Posts by cstephenson@legacymedsearch.com
FDA Clears New Mechanical Thrombectomy Platform
Control Medical Technology announced the FDA cleared the Aspire MAX 7 – 11F Mechanical Thrombectomy platform to remove blood clots from peripheral vessels. Blood clot removal (thrombectomy) is a common procedure. Coronary thrombectomy is associated with acute myocardial infarction (AMI), neurovascular thrombectomy is associated with acute ischemic stroke, and peripheral thrombectomy is associated with peripheral…
Read MoreFDA Grants Emergency Use Authorization to VitalConnect for Cardiac Monitoring in COVID-19 Patients
VitalConnect®, Inc., a leader in wearable biosensor technology, announced it was granted Emergency Use Authorization (EUA) status by the U.S. Food and Drug Administration (FDA) as part of the response to the COVID-19 pandemic. The FDA EUA will further enhance the capabilities of the VitalPatch and continuous patient monitoring technology, the Vista Solution. Under the FDA EUA, the…
Read MoreVentFree Respiratory Muscle Stimulator Receives FDA Emergency Use Authorization for Use During COVID-19 Pandemic
Liberate Medical today announced that it has received Federal Drug Administration (FDA) Emergency Use Authorization for its VentFree™ Respiratory Muscle Stimulator, intended to be used to reduce disuse atrophy of the abdominal wall muscles, which may reduce the number of days adult patients require mechanical ventilation, including those patients with COVID-19. Reducing the time patients…
Read MoreCerus Corporation Announces FDA Approval for INTERCEPT Blood System for Plasma with Alternate Plastic Disposable Kits
Cerus Corporation (Nasdaq:CERS) announced today FDA regulatory approval for manufacture of INTERCEPT plasma with a new, alternative plastic disposable kit. The planned conversion to these new kits is part of the Company’s ongoing strategy to enhance its global supply chain integrity that was initiated several years ago. “The FDA approval for the new INTERCEPT plasma…
Read MoreCenterline Biomedical Completes First Human Patient in the United States with IOPS (Intra-Operative Positioning System)
Surgical navigation startup Centerline Biomedical, Inc. (Centerline), a Cleveland Clinic spin-off company, has announced the successful completion of the first in a series clinical cases in the United States as it begins limited launch of its innovative IOPS™ technology platform. The FDA-cleared technology is being deployed at Cleveland Clinic to begin, with other leading intuitions to follow,…
Read MoreSynaptive Medical Secures FDA Clearance for Evry
Synaptive Medical, a leader in robotic surgical visualization, announced today the company has secured clearance from the Food and Drug Administration (FDA) for its superconducting, head magnetic resonance imaging (MRI) technology, Evry™. Synaptive developed Evry to provide medical professionals with diagnostic imaging capabilities directly at the point of care in critical care settings, which was…
Read MoreAbiomed Expands Product Portfolio with Acquisition of Cardiopulmonary Support Technology to Improve Outcomes for Patients
Abiomed, maker of the Impella heart pump, has acquired Breethe, developer of a novel extracorporeal membrane oxygenation (ECMO) system that will complement and expand Abiomed’s product portfolio to more comprehensively serve the needs of patients whose lungs can no longer provide sufficient oxygenation, including patients suffering from cardiogenic shock or respiratory failure such as due to ARDS,…
Read MoreHeartVista Closes $8.65M Series A Financing Led by Khosla Ventures
HeartVista, a pioneer in AI-assisted MRI solutions, today announced the closing of a $8.65M Series A financing round. The round was led by Khosla Ventures, Jeff Rothschild, Leslie Ventures, Open Field Capital, and additional investors. Combined with several grants from the National Institutes of Health (NIH), this latest raise brings the company’s total funding to…
Read MoreLungpacer Medical Receives FDA Emergency Use Authorization to Wean Patients Off Mechanical Ventilation During Covid Crisis
Lungpacer Medical announced today that the U.S. Food and Drug Administration has issued Emergency Use Authorization (EUA) for the Company’s novel Diaphragmatic Pacing Therapy System (DPTS) for immediate use in patients on invasive mechanical ventilators at high risk of weaning failure, including COVID-19 patients. “We are thrilled to hear about the FDA’s decision to grant…
Read MoreMolekule Launches New Commercial Product, Air Pro RX, with FDA 510(k) Class II Medical Device Clearance
Molekule, the leader in reinventing air purification, today announced that the U.S. Food and Drug Administration (FDA) cleared the 510(k) premarket notification for its new medical-grade air purifier, Air Pro RX, classifying it as a 510(k) Class II Medical Device. The Molekule Air Pro RX air purifier is intended for medical purposes to destroy bacteria and viruses in…
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