medical device guru

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
Diagnostics & Healthcare News
AdvaMed Commends Proposed CMS Rule to Cover “Breakthrough” Medical Devices
Following today’s issuance by the Centers for Medicare and Medicaid Services (CMS) of a proposed rule on Medicare coverage of innovative technologies, the Advanced Medical Technology Association (AdvaMed) issued the following statements from President and CEO Scott Whitaker and other...
September 1, 2020
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