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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
Surgery and Surgical Robotics
FDA Approves Channel Medsystems’ Women’s Health Cryotherapy Device
Channel Medsystems, a company dedicated to bringing innovation to the delivery of women’s healthcare, today announced that the U.S. Food and Drug Administration (FDA) recently approved the newest Cerene Cryotherapy Device, a next-generation technology for the treatment of heavy menstrual...
July 22, 2020
Diagnostics & Healthcare News
LifeSignals Wireless Medical Biosensor Receives FDA Clearance
LifeSignals Group, today announced USFDA 510(k) clearance has been received for their LifeSignals ECG Remote Monitoring Patch Platform. The LifeSignals ECG Remote Monitoring Patch Platform is a wireless remote monitoring system intended for use by healthcare professionals for the continuous...
July 21, 2020
Orthopedics and Spine
FX Solutions Receives FDA 510k Clearances for Titanium Nitride Coated Humeral Heads and Glenospheres
FX received 510k clearances for their TiN (Titanium Nitride) Coated Humeral Heads and Glenospheres. The new addition of TiN coated humeral heads and glenospheres adds unique-to-market prostheses to the FX portfolio. The TiN coated humeral heads and glenospheres are identical to the current...
July 20, 2020
Orthopedics and Spine
Mayo Clinic performs first shoulder arthroplasty with Wright Medical mixed reality tech
Wright Medical Group N.V. (NASDAQ: WMGI) today announced that the first shoulder arthroplasty procedure was performed using groundbreaking BLUEPRINT Mixed Reality Technology at Mayo Clinic’s campus in Rochester, Minnesota.  Joaquin Sanchez-Sotelo, M.D., Ph.D, performed the procedure utilizing BLUEPRINT OR Visualization Mixed Reality software, which provides...
July 17, 2020
Imaging Visualization & Navigation
7D Surgical Wins CE Mark Certification for Machine Vision Image Guided Spine Surgery
7D Surgical announced today that it has achieved CE Mark certification for its innovative Machine-vision Image Guided Surgery (MvIGS) system for spine surgery. This achievement clears the way for 7D Surgical to commence commercialization efforts of its spinal platform across...
July 16, 2020
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