- 510(k) Clearance of first-of-kind Endoscopic Ultrasound (EUS) technology
- Paves the way for safer and more accessible medical care
- EndoSound will begin its controlled market release early in Q1 2024
Portland, Jan. 2, 2024—EndoSound Inc., a pioneering medical technology company dedicated to advancing patient care, is pleased to announce it has received 510(k) clearance from the FDA for its EndoSound Vision SystemTM (EVS). This milestone achievement follows the company’s FDA Breakthrough Device designation in July 2021, emphasizing the technology’s safety features and its potential to enhance access to patient care.
The EVS is a novel endoscopic ultrasound (EUS) device that attaches to upper gastrointestinal endoscopes. It easily integrates into any endoscopy center’s existing ecosystem. The EVS is poised to revolutionize the landscape of EUS. With a more economical offering, the EVS can provide greater access to this critical imaging and therapeutic procedure than conventional EUS equipment. EndoSound expects the EVS will shift the site of care to more efficient settings like the ambulatory surgery center (ASC) preferred by patients, providers, and payers.
“We are thrilled to receive 510(k) clearance for our EVS, a testament to the dedication and innovation of the entire EndoSound team. This milestone underscores our commitment to advancing medical technology and improving patient outcomes. With the EVS, we aim to not only enhance the safety of endoscopic procedures but also contribute to expanding access to care for patients worldwide,” said Dr. Stephen Steinberg, President and CEO at EndoSound.
The FDA’s Breakthrough Device designation recognized the EVS for its groundbreaking approach to patient safety, cost reduction, and ability to increase accessibility to critical medical care. The EVS represents a significant leap forward in medical technology, specifically addressing the critical issue of infections associated with difficult-to-clean endoscope elevators. This clearance validates the system’s effectiveness and safety, underscoring EndoSound’s commitment to advancing healthcare through innovation.
Endoscopic Ultrasound Procedure
Endoscopic Ultrasound (EUS) is a minimally invasive procedure performed to assess diseases of the GI tract and other nearby organs and tissues. High-frequency sound waves produce detailed images of the pancreas, liver, and gallbladder. Currently, over 95% of patients who undergo EUS are seen in a hospital setting. A majority of those patients could be seen in a more efficient setting where patients prefer to be treated, an ASC.
EndoSound, Inc., is a privately held company based in Portland, Oregon. EndoSound is dedicated to expanding access to endoscopic ultrasound technology around the world. With its patented design, EndoSound transforms any flexible upper endoscope into a fully functional EUS scope. It is comprised of an experienced team of scientists and engineers, clinicians, and seasoned business professionals with a track record of bringing new medical devices to market.
To learn more about the EVS, please visit endosound.com.
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- EndoSound and AdaptivEndo sign letter of intent to expedite innovation in endoscopy.
- Jointly completed first milestone animal trial including use of the first-ever simultaneous EUS/ERCP device.
- Collaboration will provide even safer options and more accessible solutions for patient and healthcare providers.
PORTLAND, Ore.–(BUSINESS WIRE)–EndoSound, a pioneer in endoscopic ultrasound technology (EUS), and AdaptivEndo, a leader in single-use endoscopy solutions, are proud to announce their letter of intent to collaborate on a new groundbreaking project that aims to transform the landscape of endoscopy. These two innovative companies have come together to expand EndoSound’s novel ultrasound technology into the single-use endoscopy space, thus improving patient safety and increasing access to care.
“The successful in-vivo lab represents a significant leap forward in the field of endoscopy”
The collaboration between EndoSound and AdaptivEndo recently reached a significant milestone with the successful completion of an in-vivo porcine animal lab. During this trial, the teams demonstrated their ability to perform EUS with a single-use AdaptivEndo gastroscope and an AdaptivEndo duodenoscope. This achievement marked a historic moment as the first-ever simultaneous EUS/ERCP procedure using a singular EUS/ERCP device.
EUS is a vital diagnostic and therapeutic tool in gastroenterology. Traditionally, EUS procedures have been performed with reusable endoscopes, which presents challenges related to infection control, sterilization, and access to care. Part of EndoSound’s mission is to make EUS safer and more accessible as exemplified in its elimination of difficult to clean moving parts (elevator) and delivering a product at a fraction of current costs. By integrating EndoSound’s cutting-edge ultrasound technology into single-use endoscopes, this collaboration aims to bring these efforts further and offer an even safer and more accessible solution for patients and healthcare providers.
“The successful in-vivo lab represents a significant leap forward in the field of endoscopy,” said Dr. Steve Steinberg, CEO of EndoSound. “We are thrilled to partner with AdaptivEndo, a company known for its dedication to innovation and patient safety. Together, we envision a future where healthcare professionals can perform EUS procedures confidently and conveniently with single-use equipment, further expanding patient access and ultimately improving outcomes.”
AdaptivEndo’s President, Ed Fancher, shared similar sentiments: “Our collaboration with EndoSound signifies our commitment to pushing the boundaries of endoscopic technology. By combining our expertise in single-use endoscopy with EndoSound’s revolutionary ultrasound technology, we aim to accelerate the time to market for both of our cutting-edge technologies. This partnership will reshape the endoscopy landscape, making advanced procedures more accessible and safer for patients.”
This collaboration is set to transform the field of endoscopy, addressing key challenges and bringing state-of-the-art technologies to healthcare facilities worldwide. With their shared vision of enhancing patient care and safety, EndoSound and AdaptivEndo are poised to make a lasting impact on the gastrointestinal community.
About EndoSound: EndoSound, Inc., is a privately held company based in Portland, Oregon. EndoSound is dedicated to expanding access to endoscopic ultrasound technology around the world. With its patented design, EndoSound transforms an upper endoscope into a fully functional EUS scope. It is comprised of an experienced team of scientists, engineers, clinicians, and seasoned business professionals with a track record of bringing new medical devices to market.
About AdaptivEndo: AdaptivEndo is a pioneer in single-use endoscopy solutions, offering a range of innovative products designed to improve patient safety and streamline medical procedures. The company is dedicated to making advanced endoscopic technology accessible to healthcare professionals worldwide, with a focus on enhancing patient outcomes and infection control.
Patient preference for comfortable, easy-access cancer care driving trend to outpatient settings
A full range of emotions can come with a cancer diagnosis. One of the most common? Loss of control.
In the wake of this difficult medical news, it’s hard for many not to feel defined by their illness. Appointments and tests start to fill the calendar every week, and with so many unknowns regarding response to treatment, it’s easy to feel as if everything is unmanageable.
Tack on the anxiety over prognosis and the potentially tricky treatment road ahead, and individuals can suddenly feel overwhelmed.
First Things First
To regain some control, one of the best first steps is to set a concrete plan forward for treatment and care. The lists of required scans, blood work, therapies, and treatments start to pile up quickly, and having a clear path toward remission is helpful.
As the appointments mount, the advantage of seeking treatment at an outpatient setting or an ambulatory surgery center (ASC) is clear. With ASCs, patients benefit from easier geographic access to treatment without traveling to and navigating large hospitals. Additionally, they can typically find more flexible scheduling options and even be seen for treatments sooner or more regularly than in a hospital.
With the flexibility of scheduling, patients feel that their care is prioritized as they do not often have to wait as long for appointments. Typically, physicians at ASCs are more able to accommodate a patient’s scheduling needs.
Living Beyond a Diagnosis
Outpatient centers are also more desirable for many patients because the additional services offered provide a glimpse into what life will be like when the battle ends and the cancer is defeated. Ancillary services, including physical therapy, nutrition and dietetics, and psychological services right on-site in an ASC or outpatient clinic, promote hope and help patients regain control.
But, perhaps most importantly, the most significant driver behind the trend out of hospitals for cancer care is the patient preference for the familiar. Aside from the convenience and ease of access, including more accessible parking and less time spent at the ASC, outpatient care is more comfortable compared to going into a hospital regularly. And when facing something as difficult as a cancer battle, every bit of comfort can make an impact.