Surgery Monitoring News
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FDA clears Sonavex’s ultrasound blood flow monitor
Sonavex scored FDA clearance for its technology that uses ultrasound imaging and deep learning to deliver blood flow data on demand. The EchoSure system is cleared for use with the company’s EchoMark bioresorbable tissue markers, which got the agency’s nod in June. “The key goal is to be able to detect the problems associated with microvascular and vascular surgeries with ...
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AI ‘Fingerprinting’ Fights Back Against Hard-to-Detect Cancers
Hard-to-detect cancers like glioblastoma can have survival rates in the single-digit percentages and require elaborate techniques to detect, treat, and monitor. Reveal Surgical is working on changing that reality through its new, AI-based Sentry technology, which leverages a combination of AI and Raman spectroscopy to provide real-time tissue diagnostics during surgery for otherwise-invisible ...
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Veteran-Owned Company, in Partnership With Synaptive Medical, Awarded Medical Equipment ECAT Contract for Modus V™
Fidelis Sustainability Distribution, a veteran-owned company, has been awarded a Medical Equipment ECAT contract by the Defense Logistics Agency valued at $45,000,000 USD over 5 years. The ECAT contract is an online source (electronic catalog) for Robotic Assisted Surgery and other OR related products and acts as one of the preferred purchasing sources for the Department of Defense (DoD) and the ...
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First-Ever Four-Year MIGS Pivotal Trial Results Show Hydrus Microstent Significantly Reduces Need for Invasive Surgery and Subsequent Glaucoma Medication
Ivantis, Inc., developer of the novel Hydrus® Microstent, a minimally invasive glaucoma surgery (MIGS) device designed to lower eye pressure for open-angle glaucoma patients, announced today the first-ever, four-year follow-up data for a MIGS device in an FDA pivotal trial. The latest findings from the HORIZON study confirm the benefits of the Hydrus Microstent seen in earlier follow-up and ...
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Ivantis Completes Enrollment of International SPECTRUM Registry for Hydrus Microstent
SPECTRUM, the world’s largest single-device registry in ophthalmology, has completed enrollment. The announcement was made today by Ivantis Inc., a company dedicated to developing new and innovative solutions for glaucoma. SPECTRUM is a patient registry for the Hydrus® Microstent, a microinvasive glaucoma surgery (MIGS) device to treat patients with mild to moderate primary open-angle ...
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Gauss Announces Triton Platform Update to Power Maternal Hemorrhage Response
Gauss, the leader in AI-enabled surgical applications, announced an over-the-air software update, Triton QBL, that pairs the company’s AI-powered blood loss monitor with integrated protocols and provider alerts that help to synchronize postpartum hemorrhage care. The update will be available to the company’s network of hospital customers this fall. The United States has the highest ...
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NIH Awards Sonavex, Inc. $3 Million Grant to Pursue New Vascular Surgery Applications for EchoMark & EchoSure
Sonavex, Inc., a privately held medical device company focused on empowered patient care, announced that it received a $3 million Phase IIB Small Business Innovation Research (SBIR) grant from the National Institutes of Health to use its EchoMark & EchoSure devices to support arteriovenous (AV) fistula maturation and long-term viability. The award provides capital for prospective clinical ...
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FDA approves Sonavex`s EchoSure system
The FDA has granted its seal of approval to Sonavex to begin shipping its EchoSure system to providers across the U.S. A combination of 3D ultrasound imaging and advanced deep learning algorithms, the device automates visual and quantitative analysis to monitor and provide up-to-date information on blood flow following surgical procedures. “Doppler ultrasound is an accurate imaging ...
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Sonavex Receives FDA 510(k) Clearance for EchoSure
Sonavex, Inc., a privately held medical device company focused on empowered patient care, announced today that on March 8, 2019 it received 510(k) clearance from the U.S. Food and Drug Administration for its EchoSureTM device to deliver definitive blood flow data on demand. The EchoSure system combines 3D ultrasound imaging with advanced deep learning algorithms to automate visual and ...
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FierceHealthcare Names Gauss Surgical as One of Its 2019 “Fierce 15” Companies
Gauss Surgical today announced that it has been named by FierceHealthcare as one of the 2019 Fierce 15 companies, designating it as one of the most promising healthcare companies in the industry. Gauss Surgical is an AI-driven healthcare technology company that is evolving the delivery model for medical devices and services in hospitals. The company’s flagship product, Triton, monitors ...
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Gauss Raises $20 Million in Series C From Northwell Health Softbank Ventures Korea for AI-Enabled Platform for the Operating Room
Gauss Surgical, an AI-driven healthcare technology company, raised $20 million in Series C funding from Northwell Health and SoftBank Ventures Korea, the global early-stage venture capital arm of SoftBank Group, as well as from the LS Polaris Innovation Fund and seven other leading US health systems. The proceeds of the round will be used to accelerate the adoption of its Triton platform in ...
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Gauss Surgical Announces $12.6 Million Series B Financing
Gauss Surgical, Inc., maker of Triton, the world’s first and only platform for real-time monitoring of surgical blood loss, today announced the close of its $12.6 million in Series B financing, bringing its total funding to $24.6 million. Providence Ventures, the investment arm of Providence Health & Services, the third largest not-for-profit health system in the United States, led the ...
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Gauss Surgical Receives CE Mark Approval for Triton
Gauss Surgical, Inc. announced today that the company has received CE (Conformité Européenne) Mark for its Triton System™ for iPad, the world’s first and only mobile platform for real-time monitoring of surgical blood loss. This milestone allows Gauss to market and sell its system throughout Europe and other regions that require the CE Mark. Additionally, the company ...
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Gauss Surgical to Present Triton at UHC Annual Conference
Gauss Surgical, Inc. announced today that the company will compete in the annual “UHC Startup Challenge”, which will take place on Friday, October 2 in Orlando as part of the “Advance: UHC Annual Conference 2015”. The company will have the opportunity to present Triton, the world’s first and only mobile platform for real-time monitoring of surgical blood loss, to the ...
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Gauss Surgical Completes $12 Million Series A Financing; Proceeds to Propel Commercial Growth of World’s First Mobile Platform to Monitor Surgical Blood Loss
Gauss Surgical, Inc. announced today that the company has completed series A financing to accelerate sales growth and further commercialization of the Triton System™, the world’s first and only mobile platform for real-time monitoring of surgical blood loss. The latest round was led by Promus Ventures and joined by Summation Health Ventures and LifeForce Ventures. “As prior ...
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Gauss Surgical Announces FDA 510(k) Clearance of Triton Canister App for Accurate Surgical Blood Loss Monitoring
Gauss Surgical today announced that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Triton Canister App, the second core product in its Triton System™ portfolio, the world’s first and only mobile platform for real-time monitoring of surgical blood loss. Now, in addition to estimating blood loss on surgical sponges, the system can accurately ...
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