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Cardiovascular / Cardiology
TransMedics Receives FDA Clearance of OCS Lung Solution for Cold Preservation of Lungs
TransMedics Group, Inc. (“TransMedics”), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its OCS™ Lung Solution for use...
August 1, 2021
Cardiovascular / Cardiology
CARMAT Announces the First Human Implant of its Total Artificial Heart in the United States
CARMAT, the designer and developer of the total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, announces the first implantation of its bioprosthetic artificial heart, Aeson,...
July 18, 2021
Diagnostics & Healthcare News
Dexcom Wins FDA Nod for Real-time APIs, Allowing Third-party Developers Access to CGM Data
Dexcom’s Partner Web Application Programming Interfaces (APIs) were cleared by the FDA, allowing approved third-party developers to connect to the continuous glucose monitoring data of Dexcom users. Developers can integrate CGM data with their applications, diabetes management systems or devices through...
July 18, 2021
Surgery and Surgical Robotics
Neuros Medical Receives FDA Breakthrough Device Designation for its Novel Altius High Frequency Nerve Block System
Neuros Medical, Inc., announced today that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel High-Frequency Nerve Block system as an aid in the management of chronic intractable pain...
July 5, 2021
Surgery and Surgical Robotics
Interventional Systems Receives FDA Clearance for Miniature Surgical Robot for Needle-based Procedures
Interventional Systems announced Micromate, the world’s smallest robot for percutaneous procedures, received its FDA 510(k) clearance, allowing the robotics company to operate in the USA. Micromate is a table-mounted medical robot for interventional procedures with a universal instrument guidance solution that...
July 5, 2021
Imaging Visualization & Navigation
Latest iCad 3D Mammography AI Gains CE Mark
iCAD, Inc., a global medical technology leader providing innovative cancer detection and therapy solutions, today announced that ProFound AI® Version 3.0 for Digital Breast Tomosynthesis (DBT) received CE Mark approval. Compared to previous software versions, the latest generation of ProFound AI...
June 20, 2021
Orthopedics and Spine
Spino Modulation Vertebral Body Tethering Device Wins FDA Breakthrough Device Designation
Spino Modulation Inc., a subsidiary of Spinologics Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for its MIScoli™ system, an innovative vertebral body tethering (VBT) device to treat scoliosis in...
June 20, 2021
Diagnostics & Healthcare News
Cognoa Receives FDA Marketing Authorization for First-of-its-kind Autism Diagnosis Aid
Cognoa, a pediatric behavioral health company developing diagnostic and therapeutic solutions for children living with behavioral health conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted the company’s De Novo classification request for its autism diagnosis...
June 6, 2021
Cardiovascular / Cardiology
AliveCor Purchases CardioLabs
AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology and services, today announced that it has acquired the independent diagnostic testing facility (IDTF) CardioLabs, a leading monitoring and cardiac diagnostic service provider. The acquisition is a cornerstone of AliveCor’s...
June 6, 2021
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