medical device guru

Cardiovascular / Cardiology
Access Vascular Inc. Secures $20 Million in Series B Financing
Access Vascular, Inc., a company addressing the most common and costly venous access complications, today announced it has closed on a Series B round of financing. TVM Capital Life Science led the round with a $15 million commitment, with existing...
March 14, 2021
Cardiovascular / Cardiology
Shockwave Intravascular Lithotripsy FDA Approved to Treat Advanced Heart Disease
Shockwave Medical, Inc., a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced last month that the company’s sonic pressure wave therapy received Pre-Market Approval for severely calcified coronary artery disease from the U.S....
March 7, 2021
Surgery and Surgical Robotics
FDA Grants Breakthrough Device Designation for Anuncia’s Cerebral Spinal Fluid Treatment
Anuncia Inc., an emerging leader in Cerebral Spinal Fluid (CSF) management, received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its ReFlow™ System Mini intended for the treatment of CSF disorders requiring shunting such as hydrocephalus, a debilitating and...
March 7, 2021
Orthopedics and Spine
NuVasive Acquires Simplify Medical
NuVasive, Inc., the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced that it has acquired Simplify Medical, a privately held company and developer of the Simplify® Cervical Artificial Disc (Simplify Disc)...
February 28, 2021
Diagnostics & Healthcare News
OpSens Announces Closing of $28.75 Million Bought Deal Public Offering Including $3.75 Million Over-Allotment Option Exercised in Full
OpSens Inc. (“OpSens” or the “Company”) (TSX:OPS) (OTCQX:OPSSF) announced last week the closing of its previously announced bought deal public offering (the “Offering”) of common shares of the Company (the “Common Shares”), for total gross proceeds of approximately $28,750,000. The Company...
February 28, 2021
Surgery and Surgical Robotics
Fusion Robotics Wins FDA Clearance for 3D Imaging Robotic Targeting System
Fusion Robotics LLC, a spinal robotics and navigation company today announced receiving 510(k) clearance to market their 3D imaging compatible navigation and robotic targeting system for spine surgery in the U.S. market. The Fusion Robotics System addresses the key limitations...
February 28, 2021
Diagnostics & Healthcare News
FDA clears Signifier Medical’s Electric Tongue Muscle Strengthener to Treat Sleep Apnea and Snoring
The FDA has approved eXciteOSA, the revolutionary first-ever daytime treatment for mild obstructive sleep apnea and snoring. Used for only 20 minutes per day for a period of six weeks and then twice per week, the therapy is clinically proven...
February 21, 2021
Cardiovascular / Cardiology
Implicity Rolls Out AI-Empowered Remote Cardiac Monitoring to Over 10,000 Patients
Implicity, the leading remote cardiac monitoring company in Europe, officially announced its rollout into the US market via its partnership with the Phoenix-based company, IronRod Health. Implicity and IronRod have been nominated for The Prix Galien Medstartup USA in the...
February 21, 2021
Cardiovascular / Cardiology
Vascular Perfusion Solutions Lands FDA Breakthrough Designation for Organ-Transport Device
The U.S. Food and Drug Administration (FDA) has granted Vascular Perfusion Solutions, Inc. (VPS) a Breakthrough Device Designation for its groundbreaking VP.S Encore™ oxygenated perfusion cardiac transport device. The patent-pending technology uses oxygen to enable preserving vascularized tissue for eight...
February 14, 2021
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