currently seeing a surge in the emergency department, and I’ve been taking my Venue Go with me everywhere I go,” said Dr. Joseph Minardi, Chief of the Division of Emergency and Clinical Ultrasound and Director of the Center for Point-of-Care Ultrasound at a West Virginia academic medical center. “With the new Venue tools, I don’t have to struggle with the interface to be efficient. I can bring the device in with me, scan the patient, and using the Lung Sweep and RealTime EF (ejection fraction), I have the information I need right away.”

The new Venue Fit ultrasound system helps meet the needs of providers in tight spaces needing quick imaging insights. It’s smaller in size, but still provides the same Venue Family image quality, touchscreen, intuitive interface, and real-time documentation software that can save time and boost clinical confidence.

In addition to the release of the Venue Fit, the existing Venue Go and Venue ultrasound systems will now offer an industry-first AI tool for cardiac scanning with an integrated quality indicator, RealTime EF, alongside new software applications:

  • RealTime EF, the industry’s first AI tool that continuously calculates the heart’s real-time ejection fraction, a measurement of the heart’s ability to pump blood effectively, during live scanning with an integrated quality indicator that helps users know when they have an adequate view to generate accurate measurements of this critical cardiac measurement. The tool can help reduce the need for ECGs and support clinical confidence.
  • Lung Sweep, a rapid visualization tool that provides a dynamic panoramic view of the entire lung. This tool automatically activates at the start of each sweep when the probe is tapped on the body and deactivates at the end of each sweep when the probe is lifted, so there’s no need to touch the screen. The Auto B-lines tool can be used in conjunction with Lung Sweep to highlight B-lines over the entire panoramic view and display the frame with the most B-lines per rib space.
  • Renal Diagram, a simplified, intelligent documentation tool that allows clinicians to select labels from a prepopulated list that correlates with the images captured, making it easy for other clinicians to follow up on patients with suspected kidney infection.

“This past year we’ve seen point of care ultrasound take a prominent place at the bedside for clinicians, driven by its intuitive design and AI-powered diagnostic prowess,” said Dietmar Seifriedsberger, general manager of Point of Care Ultrasound at GE Healthcare. “Understanding healthcare’s growing resource constraints and the challenges of today’s world, we’re expanding our Venue Family and offerings to help improve our customer’s workflow efficiency and diagnostic confidence.”

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Smiths Medical Announces the ECRI Evaluation of the CADD®-Solis v4 Wireless Ambulatory Infusion System

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March 30, 2021

Smiths Medical is a leading medical device manufacturer. Today they announced the release of the ECRI evaluation report for CADD®-Solis v4 with wireless communication Patient-Controlled Analgesic (PCA) and epidural infusion pump.

ECRI is an independent non-profit organization improving the safety, quality, and cost-effectiveness of care across all healthcare settings worldwide. The report highlights ECRI’s evaluation ratings, test results, and purchasing recommendations for the CADD®-Solis pump.

The CADD®-Solis v4 system is a continuation of Smiths Medical’s commitment to advance patient care and help improve patient outcomes through leading-edge technology.

The CADD®-Solis pump maintains the advantages of an ambulatory pump for patient mobility and provides a single system that effectively delivers IV PCA, epidural, peripheral nerve blocks and subcutaneous from pump to patient. For the hospital, the CADD®-Solis system is designed to enhance patient safety through “smart programming” (use of medication safety software) and reduce the risk of tubing misconnections while providing a comprehensive and intuitive user experience for the healthcare provider.

“Smiths Medical is committed to patient safety and adoption of smart infusion pumps,” said Nathan Walker, Director of Ambulatory Infusion at Smiths Medical. “The wireless bi-directional communication sets the foundation for integrating pain management data delivery directly into the patient records in the hospital’s Electronic Health Records (EHR auto-documentation), saving clinicians time charting and increasing documentation accuracy.”

For more information about the CADD®-Solis PCA and epidural pump and to request a copy of the report visit here.

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SteadyMD Raises $25 Million Series B Capital: Lux Capital Led the Round

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March 30, 2021

SteadyMD, a technology company and healthcare provider that delivers high-quality telehealth experiences in all 50 states, today announced a $25 million Series B capital raise to enhance the company’s platform services that now power the telehealth infrastructure of digital health businesses and employers.

Lux Capital led the round, with Partner Deena Shakir joining the SteadyMD Board of Directors and additional participation from Ashton Kutcher and Guy Oseary’s Sound Ventures, Acrew Capital, and other healthcare investors. The new capital comes after five years of strong growth within SteadyMD’s proven direct-to-consumer primary care offering and will support the recent expansion of its platform services, which enable telehealth providers across the care continuum to scale with a 50-state clinician workforce, legal and regulatory guidance, and supporting technology.

Founders Guy Friedman and Yarone Goren launched SteadyMD as a direct-to-consumer telehealth company in 2016, offering individuals and families unlimited, direct access to a primary care physician uniquely matched to their health and lifestyle. Since its Series A round in early 2020, led by Pelion Venture Partners and NEXT VENTŪRES, SteadyMD has capitalized on the technology and clinicians behind the success of its consumer business in order to help digital health companies and employers do the same for their patients and employees across all 50 states. SteadyMD currently works with leading employers and online-first companies delivering primary care, behavioral health, digital pharmacy, medical device, at-home lab, and other telehealth services.

“We launched SteadyMD to deliver the highest quality of care possible to patients nationwide, completely online,” said Guy Friedman, SteadyMD Co-founder & CEO. “We’ve solved the puzzle of delivering that care in all 50 states, which involves numerous product, technology, legal, clinical, and operational challenges. Today, leading healthcare organizations rely on SteadyMD for the key infrastructure to launch, scale, and grow their telehealth offerings in the massive and quickly expanding digital health market.”

“Our success on the front lines now enables us to work behind the scenes for companies with like-minded missions to design quality telehealth solutions,” said Yarone Goren, SteadyMD Co-founder & COO. “Between clinician management and staffing, predicting patient demand, patient-provider matching, legal and regulatory issues, and the technology infrastructure that goes into a best-in-class telehealth operation, we’re helping companies deliver the highest quality healthcare where patients are — online.”

In addition to Lux Capital, Sound Ventures, and Acrew Capital, several prominent healthcare executives and investment leaders participated in the Series B round, including Anne Wojcicki (co-founder of 23andMe) and Draper Associates.

“I have witnessed the transformation of virtual care over the last decade — as an operator and now as an investor — and I could not be more excited about the potential of telehealth to transform how care is delivered, research is conducted, and ultimately how health equity and health justice are achieved. The industry has only begun to scratch the surface, and the pressures of the pandemic have propelled telehealth into permanence,” said Deena Shakir, Partner at Lux Capital, who now joins SteadyMD’s board. “Guy and Yarone are exactly the type of founders we take pride in backing — mission-driven, execution-oriented, ambitious, and gritty. We are proud to be joining them on this journey to improve human health through technology.”

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Dr. Timothy Deer joins PainTEQ Scientific Advisory Board

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March 40, 2021

Dr. Timothy Deer, MD, DABPM is president and CEO of The Spine & Nerve Centers in Charleston, West Virginia.

PainTEQ is the creator of LinQ (pronounced “link”), a minimally invasive therapy for sacroiliac (SI) joint dysfunction.

With extensive experience in interventional pain management and a clinical professor of anesthesiology at West Virginia University, Deer brings both clinical and institutional knowledge of pain management. Dr. Timothy Deer is president emeritus of the West Virginia Society of Interventional Pain Physicians (WVSIPP) and past president of the International Neuromodulation Society (INS). Dr. Deer is also a former member of the board of directors of the American Society of Interventional Pain Physicians (ASIPP).

“PainTEQ’s LinQ system has changed the way we treat SI joint dysfunction. This posterior approach is the safest, and I’ve seen many suffering patients experience relief immediately,” said Dr. Timothy Deer. “I’m thrilled to work alongside a group of innovators to help make LinQ more accessible across the country and help launch a comprehensive medical education program to train physicians with LinQ.”

Dr. Deer is known for extensive research published in scientific journals and online resources with topics ranging from minimally invasive disc procedures to spinal cord and peripheral nerve stimulation. Dr. Deer also works to educate government officials on safe use of pain therapies and expanding access to care.

“Dr. Deer’s expansive knowledge and understanding of unique conditions and approaches make him an ideal fit for the Scientific Advisory Board,” said PainTEQ CEO, Sean LaNeve. “We continue to realize our goal of bringing the best-of-the-best onto the PainTEQ team.”

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BIOLASE Announces a Pilot program with Einstein Healthcare Network’s Residency in Endodontic

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March 30, 2021

BIOLASE notes the goal of the program is to offer residents hands-on experience with dental lasers that are already in use across the industry, allowing residents to immediately implement their training when joining a future practice.

“BIOLASE has a deep commitment to the endodontic specialty,” said John Beaver, President and CEO of BIOLASE. “It is important for us to live out our mission of advancing dentistry by empowering the next generation of endodontists from Einstein. We are honored to be part of not only the residents’ future careers by arming them with innovative technologies, but also the future relationships they will build with their patients by offering a less invasive and more positive experience.”

Einstein Healthcare Network’s residency in endodontics is one of the first hospital-based endodontic programs approved by the American Dental Association. The residency is a 24-month program that admits two residents each year, preparing graduates to practice, teach and conduct independent research.

“We are committed to actively seeking out ways to help our residents feel fully equipped to enter into endodontic practice after leaving our program,” said Frederic Barnett, DMD, Chairman of the Department of Dental Medicine, and Chair and Program Director of Postdoctoral Endodontics at Albert Einstein Medical Center in Philadelphia. “Partnering with BIOLASE to integrate laser assisted endodontic training early on in our residents’ careers allows us to tighten the learning curve, which can positively impact a practice’s bottom line and ultimately provide a better patient experience overall.”

The Waterlase dental laser offers various benefits for endodontists, from faster procedures to new treatment options. Educating endodontists about the benefits of dental lasers is part of BIOLASE’s continued effort to help improve patient experiences and outcomes. This announcement comes on the heels of the recently developed Waterlase Endo Academy, open to all Waterlase endodontists. Learn more about the benefits of laser dentistry in endodontics at biolase.com/betterendo.

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Eric Hargan Joins Alio Board of Directors

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March 30, 2021

Eric Hargan will join the Alio Board of Directors as an Observer effective March 2021.

Alio has achieved a number of important milestones in the last several months, culminating in Hargan’s addition to the board.

Eric Hargan brings 25 years of legal and healthcare expertise and is nationally recognized for his former role as United States Deputy Secretary of Health and Human Services (HHS) from October 2017 to January 2021.  He has played an instrumental role in driving innovation in the dialysis market, from realigning incentives to enable value-based arrangements between providers and digital health companies to enabling the availability of more breakthrough devices.

Hargan was also critical to the creation of The Kidney Innovation Accelerator (KidneyX), a public-private partnership between the U.S. Department of Health and Human Services and the American Society of Nephrology (ASN) to accelerate innovation in the prevention, diagnosis, and treatment of kidney diseases. ASN recognized Hargan’s work on KidneyX and the HHS Kidney Health Initiative with its President’s Medal in 2019.

Prior to his role as US Deputy Security of the HHS, Eric Hargan served in the private sector as a partner at Greenberg Traurig and McDermott Will & Emery. From 2003-2005, he served as Deputy General Counsel of HHS for the George W. Bush administration, eventually serving as Acting Deputy Secretary of HHS. Hargan began his career in corporate law at Winston & Strawn.

“Hargan’s deep expertise in the regulatory process, as well as his passion for innovation, make him an excellent addition to our board,” said David Kuraguntla, Alio’s Co-Founder and CEO. “Working in and around healthcare in a variety of capacities has only reinforced the importance of chronic condition management to Mr. Hargan. He recognizes the value of supporting a patient in better maintaining and monitoring their condition.”

Alio’s technology has been honed and advanced through a number of strategic partnerships, including Intermountain Healthcare. Rather than repurposing off-the-shelf sensors and technology, Alio has created their proprietary technology with the chronic condition community in mind. Each new application has allowed Alio to better understand the reach, scope and scale of what they can accomplish in the remote patient monitoring world. Hargan’s expertise, particularly in remote patient monitoring and forward-thinking reimbursement practices, will be essential in guiding Alio at this critical inflection point.

“Without products like Alio’s SmartPatch, we won’t be able to rethink our approach to managing chronic conditions, particularly for the more vulnerable patient populations,” said Eric Hargan, former Deputy Secretary of Health and Human Services. “We need to do more to deliver the right level of care at the right place and right time. If you look at the way we have approached cancer management, we’ve come so far but comparatively, dialysis care has hardly changed over the last forty years. It’s time we bring to market solutions that reimagine, improve and progress our management of kidney conditions.”

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Embrace Hydrogel Embolic System Global Randomized Multi-Center Clinical Trial: 1st Patients Enrolled

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March 30, 2021

Embrace Hydrogel Embolic System (HES™) is a global randomized clinical trial for the treatment of hypervascular tumors.

As demonstrated previously in the completed First-in-Human (FIH) study, Embrace Hydrogel Embolic System (HES) was effective at embolizing malignant and benign hypervascular tumors by blocking tumor blood supply with complete technical success and persistent embolizationi as noted in imaging follow up at 30-days.

“I am pleased to be evaluating this new technology for hypervascular tumor embolization,” commented Dr. Gerard Goh, Head of Interventional Radiology at The Alfred Hospital, Melbourne Australia, and President of the Interventional Radiology Society of Australasia (IRSA). “While participating in the First-in-Human study prior to this trial, Embrace showed great promise with good control, favorable patient outcomes, and no tumor revascularization. We are excited to be the first center to enroll in this global, randomized trial.”

A hypervascular tumor, which can be found in the liver, kidney, or elsewhere, has an increased number of blood vessels relative to other tissues. These tumors are often associated with low survival rates.ii Due to the increased risk of bleeding, hypervascular tumors can be challenging to remove.

Transcatheter arterial embolization (TAE) and transarterial chemoembolization (cTACE) are established treatments for hypervascular tumors, particularly for patients with limited progressive disease. Embrace HES, an investigational product, is a liquid embolic designed to deeply penetrate the tumor vascular bediii, solidify, and stop blood flow.

The Embrace HES embolization uses no solvents, does not need sizing to the vessel diameter, and eliminates the possibility of catheter entrapment. Its main components are water and polyethylene glycol (PEG). PEG has a long history of safe use in implantable medical devices.

“We are thrilled to be the first center in the US to treat a patient on this study. Embrace’s predictability helps me embolize the tumor while avoiding non-target embolization,” added Dr. Edgar D. St. Amour, Interventional Radiologist from CARTI Cancer Center in Little Rock. “I look forward to continued evaluation of this new advancement in treating hypervascular tumors.”

“I would like to thank Drs. Goh and St. Amour, and our other global trial sites for their efforts and collaboration in achieving this significant clinical milestone,” said Amar Sawhney, Instylla CEO. “Hypervascular tumors can cause significant morbidity and mortality. At Instylla, we are focused on creating novel solutions to improve outcomes for these patients.”


i Manuscript submitted for publication

ii Hotta, Naoki & Ayada, Minoru & Okumura, Akihiko & Ishikawa, Tetsuya & Sato, Ken & Oohashi, Tomohiko & Hijikata, Yasutaka & Kakumu, Shinichi. (2009). Hepatocellular Carcinoma 11 and a Half Years after the Resolution of Chronic Hepatitis C Virus Infection Successfully Treated with Interferon. Case reports in gastroenterology. 3. 175-181. 10.1159/000225244.

iii Ganguli S, Lareau R, Jarrett T, Soulen MC, A Water-based Liquid Embolic: Evaluation of Safety and Efficacy in a Rabbit Kidney Model, Journal of Vascular and Interventional Radiology (2021)

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American Society for Reproductive Medicine Publishes Validation Study on Embryo Transfer Simulator

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March 29, 2021

American Society for Reproductive Medicine notes each year, millions of American families struggle with infertility. For every 100 couples, 12 to 13 report they’ve experienced troubles getting pregnant, according to the Center for Disease Control and Prevention. And about 7.3m women of childbearing age in the U.S. have used fertility treatments to get pregnant.

The high financial and emotional investment into each IVF cycle means that there is a high expectation for physicians to optimally start that journey towards a live birth.

However, over half of REI fellows perform under 10 live embryo transfers during their 3 years of subspecialty training, and half of those had never performed an embryo transfer. Simulation training is a promising way to increase training opportunities for Reproductive Endocrine and Infertility (REI) education.

Data were collected from 78 REI fellows during an ASRM approved two-day course which allowed fellows to practice upwards of 20 embryo transfers, better equipping them to be confident and competent in the clinical environment.

All fellows on the course demonstrated growth in confidence and procedure technique, whether they had already performed live embryo transfers or had little or no experience.

The highest improvement was for those in their second year of the fellowship who had not previously performed live embryo transfers with a 125% increase in self-confidence. This corresponds to an improvement of 2.48 on a 6-point Likert scale ranging from 1 – not confident, to 6 – expert confidence.

Senior author of the article, Richard H. Reindollar, M.D., notes that “The time of seeing one, do one, teach one is gone. Fellows today need to train on simulators over and over again until they achieve a defined competency level. The Embryo Transfer Certificate Course is essential in both the development and maintenance of embryo transfer skills.”

ASRM requires fellows to reach a cumulative score of over 80% in order to be considered proficient. The simulator also includes different uterine models, for fellows to practice their skills across patient cases of increasing difficulty. From the two-day course, it was demonstrated that only 20% of fellows reached the proficiency level across all four different uterine models on their first attempt, and by the end of the course, all participants reached the objective proficiency benchmark.

President and General Manager of VirtaMed Inc, Craig Neita, says: “As a couple undergoing Fertility Treatment, you’re hoping that any given IVF cycle will be successful.  It is gratifying to have scientific data that shows how simulation may help couples achieve better outcomes through improved competency and training of fertility specialists.”

Justin Grooms, Vice President of Strategic Partnerships, states, “The study authors did great work researching simulation training for embryo transfer in this first published scientific validation study for the ASRM Embryo Transfer simulator. It’s a beacon for the future of reproductive training, and is particularly relevant today as a solution to socially distant training.”

The results of the full program and study have been published in Fertility and Sterility online.

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HOYA Confirms Their 5 Year Contract Announced July 2020 for Technical Collaboration and Supply of Diagnostics Ultrasound Systems and Ultrasound Sensor with Hitachi Becomes Effective March 31st 2021

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March 29 2021

Hoya notes EUS consists of a diagnostic ultrasound system and ultrasound flexible endoscopes and is used for examinations to evaluate the cancer staging in the liver, pancreas, and bronchus.

PENTAX Medical is a division of HOYA Group delivering endo-imaging solutions. Details can be confirmed in the joint press release on July 6, 2020, here.

Hitachi concluded an absorption-type company split agreement regarding the transfer of its diagnostic imaging-related business (CT, MRI, X-ray Systems, Ultrasound, and electronic health records) to FUJIFILM Corporation, and has announced to set the closing date of share transfer, which had not yet been decided, to March 31, 2021, and this agreement will be valid after such transfer.

Certainly, this long-term agreement is not only limited to the cooperation for the next five years but also contains a long-term availability of spare parts beyond the terms of this agreement in order to provide the best service to our customers.

Gerald Bottero, Global President of PENTAX Medical, HOYA Corporation, stated, “We are honored to continue our alliance with Hitachi which began with joint research in 1983 leading to the first commercial launch of our EUS in 1990. The Hitachi ultrasound technology is globally recognized as an important standard in EUS with high-quality imaging, advanced software modalities, and ease of use. We look forward to working with Hitachi’s world-class research teams to accelerate innovation and wide adoption in this vital space.”