medical device guru

Cardiovascular / Cardiology
RapidAI Receives FDA Clearance of Rapid LVO For Identification of Suspected Large Vessel Occlusions
RapidAI, the worldwide leader in advanced imaging for stroke, today announced that Rapid LVO has received Food and Drug Administration (FDA) clearance for detecting suspected LVOs (Large Vessel Occlusions). Rapid LVO helps physicians speed up triage or transfer decision-making. Working...
August 13, 2020
Diagnostics & Healthcare News
Neurolief Wins FDA Breakthrough Device Designation for Wearable Neuromod for Depression
Neurolief, a medical neurotechnology innovator, today announces that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to the Relivion system, the first non-invasive multi-channel brain neuromodulation technology, for the treatment of major depression. A wearable device,...
August 11, 2020
Diagnostics & Healthcare News
eSight 4 Earns CE Mark Approval to Bring New Wearable Device to Europe
eSight, a cutting-edge vision enhancement platform, today announces it has received CE Mark approval for eSight 4, the company’s latest assistive technology device that’s clinically proven to significantly enhance vision for those living with low vision and legal blindness. The...
August 10, 2020
Orthopedics and Spine
FDA Clears Life Spine Anterior Lumbar Spacer System
Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the PLATEAU-A Ti...
August 6, 2020
Cardiovascular / Cardiology
Eko and AstraZeneca Announce Digital Cardiovascular Health Partnership
Eko today announced a global collaboration with AstraZeneca to accelerate the development of digital health tools for the earlier screening of cardiovascular diseases, including heart failure. “There are millions of people living with or at risk for heart failure. AstraZeneca’s...
August 5, 2020
Imaging Visualization & Navigation
Siemens Healthineers to buy Varian Medical Systems for $16.4 billion
Varian today announced that it has entered into a definitive agreement to combine with Siemens Healthineers AG in an all-cash transaction valued at $16.4 billion on a fully diluted basis. Under the terms of the agreement, which has been unanimously...
August 3, 2020
Surgery and Surgical Robotics
U.S. FDA Grants Ethicon Breakthrough Device Designation for Monarch-enabled NeuWave Microwave Ablation Technology
Ethicon, part of the Johnson & Johnson Medical Devices Company, announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for transbronchial microwave ablation technology using robotic-assisted bronchoscopy, which is currently under development. The Breakthrough Devices Program...
July 31, 2020
Diagnostics & Healthcare News
Philips Wins FDA Clearance for EMS Remote Monitoring and Defibrillation Solution
Royal Philips, a global leader in health technology, today announced the launch of its remote monitoring and defibrillator solution (Tempus ALS) for pre-hospital settings in the U.S. The solution is a complete end-to-end system that combines innovative hardware and advanced...
July 30, 2020
Imaging Visualization & Navigation
FDA Clears Zebra Medical’s Breast Cancer AI for Spotting Suspicious Mammography Lesions
Zebra Medical Vision, the deep-learning medical imaging analytics company, announces today its sixth FDA 510(k) clearance for its mammography solution, HealthMammo, which has already received a CE mark. Zebra Medical’s algorithm empowers breast radiologists by prioritizing and identifying suspicious mammograms,...
July 28, 2020
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