Posts by cstephenson@legacymedsearch.com
FDA Awards HistoSonics Clearance of its First-of-a-Kind Edison® Histotripsy System
HistoSonics®, (www.histosonics.com), the manufacturer of the Edison® System and novel histotripsy therapy platforms, announced today the marketing authorization of its “Breakthrough” platform via the U.S. Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate. Marketing authorization makes Edison the first and only histotripsy…
Read MoreCadence Announces the Acquisition of ARC Group Worldwide’s Florida Location
Cadence, Inc., a leading provider of design, development, and contract manufacturing services to the medical device, drug delivery, and diagnostics markets, announced today that it has acquired the Florida location of ARC Group Worldwide (arcw.com), a precision manufacturer specializing in Metal Injection Molding (MIM) and cleanroom plastic injection molding. ARC Florida is located in DeLand, Fla. “Acquiring ARC Florida is…
Read MoreStimdia Medical Inc. Initiates FDA Approved IDE Pivotal Trial to Investigate Impact of Neuromuscular Stimulation on Mechanically Ventilated Patients
Stimdia Medical, a medical device company developing innovative technologies to improve respiratory care, today announced the initiation of its FDA approved pivotal trial to investigate the impact of phrenic nerve stimulation (PNS) on the time to liberate patients from mechanical ventilation. The ReInvigorate Study is a randomized, controlled trial that will enroll approximately 420 patients…
Read MoreFDA Grants ExThera Multiple Breakthrough Device Designations for its Seraph® 100 Filter
ExThera Medical Corporation, a healthcare company developing and manufacturing extracorporeal pathogen technologies, announces that it has received multiple Breakthrough Device Designations from the U.S. Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100). The Seraph 100 is a patented blood filter containing a biomimetic surface, similar to that found…
Read MoreEnable Injections Receives First U.S. Food and Drug Administration (FDA) Approval
Enable Injections, Inc. (“Enable”) today announced that the U.S. Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse®) for the subcutaneous delivery of EMPAVELI® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. for adults with paroxysmal nocturnal hemoglobinuria (PNH). The EMPAVELI Injector is a compact, wearable injector designed to streamline the self-administration experience with minimal…
Read MoreThe FDA Approves IDE for ReGelTec’s Pivotal Study of HYDRAFIL® for Chronic Low Back Pain due to Degenerative Disc Disease
ReGelTec, Inc., announced that the U.S. Food and Drug Administration has approved an IDE for the company’s pivotal study to support premarket approval of its HYDRAFIL® System. The HYDRAFIL System contains an injectable polymer that is implanted percutaneously via a needle to augment the native disc in a procedure performed under local anesthesia at an…
Read More4WEB Medical Receives 510k Clearance to Market New Integrated Cervical Plate
4WEB Medical, an orthopedic implant company focused on developing innovative implants that utilize its proprietary Truss Implant Technology™, announced that it has received 510K clearance to market the newest additions to the company’s implant portfolio, the Cervical Spine Truss System (CSTS) Integrated Plating Solution and two cervical interbody line extensions which include implants with 12 degrees of…
Read MoreQT Medical® Announces Completion of Series B Financing of $12 Million
QT Medical, Inc., a medtech company focused on cardiac care technology, announced today that it raised $12 million in Series B financing. This funding will accelerate QT Medical’s market penetration, global expansion, product pipeline development, and long-term strategic planning. QT Medical aims to provide improved cardiac devices and services to revolutionize the care of patients with heart disease.…
Read MoreSaluda Medical Receives FDA Approval for Evoke® System MRI Labeling
Saluda Medical, Inc. (“Saluda Medical”), a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies, today announced that the U.S. Food and Drug Administration (FDA) has approved MRI conditional labeling for the Evoke® System, the first and only precision, dose-control spinal cord stimulation (SCS) therapy…
Read MoreChoiceSpine® Announces Standalone Indication for Blackhawk® Ti 3D Printed Cervical Spacer System
ChoiceSpine LLC, a privately held spinal device company held by Altus Capital Partners in Knoxville, TN, is pleased to announce today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market the Blackhawk® Ti 3D Printed Cervical Spacer System with standalone clearance. Blackhawk® Ti utilizes preassembled integrated anchor technology with a proven…
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