Posts by rw-admin
Titan Medical Announces Development and License Agreements With Medtronic and Senior Secured Loan
Titan Medical Inc. (“Titan” or “Titan Medical”) (TSX: TMD) (Nasdaq: TMDI), a medical device company focused on the design and development of single-port robotic surgical technologies, announces that it has entered into a development and license agreement with Medtronic plc (“Medtronic”) (NYSE: MDT) to further the development of robotic assisted surgical technologies, as well as…
Read MoreNoctrix Health granted FDA Breakthrough Device Designation for wearable Restless Legs Syndrome Therapy
Noctrix Health, Inc., a privately held medical device company announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its wearable NTX100 Neuromodulation therapy designed for the treatment of adults with primary moderate-severe Restless Legs Syndrome (RLS) who are refractory to medications. RLS is the second most common sleep disorder in…
Read MoreAesculap 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…
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