CorVascular News
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All New VasoGuard Systems Introduced at SDMS Annual Conference in New Orleans
New PAD Diagnostic Suite Designed for Vascular Sonographers
New Orleans -- September 26, 2024 -- CorVascular, a leading producer of peripheral arterial disease (PAD) / peripheral vascular disease (PVD) testing devices, began offering live demonstrations of its recently FDA-cleared VasoGuard V-Series medical devices. The company selected the 2024 Society of Diagnostic Medical Ultrasound (SDMS) annual conference to showcase the new products.
CorVascular received FDA clearance in July and immediately begin production in order to deliver devices to clinics, hospitals, and teaching institutions across the country. “We are very excited to show the industry our new entrants into what has been a fairly stagnant response from the competition to the needs of vascular techs over the last decade. The SDMS Annual Conference is a great event and we look forward to showcasing our new products,” said Spencer Lien, Founder and Managing Director at CorVascular.
There are five new VasoGuard models being introduced and each include features not seen among legacy offerings, including IP67 rated waterproof PPG sensors, independent pressure channels each equipped with an air flow sensor for Calibrated Pulse Volume Recording (C-PVR), and a built-in USB hub. The VasoGuard product platform ranges from the V2 (two independent pumps and two PPGs) up to the V10 with 10 independent pumps, three Doppler ports, and five PPGs. These are just a few of the many features that makes the VasoGuard models a significant leap forward for physiologic testing.
About CorVascular
CorVascular develops, manufactures, and markets innovative vascular testing technologies and is committed to its core strength in delivering accurate and reliable solutions to healthcare providers. Proudly headquartered and producing its products in the USA in the great state of Minnesota, CorVascular is privately held, eco-conscious, and an equal opportunity employer.
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New PAD Diagnostic Suite Designed for Vascular Sonographers
New Orleans -- September 26, 2024 -- CorVascular, a leading producer of peripheral arterial disease (PAD) / peripheral vascular disease (PVD) testing devices, began offering live demonstrations of its recently FDA-cleared VasoGuard V-Series medical devices. The company selected the 2024 Society of Diagnostic Medical Ultrasound (SDMS) annual conference to showcase the new products.
CorVascular received FDA clearance in July and immediately begin production in order to deliver devices to clinics, hospitals, and teaching institutions across the country. “We are very excited to show the industry our new entrants into what has been a fairly stagnant response from the competition to the needs of vascular techs over the last decade. The SDMS Annual Conference is a great event and we look forward to showcasing our new products,” said Spencer Lien, Founder and Managing Director at CorVascular.
There are five new VasoGuard models being introduced and each include features not seen among legacy offerings, including IP67 rated waterproof PPG sensors, independent pressure channels each equipped with an air flow sensor for Calibrated Pulse Volume Recording (C-PVR), and a built-in USB hub. The VasoGuard product platform ranges from the V2 (two independent pumps and two PPGs) up to the V10 with 10 independent pumps, three Doppler ports, and five PPGs. These are just a few of the many features that makes the VasoGuard models a significant leap forward for physiologic testing.
About CorVascular
CorVascular develops, manufactures, and markets innovative vascular testing technologies and is committed to its core strength in delivering accurate and reliable solutions to healthcare providers. Proudly headquartered and producing its products in the USA in the great state of Minnesota, CorVascular is privately held, eco-conscious, and an equal opportunity employer.
Follow CorVascular on X, Facebook, LinkedIn, and all other platforms.
Media Contact
CorVascular’s Earns FDA 510(k) Clearance
Comprehensive suite of peripheral vascular testing devices set to enter US market
Minneapolis -- July 29, 2024 -- CorVascular, a leading producer of peripheral arterial disease (PAD) / peripheral vascular disease (PVD) testing devices, today announced the U.S. Food and Drug Administration (FDA) has cleared its VasoGuard V-Series as Class II medical devices. The clearance allows CorVascular to immediately begin marketing and selling the devices to clinics, hospitals, and teaching institutions across the country, expanding access to diagnostic testing for a disease medical experts say is causing an amputation epidemic in the US.
According to the American Heart Association, PAD / PVD is present in over 12 million Americans and 200 million individuals worldwide. In these patients, limb symptoms may reduce quality of life, and the devastating outcome of limb amputation results in social and economic burdens for both patient and family. Early identification allows for timely initiation of guideline-directed medical therapy for secondary prevention of cardiovascular disease, cerebrovascular disease, and limb events.
“FDA 510(k) clearance of the VasoGuard V-Series is a significant achievement for our entire team who has been working diligently on this milestone for several years,” said Spencer Lien, Founder and Managing Director at CorVascular. “The VasoGuard V-Series is the first full suite of devices designed for primary care, specialists, all the way up to and including the vascular testing labs in major health institutions and academic centers of excellence. It has been over a decade since anything new has come to this market and the VasoGuard is a perfect fit; the right line at the right time.”
The newly cleared VasoGuard suite includes five devices each with unique combination of sensors and capabilities, including up to three continuous wave Doppler probes with full color spectrum, up to five wearable photoplethysmography (PPG) sensors, and up to 10 pulse volume recording (PVR) channels.
The VasoGuard V-Series signifies a significant step forward for physiologic testing in international standards compliance. Unlike older legacy systems, VasoGuard achieved FDA clearance after having completed rigorous certification testing on the entire system, including electrical safety IEC 60601-1, electromagnetic disturbances IEC 60601-1-2, wireless immunity, cybersecurity, and all other standards required by FDA. These certifications included the device, touchscreen computer, mobile cart, and all accessories approved as a system; paving the way for fast acceptance with confidence by medical directors, hospital biomed, and IT decision-makers.
CorVascular is now accepting orders for its V2, V4, V6, V8, and V10 VasoGuard systems. Existing customers have the option to trade-up. Contact CorVascular for more information or to arrange a demonstration.
About CorVascular
CorVascular develops, manufactures, and markets innovative vascular testing technologies and is committed to its core strength in delivering accurate and reliable solutions to healthcare providers. Proudly headquartered and producing its products in the USA in the great state of Minnesota, CorVascular is privately held, eco-conscious, and an equal opportunity employer.
Follow CorVascular on X, Facebook, LinkedIn, and all other platforms.
Media Contact
Comprehensive suite of peripheral vascular testing devices set to enter US market
Minneapolis -- July 29, 2024 -- CorVascular, a leading producer of peripheral arterial disease (PAD) / peripheral vascular disease (PVD) testing devices, today announced the U.S. Food and Drug Administration (FDA) has cleared its VasoGuard V-Series as Class II medical devices. The clearance allows CorVascular to immediately begin marketing and selling the devices to clinics, hospitals, and teaching institutions across the country, expanding access to diagnostic testing for a disease medical experts say is causing an amputation epidemic in the US.
According to the American Heart Association, PAD / PVD is present in over 12 million Americans and 200 million individuals worldwide. In these patients, limb symptoms may reduce quality of life, and the devastating outcome of limb amputation results in social and economic burdens for both patient and family. Early identification allows for timely initiation of guideline-directed medical therapy for secondary prevention of cardiovascular disease, cerebrovascular disease, and limb events.
“FDA 510(k) clearance of the VasoGuard V-Series is a significant achievement for our entire team who has been working diligently on this milestone for several years,” said Spencer Lien, Founder and Managing Director at CorVascular. “The VasoGuard V-Series is the first full suite of devices designed for primary care, specialists, all the way up to and including the vascular testing labs in major health institutions and academic centers of excellence. It has been over a decade since anything new has come to this market and the VasoGuard is a perfect fit; the right line at the right time.”
The newly cleared VasoGuard suite includes five devices each with unique combination of sensors and capabilities, including up to three continuous wave Doppler probes with full color spectrum, up to five wearable photoplethysmography (PPG) sensors, and up to 10 pulse volume recording (PVR) channels.
The VasoGuard V-Series signifies a significant step forward for physiologic testing in international standards compliance. Unlike older legacy systems, VasoGuard achieved FDA clearance after having completed rigorous certification testing on the entire system, including electrical safety IEC 60601-1, electromagnetic disturbances IEC 60601-1-2, wireless immunity, cybersecurity, and all other standards required by FDA. These certifications included the device, touchscreen computer, mobile cart, and all accessories approved as a system; paving the way for fast acceptance with confidence by medical directors, hospital biomed, and IT decision-makers.
CorVascular is now accepting orders for its V2, V4, V6, V8, and V10 VasoGuard systems. Existing customers have the option to trade-up. Contact CorVascular for more information or to arrange a demonstration.
About CorVascular
CorVascular develops, manufactures, and markets innovative vascular testing technologies and is committed to its core strength in delivering accurate and reliable solutions to healthcare providers. Proudly headquartered and producing its products in the USA in the great state of Minnesota, CorVascular is privately held, eco-conscious, and an equal opportunity employer.
Follow CorVascular on X, Facebook, LinkedIn, and all other platforms.
Media Contact