Posts by cstephenson@legacymedsearch.com
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 in which Flow Forward merged with and into Artio was approved by the Board of…
Read MoreAmbu 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 through innovative design of single-use devices, and we are excited to improve safety for the…
Read MoreFDA 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 bleeding in the office setting. Originally approved by the FDA in March 2019, Channel’s Cerene Device uses…
Read MoreLifeSignals 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 collection of Electrocardiography (ECG) and Heart Rate monitoring in ambulatory, hospital, home and healthcare settings.…
Read MoreFX 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 humeral heads and glenospheres that we offer but with the TiN coating applied. The TiN coated…
Read MoreMayo 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 a 3-D holographic view of the patient’s pre-operative plan. Robert Palmisano, president and chief executive…
Read More7D 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 the European market and additional global regions. The 7D Surgical MvIGS System is the only…
Read MoreMedtronic to Acquire Medicrea
Medtronic plc (NYSE:MDT), a global leader in medical technology, and Medicrea, a pioneer in the transformation of spinal surgery through artificial intelligence, predictive modeling and patient specific implants, today announced that they have entered into a tender offer agreement for the acquisition of all outstanding shares of Medicrea. The friendly voluntary all-cash tender offer will…
Read MoreINSIGHTEC wins Medicare Coverage for MR-Guided Focused Ultrasound Platform
INSIGHTEC, a global medical technology innovator of incisionless surgery, announced today achievement of complete Medicare coverage across all 50 states for MR-guided focused ultrasound treatment of medication-refractory Essential Tremor. “INSIGHTEC is committed to expanding patient access for MR-guided focused ultrasound,” said Dee Kolanek, INSIGHTEC Vice President of Reimbursement. “The efforts of our team have made complete…
Read MoreFDA Green-lights Infervision’s Deep Learning Tool for Segmenting Lung CT Scans
Infervision is pleased to announce the U.S. Food and Drug Administration (FDA) 510(K) clearance of the InferRead Lung CT.AI product, which uses the state-of-the-art artificial intelligence and deep learning technology to automatically perform lung segmentation, along with accurately identifying and labeling nodules of different types. InferRead Lung CT.AI is designed to support concurrent reading and…
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