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Orthopedics and Spine

Spineology Gets FDA De Novo Grant of Minimally Invasive OptiMesh Expandable Interbody Fusion System

Spineology Inc., an innovator in anatomy-conserving surgery, is excited to announce the FDA grant of its proprietary Spineology Interbody Fusion System, now called the OptiMesh Expandable Interbody Fusion System. The grant follows the successful completion of the SCOUT (Spineology Clinical...

September 22, 2020

Orthopedics and Spine

Cerapedics Announces Canadian Approval of its Next-generation Bone Graft

Cerapedics, a private ortho-biologics company, today announced the Health Canada approval of the company’s next-generation bone graft called i-FACTOR+ Matrix, making it the first market to approve the commercial launch of this product. “We are excited to announce Canadian regulatory...

September 17, 2020

Surgery and Surgical Robotics

Intersect ENT Announces Agreement to Acquire Fiagon for $71M

Intersect ENT, Inc., a company transforming care for patients with ear, nose and throat (“ENT”) conditions, today announced it has entered into an agreement to acquire Fiagon AG Medical Technologies, a leader in electromagnetic surgical navigation solutions, for €60 million in...

September 15, 2020

Diagnostics & Healthcare News

Fitbit Wins FDA 510(k) Clearance and CE Mark for ECG App

Fitbit has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as Conformité Européenne (CE)marking in the European Union, for its electrocardiogram (ECG) app to assess heart rhythm for atrial fibrillation (AFib), a condition that affects more than...

September 14, 2020

Cardiovascular / Cardiology

Avinger Receives FDA Clearance of Ocelaris Next Generation Image-guided CTO Crossing System

Avinger, Inc., a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of patients with Peripheral Artery Disease (PAD), today announced that the Company received 510(k) clearance from the U.S. Food &...

September 11, 2020

Surgery and Surgical Robotics

Minnetronix Medical Wins FDA Clearance for Innovative Neurosurgical Access Platform

Minnetronix Medical, the company known for 25 years of developing and manufacturing products for medical device companies throughout the world, today announced that it has received FDA clearance for its first platform product: the MindsEye™ Expandable Port for neurosurgical procedures....

September 10, 2020

Cardiovascular / Cardiology

Medtronic Tricuspid Valve Replacement Device Wins FDA Breakthrough Status

Medtronic, a global leader in structural heart therapies, today announced U.S. Food and Drug Administration (FDA) approval of an early feasibility study (EFS) of the Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) system in patients with severe, symptomatic tricuspid regurgitation, a...

September 9, 2020

Imaging Visualization & Navigation

Fujifilm Sonosite Receives FDA COVID-19 510(k) Clearance for Point-of-Care Ultrasound Portfolio

FUJIFILM Sonosite, Inc., specialists in developing cutting-edge point-of-care ultrasound (POCUS) solutions, and part of the larger Fujifilm Healthcare portfolio, today announced that the company has received 510(k) Clearance from the U.S. Food & Drug Administration (FDA) for the company’s entire POCUS portfolio...

September 8, 2020

Cardiovascular / Cardiology

CryoLife Acquires Ascyrus Medical

CryoLife, Inc., a leading cardiac and vascular surgery company focused on aortic disease, announced today that it has acquired Ascyrus Medical LLC.  Ascyrus is a Florida-based, privately-held developer of the Ascyrus Medical Dissection Stent, the world’s first aortic arch remodeling...

September 3, 2020