medical device guru

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
Cardiovascular / Cardiology
Rapid Medical Receives CE Mark for Stentriever
Rapid Medical, a company focused on the development of next generation neurovascular devices, has announced that it received CE Mark for TIGERTRIEVER XL. In addition, the first patients have been treated successfully with the device. The TIGERTRIEVER family of stentrievers...
July 27, 2020
Cardiovascular / Cardiology
Artio Medical Acquires Flow Forward Medical, Expanding Peripheral Vascular Portfolio
Artio Medical, Inc. (Artio) today announced it has acquired Flow Forward Medical, Inc. (Flow Forward), a medical device company developing innovative methods for establishing and maintaining high-quality vascular access sites to improve outcomes for hemodialysis patients. This stock-for-stock merger transaction...
July 24, 2020
Surgery and Surgical Robotics
Ambu Wins FDA Clearance for Single-use Duodenoscope Product
Ambu Inc., a rapidly growing medical device maker and pioneer of sterile, single-use endoscopes, announced today that the Ambu® aScope™ Duodeno has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). “At Ambu, we are determined to advance patient safety...
July 23, 2020
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