The first Ambulatory Surgery Center (ASC) in the U.S. opened in 1970, offering an opportunity for patients to have access to the quality care they needed, without the wait time and cost often associated with hospitals.
Large investments from MedTech industry giants may help fuel the still growing trend for out of hospital care. A recent partnership of GE Healthcare and Medtronic announced in April promises “cost-effective advanced technology” support for the growing suite of ASCs across the country.
The question remains how ASCs will be able to adapt to the increased demand for outpatient care when it comes to more advanced procedures – especially those performed by physicians with specialized training and requiring costly equipment, typically only found in hospitals.
GI Care in the ASC
In gastroenterology, there has been a huge uptick to procedures in ASCs, especially for routine endoscopy. Since ASCs typically offer a more convenient location, time-saving, and cost-saving alternative, they can be especially attractive to patients needing a routine colonoscopy.
The ASC Association lists endoscopy as one the primary specialties certain ASCs may offer (about 32 percent). Definitive Healthcare reported colonoscopies topped the list of reported procedures charged at ASCs in 2018 – approximately $3.2 billion in submitted claims.
Since average costs for colonoscopies can range from around $3,000 to as high as $19,000, it’s not surprising patients are choosing ASCs over the hospital for routine care.
As another example, a review of South Carolina colonoscopy rates and locations found that while the number of procedures stayed constant between 2001 and 2017, there was an 125 percent increase in colonoscopies performed in urban ASCs in that timespan.
EUS Outside of the Hospital
As the number of ASC sites grows and advanced medical technology becomes more readily available, there have been signs that more specialized gastroenterological endoscopy procedures may become more popular at the ASC as well.
Endoscopic ultrasound (EUS) is a minimally invasive procedure used to diagnose disease in the digestive and respiratory tracts. An alternative to surgery, EUS tools allow physicians to take images and samples for biopsies with specialized endoscopes. EUS is typically performed in the hospital endoscopy unit with patients under general anesthesia.
Given the expense of EUS technology and specialization required from physicians, transitioning procedures to an ASC could prove burdensome, with few doctors able to perform the procedures at these locations. A 2016 study from Dr. Shaffer R. S. Mok, et al, out of the MD Anderson Cancer Center in Jersey shows the feasibility and safety of EUS in the ASC, and the idea has gained more traction in recent years.
Continued innovation of EUS technology could be one of the ways to help move procedures to the ASC from the hospital, at great benefit to patients.
https://www.endosound.com/wp-content/uploads/2022/06/GI-Endoscopy-Already-Popular-in-ASCs-Will-EUS-Be-Next.jpg300835KG-Endosoundhttp://www.endosound.com/wp-content/uploads/2023/08/Endosound-New-web-logo-no-tag2023.pngKG-Endosound2022-06-03 17:12:482022-06-06 15:29:10Routine GI Endoscopy Already Popular in ASCs, Will EUS Be Next?
May 5th, 2022. In April in San Francisco, CA, home to inventors, innovators, and investors, the 2022 AGA Center for GI Innovation and Technology (CGIT) Summit got underway. There was a lot of great interaction among medical providers, investors and industry and one of the highlights was the Shark Tank style competition among start-up companies in the GI space.
Twenty companies applied for 6 spots to compete live in San Francisco and EndoSound® was selected among the 6 finalists. Competitors each presented a 5-minute elevator pitch to a panel of GIs and investors, followed by 5-10 minutes of questions. Our founder, Steven Steinberg, MD, did a fabulous job pin-pointing the important details the panelists were seeking.
This win further validates that our technology is ready to disrupt the EUS market. Along with the award recognition, we will also receive guidance from the AGA CGIT committee, providing access to additional funding and partnering opportunities. We could not be more excited!
As the 2022 AGA CGIT Shark Tank winner, we will represent the AGA CGIT in the Shark Tank competition at Digestive Disease Week (DDW) on May 21st, 2022, in San Diego, CA. Once again Dr. Steinberg will be there to demonstrate our disruptive product and business plan.
Stay tuned for more information as we get closer to realizing our goals and more collaboration between the professional societies, strategic partners, and the GI community.
https://www.endosound.com/wp-content/uploads/2022/05/EndoSound-Shark-Tank-Winner-Header.jpg365835KG-Endosoundhttp://www.endosound.com/wp-content/uploads/2023/08/Endosound-New-web-logo-no-tag2023.pngKG-Endosound2022-05-06 13:31:352024-05-30 06:26:12EndoSound® is the Winner of the 2022 Shark Tank Competition at the AGA Center for GI Innovation and Technology
PORTLAND—August 31, 2021—Endosound, Inc., an Oregon-based medical device innovator developing technologies that enhance access, reduce cost, and increase the safety of endoscopic ultrasound procedures, announced today that its EndoSound Vision System received a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).
The EndoSound Vision System is an add-on device that consists of a compact ultrasound beamformer, reusable transducer, and disposable mounting kit that fastens onto any flexible upper gastrointestinal (GI) video endoscope to convert it into an endoscopic ultrasound (EUS) system. Its unique distal attachment allows the endoscopist to perform advanced procedures, such as fine needle biopsy, with precision, but without the controversial elevator mechanism found on all other linear echo-endoscopes.
In recent years, multi-use endoscopes that feature an elevator mechanism have faced scrutiny due to their association with patient infection risk. In a July 2020 Safety Communication published by the FDA, it was stated that “FDA recommends health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components”1 to address the challenges presented by the elevator mechanisms on these endoscopes. Major device manufacturers have consequently responded with new disposable duodenoscope models, but the similarly designed ultrasound endoscopes have been overlooked. The innovative EndoSound Vision System addresses this oversight by eliminating the need for the elevator mechanism while still maintaining the precision and imaging that is necessary for complex EUS procedures.
“The EndoSound Vision System removes significant patient safety concerns that have been connected with the elevator mechanism over the last several years,” stated Dr. Shyam S. Varadarajulu, MD, Medical Director of the Digestive Health Institute at Orlando Health.“In addition to reducing risk, the system features a disruptive price point that gives it the potential to dramatically expand the availability of this critical modality in the United States and around the world.”
“The Breakthrough Device Designation is evidence of the transformative potential the EndoSound Vision System presents,” stated Dr. Stephen Steinberg, MD, EndoSound Founder and President. “There is a clear need for a resolution to the patient safety risk presented by traditional ultrasound endoscopes. Also, for many healthcare facilities, the high cost of conventional systems creates a barrier to entry into the use of endoscopic ultrasound. With Breakthrough Device Designation, we are on an accelerated pathway to eliminating these obstacles.”
The FDA Breakthrough Device Designation expedites the development and evaluation of novel devices that offer the potential to enhance patient outcomes through more effective treatment or improved diagnosis of life-threatening conditions. Under the program, the FDA will provide EndoSound with the opportunity to provide its feedback during the pre-market phase and prioritized review of the device submission.
About EndoSound
Endosound, Inc., is a privately held company based in Portland, Oregon that is dedicated to expanding access to endoscopic ultrasound technology around the world. The company comprises an experienced team of scientists, engineers, clinicians, and business professionals with track records of commercializing new medical devices.
Routine GI Endoscopy Already Popular in ASCs, Will EUS Be Next?
General News, Industry News, Updates in GIThe first Ambulatory Surgery Center (ASC) in the U.S. opened in 1970, offering an opportunity for patients to have access to the quality care they needed, without the wait time and cost often associated with hospitals.
Fast forward 50 years and the global COVID-19 pandemic fueled an already growing trend of patient preference for the convenience of ASCs. Today, more than 30 million surgeries and procedures are performed at more than 5,800 ASCs nationwide every year.
Large investments from MedTech industry giants may help fuel the still growing trend for out of hospital care. A recent partnership of GE Healthcare and Medtronic announced in April promises “cost-effective advanced technology” support for the growing suite of ASCs across the country.
The question remains how ASCs will be able to adapt to the increased demand for outpatient care when it comes to more advanced procedures – especially those performed by physicians with specialized training and requiring costly equipment, typically only found in hospitals.
GI Care in the ASC
In gastroenterology, there has been a huge uptick to procedures in ASCs, especially for routine endoscopy. Since ASCs typically offer a more convenient location, time-saving, and cost-saving alternative, they can be especially attractive to patients needing a routine colonoscopy.
The ASC Association lists endoscopy as one the primary specialties certain ASCs may offer (about 32 percent). Definitive Healthcare reported colonoscopies topped the list of reported procedures charged at ASCs in 2018 – approximately $3.2 billion in submitted claims.
Since average costs for colonoscopies can range from around $3,000 to as high as $19,000, it’s not surprising patients are choosing ASCs over the hospital for routine care.
As another example, a review of South Carolina colonoscopy rates and locations found that while the number of procedures stayed constant between 2001 and 2017, there was an 125 percent increase in colonoscopies performed in urban ASCs in that timespan.
EUS Outside of the Hospital
As the number of ASC sites grows and advanced medical technology becomes more readily available, there have been signs that more specialized gastroenterological endoscopy procedures may become more popular at the ASC as well.
Endoscopic ultrasound (EUS) is a minimally invasive procedure used to diagnose disease in the digestive and respiratory tracts. An alternative to surgery, EUS tools allow physicians to take images and samples for biopsies with specialized endoscopes. EUS is typically performed in the hospital endoscopy unit with patients under general anesthesia.
Given the expense of EUS technology and specialization required from physicians, transitioning procedures to an ASC could prove burdensome, with few doctors able to perform the procedures at these locations. A 2016 study from Dr. Shaffer R. S. Mok, et al, out of the MD Anderson Cancer Center in Jersey shows the feasibility and safety of EUS in the ASC, and the idea has gained more traction in recent years.
Continued innovation of EUS technology could be one of the ways to help move procedures to the ASC from the hospital, at great benefit to patients.
EndoSound® is the Winner of the 2022 Shark Tank Competition at the AGA Center for GI Innovation and Technology
Company NewsMay 5th, 2022. In April in San Francisco, CA, home to inventors, innovators, and investors, the 2022 AGA Center for GI Innovation and Technology (CGIT) Summit got underway. There was a lot of great interaction among medical providers, investors and industry and one of the highlights was the Shark Tank style competition among start-up companies in the GI space.
Twenty companies applied for 6 spots to compete live in San Francisco and EndoSound® was selected among the 6 finalists. Competitors each presented a 5-minute elevator pitch to a panel of GIs and investors, followed by 5-10 minutes of questions. Our founder, Steven Steinberg, MD, did a fabulous job pin-pointing the important details the panelists were seeking.
Without further delay,…
We won!
https://www.linkedin.com/company/endosound/posts/?feedView=all&viewAsMember=true
This win further validates that our technology is ready to disrupt the EUS market. Along with the award recognition, we will also receive guidance from the AGA CGIT committee, providing access to additional funding and partnering opportunities. We could not be more excited!
As the 2022 AGA CGIT Shark Tank winner, we will represent the AGA CGIT in the Shark Tank competition at Digestive Disease Week (DDW) on May 21st, 2022, in San Diego, CA. Once again Dr. Steinberg will be there to demonstrate our disruptive product and business plan.
Stay tuned for more information as we get closer to realizing our goals and more collaboration between the professional societies, strategic partners, and the GI community.
FDA Grants Breakthrough Device Designation for Innovative EndoSound Vision Ultrasound System
Company NewsThe EndoSound Vision System is an add-on device that consists of a compact ultrasound beamformer, reusable transducer, and disposable mounting kit that fastens onto any flexible upper gastrointestinal (GI) video endoscope to convert it into an endoscopic ultrasound (EUS) system. Its unique distal attachment allows the endoscopist to perform advanced procedures, such as fine needle biopsy, with precision, but without the controversial elevator mechanism found on all other linear echo-endoscopes.
In recent years, multi-use endoscopes that feature an elevator mechanism have faced scrutiny due to their association with patient infection risk. In a July 2020 Safety Communication published by the FDA, it was stated that “FDA recommends health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components”1 to address the challenges presented by the elevator mechanisms on these endoscopes. Major device manufacturers have consequently responded with new disposable duodenoscope models, but the similarly designed ultrasound endoscopes have been overlooked. The innovative EndoSound Vision System addresses this oversight by eliminating the need for the elevator mechanism while still maintaining the precision and imaging that is necessary for complex EUS procedures.
“The EndoSound Vision System removes significant patient safety concerns that have been connected with the elevator mechanism over the last several years,” stated Dr. Shyam S. Varadarajulu, MD, Medical Director of the Digestive Health Institute at Orlando Health.“In addition to reducing risk, the system features a disruptive price point that gives it the potential to dramatically expand the availability of this critical modality in the United States and around the world.”
“The Breakthrough Device Designation is evidence of the transformative potential the EndoSound Vision System presents,” stated Dr. Stephen Steinberg, MD, EndoSound Founder and President. “There is a clear need for a resolution to the patient safety risk presented by traditional ultrasound endoscopes. Also, for many healthcare facilities, the high cost of conventional systems creates a barrier to entry into the use of endoscopic ultrasound. With Breakthrough Device Designation, we are on an accelerated pathway to eliminating these obstacles.”
The FDA Breakthrough Device Designation expedites the development and evaluation of novel devices that offer the potential to enhance patient outcomes through more effective treatment or improved diagnosis of life-threatening conditions. Under the program, the FDA will provide EndoSound with the opportunity to provide its feedback during the pre-market phase and prioritized review of the device submission.
About EndoSound
Endosound, Inc., is a privately held company based in Portland, Oregon that is dedicated to expanding access to endoscopic ultrasound technology around the world. The company comprises an experienced team of scientists, engineers, clinicians, and business professionals with track records of commercializing new medical devices.
www.endosound.com
1. U.S. Food and Drug Administration. (2020). The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication [online]. Available at: https://www.fda.gov/medical-devices/safety-communications/fda-recommending-transition-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication [Accessed 13 Jul. 2021].