Microvascular Disease Articles & Analysis
6 news found
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 ...
Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the treatment of small coronary artery lesions in Coronary Artery Disease (CAD). The proposed indication for use includes “The ...
Gesynta Pharma AB ("Gesynta"), a clinical stage company developing novel anti-inflammatory agents, today announced that the results from the successfully completed First-in-Human clinical study with its lead candidate GS-248 for the treatment of microvascular disease have been presented at the EULAR 2020 E-Congress. Following these results, Gesynta now intends to commence a Phase II study in ...
Gesynta Pharma AB ("Gesynta") announces the completion and positive results of a first clinical study with GS-248. The purpose of the study was to evaluate safety, tolerability, pharmacokinetic and pharmacodynamic properties of GS-248 after single and multiple ascending doses to healthy subjects. The results support the further clinical development of GS-248 in microvascular dysfunction and a ...
Profusa, a digital health company that is pioneering the next generation of personalized medicine, today announced research findings that suggest the company’s Lumee® Oxygen Platform may help improve the clinical management of patients with critical limb ischemia (CLI) who are undergoing endovascular revascularization treatment (EVT). The data, from a recent post-market clinical study ...
Gesynta Pharma AB ("Gesynta") announces that the first clinical study with GS-248 has been initiated and that the first healthy volunteers have been dosed. The purpose of the phase I study is to study safety, tolerability and pharmacokinetic properties of GS-248 as well as its effect on relevant biomarkers. Gesynta's lead candidate drug, GS-248, is a potent and selective inhibitor of ...