AHF Lauds WHO’s Belated Pre-Qualification of the Ebola Vaccine

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After more than four years of testing and vaccinations under compassionate use protocols, the most effective Ebola vaccine has at last received World Health Organization (WHO) pre-qualification, clearing regulatory hurdles for its wide-scale use. “AHF has been calling for an approved vaccine for more than a year—even before the current outbreak in the DRC (Democratic Republic of…

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Edwards Lifesciences gets approval for SAPIEN 3 TAVI valve in Europe

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Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has received CE Mark to expand use of the Edwards SAPIEN 3 transcatheter heart valve for the treatment of patients diagnosed with aortic stenosis who are at low risk for open-heart surgery.…

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Cleveland Clinic First in the World to Perform Robotic Single-Port Kidney Transplant 

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Cleveland Clinic is the first hospital in the world to successfully perform a robotic single-port kidney transplant, which enables all surgical instruments and the donor kidney to be placed through one small abdominal incision. The Glickman Urological & Kidney Institute surgical team included Jihad Kaouk, M.D., director of the Center for Robotic and Image Guided…

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Formlabs Launches New Dental Business Unit, Formlabs Dental, With Form 3B and New Materials Designed to Meet the Demands of the Dental Industry

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Formlabs, the designer and manufacturer of powerful and accessible 3D printing systems, has today announced it is strengthening its commitment to the dental market. According to a Key Group survey, Formlabs is the most installed 3D printer for small, medium and large sized dental labs. Formlabs Dental, the company’s newly announced dental business unit, is made up of…

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Abbott Announces Robert B. Ford to Succeed Miles D. White as Chief Executive Officer on March 31, 2020 

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Abbott announced that Miles D. White will be stepping down as Chief Executive Officer on March 31, 2020, after a remarkable 21-year tenure, the second longest for a non-founder in today’s S&P 100. He will remain Executive Chairman of the Board. The Board has unanimously appointed Robert B. Ford, a 23-year Abbott veteran, to succeed Mr. White as…

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Nevro’s Senza Omnia Spinal Cord Neurostimulation System Gains FDA Approval

Nevro Corp. (NYSE: NVRO), a global medical device company that provides innovative, evidence-based solutions for the treatment of chronic pain, today announced it has received approval from the U.S. Food and Drug Administration (FDA) for the Senza® Omnia™ Spinal Cord Stimulation (SCS) System. The Omnia system is the first and only SCS system designed to deliver Nevro’s…

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Sonde Health Granted Foundational U.S. Patent for Use of Vocal Biomarkers in Health Assessments

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Sonde Health, Inc., a leading company developing a voice-based technology platform to measure health when a person speaks, today announced that the United States Patent and Trademark Office issued U.S. Patent No. 10,475,530, a foundational patent that covers crucial aspects of Sonde’s vocal biomarker technology. The patent covers the use of Sonde’s technology to capture,…

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Conformis Announces FDA Clearance and Full Commercial Launch of Next Generation Hip System 

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Conformis, Inc. (NASDAQ:CFMS), a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture, and sell patient-specific arthroplasty joint replacement implants designed to fit each patient’s unique anatomy, today announced FDA clearance of the Company’s next generation Conformis Hip System. The Company will be featuring the new 3D-designed Conformis Hip System as…

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Airflow Sleep, a Sleep Solutions and Advocacy Company, Launches to Fight the Sleep Epidemic 

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Airflow Sleep, a total sleep solutions and advocacy company that empowers people to improve sleep quality and behavior, exited stealth mode today as it prepares to launch its ZO2 Sleep System for the consumer market. Each system contains a physician-designed, patented side or back sleeper pillow supporting all types of sleepers, an advanced sleep tracking…

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Omega Medical Imaging First in the World to Receive FDA Clearance on Artificial Intelligence Imaging System that Reduces Radiation Exposure

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Omega Medical Imaging, manufactures of Artificial Intelligence Fluoroscopy/Cine (AIF/C) Imaging systems, just announced the Food and Drug Administration 510 (k) clearance of FluoroShield™ with their 2020 Cardiac Flat Panel Detector. The unique FluoroShield™ system allows for auto collimation during interventional fluoro or cine cases while maintaining a perspective of surrounding anatomy. The blended image incorporates a lower…

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