Posts by cstephenson@legacymedsearch.com
Aesculap Inc. Announces U.S. Launch of M.blue Hydrocephalus Valve
Aesculap Inc., in partnership with The Christoph Miethke GmbH & Co. KG (MIETHKE), is pleased to announce the launch of the M.blue valve, the latest generation of Hydrocephalus valve technology. Its unique gravitational technology is integrated with a fixed differential pressure unit in one valve, allowing for a simple, position-dependent solution. The M.blue valve is…
Read More3NT Medical Announces FDA Clearance for Colibri Endoscopy System
3NT Medical, a privately-held corporation dedicated to developing single-use specialized endoscopes for the diagnosis and treatment of ear, nose and throat (ENT) disorders, announced today the FDA 510(k) clearance for the Colibri™ Micro ENT Scope, the world’s first single-use endoscope specifically designed for Otology. The Colibri™ endoscopy system incorporates a lightweight ergonomic handpiece, a 2.2mm…
Read MoreArterys Raises $28 Million to Accelerate the Delivery of Medical AI to Practices Around the World
Arterys, a leading global medical imaging platform to deliver clinical AI products over the internet, just received its seventh USA FDA clearance and announced its latest round of funding — a $28 million Series C investment from a syndicate led by Benslie Investment Group and Temasek Holdings, with participation by Fosun, Revelation Partners, Emergent Medical…
Read MoreFDA Issues Emergency Use Authorization for Impella RP as Therapy for COVID-19 Patients with Right Heart Failure
The United States Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Impella RP to include patients suffering from COVID-19 related right heart failure or decompensation, including pulmonary embolism (PE). Abiomed (NASDAQ: ABMD) manufactures Impella RP. Impella RP is a temporary heart pump that provides circulatory support for patients who develop right side ventricular failure.…
Read MoreSenseonics Launches New Remote Monitoring App for Android Users in US
Senseonics Holdings, Inc. a medical technology company focused on the development and commercialization of the first and only long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today announced the launch of Eversense® NOW Remote Monitoring App for Android Operating System. “Now more than ever, the world relies upon remote methods of contact…
Read MoreAIROS Medical Launches New Compression Therapy Device and Garment System to Treat Breast Cancer Patients
AIROS® Medical, Inc., a medical technology manufacturer specializing in compression therapy products that treat cancer-related lymphedema and venous complications, today announced the launch of its updated AIROS 6 Sequential Compression Therapy device and Arm Plus garments following multiple regulatory approvals. AIROS received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its updated AIROS…
Read MoreGynesonics Receives FDA Clearance to Market Next Generation Sonata System 2.1
Gynesonics, a women’s healthcare company focused on the development of minimally-invasive solutions for symptomatic uterine fibroids, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its next generation Sonata® System 2.1 for Transcervical Fibroid Ablation (TFA). The Sonata technology platform integrates the first and only intrauterine…
Read MoreNeovasc Has Filed for CE Mark for Tiara TA Transapical Mitral Valve Replacement System
Neovasc, Inc., a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, and minimally invasive devices for the treatment of refractory angina, today announced that the Company has filed for CE Mark for its Tiara TA Transapical mitral valve replacement system. Mitral Valve disease is one of the most common forms of…
Read MoreCentinel Spine Announces FDA Approval for the Manufacturing Transfer of prodisc Technology
Centinel Spine, LLC, the largest privately-held spine company focused on anterior column reconstruction, today announced FDA approval for the manufacturing transfer of both the prodisc® C Cervical Total Disc Replacement and prodisc® L Lumbar Total Disc Replacement systems to new strategic vendors. The FDA approval for manufacturing transfer is a critical milestone for Centinel Spine as it allows the…
Read MoreSTERIS Announces Second On-site Decontamination Solution for Respiratory Masks
STERIS plc announced that the U.S. Food and Drug Administration (FDA) has issued another Emergency Use Authorization (EUA) for respirator decontamination. The EUA enables healthcare providers to decontaminate surgical N95 respirators by utilizing certain AMSCO Steam Sterilizers that have been upgraded with STERIS’s new “Decon” cycle. This EUA is the second authorization for STERIS to…
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