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Diagnostics & Healthcare News
Nuvaira Announces FDA Breakthrough Designation for AIRFLOW-3 Pivotal Trial Device
Nuvaira, a developer of novel therapeutic strategies to treat obstructive lung diseases, has announced that its Nuvaira® Lung Denervation System has been designated as a Breakthrough Device by the U.S. Food and Drug Administration (FDA).  This program creates an expedited...
June 8, 2020
Cardiovascular / Cardiology
VasQ External Support Awarded Breakthrough Device Designation by the FDA
The FDA has designated Laminate Medical’s VasQ™ External Support for the creation of arteriovenous fistulas (AVF) in hemodialysis patients as a Breakthrough Device. The FDA Breakthrough Device Program is intended to provide patients and doctors timely access to medical devices...
June 8, 2020
Cardiovascular / Cardiology
FDA Clears Innovative Angioplasty Scoring and Cutting Platform
Transit Scientific announced the FDA cleared the XO Score® Percutaneous Transluminal Angioplasty (PTA) Scoring Sheath platform for use in iliac, ilio-femoral, popliteal, infra-popliteal, and renal arterial plus synthetic and/or native arteriovenous hemodialysis fistula. Angioplasty is performed with expandable polymer balloon catheters...
June 4, 2020
Surgery and Surgical Robotics
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...
June 4, 2020
Diagnostics & Healthcare News
Noctrix 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...
June 3, 2020
Cardiovascular / Cardiology
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...
June 3, 2020
Surgery and Surgical Robotics
3NT 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...
June 2, 2020
Imaging Visualization & Navigation
Arterys 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...
June 2, 2020
Cardiovascular / Cardiology
FDA 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...
June 1, 2020
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