blood flow 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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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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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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Odin wins INVEST Pitch Perfect Contest
Odin Technologies’ intelligent wearable medical device for diagnosing compartment syndrome won the diagnostics track at the Pitch Perfect startup competition. The track was sponsored by Invetech. Odin Technologies was announced as the winner of the diagnostics startup track at the Pitch Perfect Contest that took place during the MedCity INVEST Conference in Chicago on April 23-24. ...
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Rapid Medical Gains FDA Clearance for the Smallest & Only Adjustable Thrombectomy Device
Rapid Medical, a leading developer of advanced neurovascular devices, announces FDA 510(k) clearance for TIGERTRIEVER 13 for large vessel occlusions at the 2022 Society of NeuroInterventional Surgery’s (SNIS) 19th Annual Meeting in Toronto. TIGERTRIEVER 13 is the smallest revascularization device in the world to date and is designed to remove thrombus from delicate brain blood vessels ...
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Flosonics Medical closes US$14M funding round and expands Board of Directors
The funds will be used to pursue the commercialization of Flosonics Medical’s wireless Doppler ultrasound patch in addition to new product development Flosonics Medical recently announced the close of a $14 million USD funding round led by Arboretum Ventures in partnership with existing investors iGan Partners and Genesys Capital. The Canadian medical device company headquartered in ...
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Rapid Medical Enrolls the First Patient in the DISTALS Stroke Trial–Offering Treatment to New Ischemic Stroke Patient Population
Rapid Medical, a leading developer of advanced neurovascular devices, announced today the enrollment of the first patient in the DISTALS Study. The trial is the first-ever FDA investigational device exemption (IDE) trial to examine the safety and effectiveness of mechanical thrombectomy in distal stroke. “Enrolling the first patient in this landmark study is an important milestone for ...
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Medical Microinstruments’ Symani Surgical System Saves Patient’s Arm from Amputation
CALCl, Italy, July 13, 2021- Medical Microinstruments (MMI) SpA, a robotics company dedicated to improving clinical outcomes for patients undergoing microsurgery, announced today that MMI's Symani® Surgical System was successfully used at Careggi University Hospital Florence by Prof. Marco Innocenti and his team in a complex, post-traumatic limb reconstruction that saved a patient's arm from ...
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XyloCor Therapeutics Doses Patients in Phase 1/2 Trial Evaluating Novel Gene Therapy XC001 in Refractory Angina
XyloCor Therapeutics today announced it has successfully dosed the first two patients in the EXACT Trial, a Phase 1/2 dose escalation trial evaluating the safety, tolerability and efficacy of its lead candidate XC001 in patients with refractory angina. The trial will enroll patients who are not responding to medication and are unsuitable for coronary artery bypass graft or percutaneous coronary ...
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Rex Medical Completes Patient Enrollment for the REVEAL Peripheral Atherectomy U.S. Trial
CONSHOHOCKEN, Pa. Mar. 19, 2019 --(BUSINESS WIRE)--Rex Medical, L.P., a medical device design and development company, today announced the successful completion of enrollment in the Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization (REVEAL) IDE clinical trial. The REVEAL trial is a single arm, prospective study to evaluate the safety ...
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ELIXIR MEDICAL ANNOUNCES OUTSTANDING 24-MONTH DATA FOR DYNAMX CORONARY BIOADAPTOR SYSTEM, DEMONSTRATING STRONG SAFETY WITH NO TARGET LESION REVASCULARIZATION, MYOCARDIAL INFARCTION OR THROMBOSIS THROUGH 24 MONTHS
MILPITAS, Calif. – January 27, 2020 – Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced the 24-month clinical results for the DynamX™ Coronary Bioadaptor System, the first drug-eluting coronary artery implant that adapts to vessel physiology. The results were presented at the 30th Annual Live Interventions in Vascular Endotherapy ...
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XyloCor Therapeutics Achieves Target Enrollment in Phase 2 EXACT Study of XC001 Novel Gene Therapy for Ischemic Heart Disease
Positive Phase 1 results reported at the American Association for Thoracic Surgery (AATS) and the American Society of Gene and Cell Therapy (ASGCT) revealed XC001 is well tolerated at all dose levels Phase I data support XC001 therapeutic effect and potential dose response Topline Phase 2 data readout expected in February 2023 with interim results in the second half of this year XyloCor ...
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Vascugen Licenses Stem Cell Technology for Blood Vessel Regeneration Developed at IU School of Medicine
Vascuqen Inc. today announced that it has licensed a suite of intellectual property developed at the Indiana University (IU) School of Medicine related to blood vessel formation from adult stem cells. The regenerative medicine company is focused on finding therapies to repair tissues damaged by reduced blood flow due to disease or injury. The worldwide, exclusive licenses include patent rights ...
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