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Tag: Food and Drug Administration

AI Triage Solution for Deadly Vascular Conditions Receives FDA Clearance and CE Mark

June 3, 2021 — Medical imaging AI specialist Avicenna.AI announced that it has received certification in the United States and European Union for Cina Chest, its new...

FDA Alerts Health Care Providers to Stop New Implants of Certain Ventricular Assist Device System

The U.S. Food and Drug Administration is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic’s Heartware Ventricular Assist...

HVAD System: Medtronic to Stop Distribution and Sale

Medtronic plc (NYSE:MDT), the global leader in medical technology, is stopping the distribution and sale of the Medtronic HVAD™ System.HVAD System: This morning,...

Medtronic Gains FDA Clearance of UNiD™ Patient-Specific Rods for Use with CD Horizon™ Solera™ Voyager™ and Infinity™ OCT Spinal Systems

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the U.S. Food and Drug Administration (FDA) clearance of patient-specific UNiD™ Rods...

PURA Publishes Farmersville Hemp Brand Transition Preview

DALLAS, TX, June 3, 2021 – Puration, Inc. (OTC Pink: PURA) today released a management preview of its transition strategy to complete its fulltime, singularly...

Senseonics Announces Results of the PROMISE Study Demonstrating Strong Accuracy of 180 Day CGM Sensor

GERMANTOWN, Md.--(BUSINESS WIRE)-- Senseonics Holdings, Inc. (NYSE-American: SENS), a medical technology company focused on the development and commercialization of the first and only...

PURA ALKM USMJ and PAOG Strategic Transition Preview Tomorrow

DALLAS, TX, June 2, 2021 – Puration, Inc. (OTC Pink: PURA) today confirmed that tomorrow, Thursday, June 3rd, the company will preview its transition...

NANOBIOTIX Announces the Appointment of Bart Van Rhijn as Chief Financial Officer and Member of the Executive Board to Support Global Expansion

PARIS & CAMBRIDGE, Mass.–(BUSINESS WIRE)–$NBTX #NBTXNews–Regulatory News: NANOBIOTIX (Euronext : NANO – NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering...

Clinical Trial Evaluating Mixed COVID-19 Vaccine Schedules Begins

The National Institutes of Health has started a Phase 1/2 clinical trial in which adult volunteers who have been fully vaccinated against...

Abiomed Acquires preCARDIA

Abiomed (NASDAQ: ABMD) has acquired preCARDIA, developer of a proprietary catheter and controller that will complement Abiomed’s product portfolio to expand options for...

Paragon 28 Acquires the Assets of Additive Orthopaedics

Paragon 28, Inc., a market-leading orthopedic medical device company focused exclusively on the foot-and-ankle, today announced that the Company has acquired the product...

BrainsWay Announces First Draft Proposal for OCD Coverage by a Regional Medicare Administrative Contractor

Palmetto GBA, Administrator of Medicare in Seven States, Publishes Draft Local Coverage Determination CRESSKILL, N.J. and JERUSALEM, Israel, June 01, 2021 (GLOBE NEWSWIRE)...

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