FDA Grants Breakthrough Status to SonoClear for Intracranial Ultrasound
Designed to reduce imaging artifacts during neurosurgery, the SonoClear System now has FDA Breakthrough Device status and is moving toward 510(k) submission.
Tag: FDA Breakthrough Device Designation
All
Latest
All
Latest
FDA Grants J-Valve TF System Breakthrough Device Designation
Genesis MedTech announced that its J-Valve Transfemoral (TF) System has been granted Breakthrough Device designation by the FDA.
All
Latest
New PTSD Treatment Gets FDA Breakthrough Device Designation
A pilot study for a new PTSD therapeutic device supports its recent Breakthrough Device designation from the FDA.
All
Latest
FDA Grants Breakthrough Status to SonoClear for Intracranial Ultrasound
Designed to reduce imaging artifacts during neurosurgery, the SonoClear System now has FDA Breakthrough Device status and is moving toward 510(k) submission.
U.S. FDA Grants Breakthrough Device Designation for EndoSound Vision Ultrasound System
The EndoSound Vision System is an add-on device that consists of a compact ultrasound beam-former, reusable transducer, and disposable mounting kit that fastens onto any flexible upper gastrointestinal video endoscope to convert it into an endoscopic ultrasound system.
Read More
FDA Grants Breakthrough Designation to Synapse Biomedical’s TransAeris System
Ohio-based Synapse Biomedical, Inc. announces that the U.S. FDA has granted Breakthrough Therapy Device designation to TransAeris, a temporary percutaneous intramuscular diaphragm stimulator designed to aid in weaning from mechanical ventilation.
Read More
Endologix ChEVAS System Gets FDA Breakthrough Device Designation
The ChEVAS System is an investigational endovascular abdominal aortic aneurysm (AAA) sealing therapy designed to combine the Nellix 3.5 endograft with parallel visceral stents to enable treatment of patients with juxtarenal, pararenal, and suprarenal AAA.
Read More
Sensome AI-Powered Stroke Guidewire Gets FDA Breakthrough Device Designation
Sensome has been granted a Breakthrough Device designation by the FDA for its Clotild Smart Guidewire System designed to improve the treatment of ischemic stroke patients.
Read More
VoluMetrix’s NIVA|HF for Heart Failure Patients Designated as FDA Breakthrough Device
NIVA|HF is an investigational device designed to monitor the venous waveform in heart failure patients using VoluMetrix’s Non-Invasive Venous waveform Analysis (NIVA) technology.
Read More
FDA Grants Breakthrough Device Designation for Smart Orthopedic Implants
Intelligent Implants SmartFuse technology is a wirelessly enabled orthopedics platform that has been designed to remotely stimulate, control, and monitor bone growth.
Read More
All
Latest
IceCure Medical Granted FDA Breakthrough Device Designation for ProSense Cryoablation System
The U.S. FDA has granted cryoablation technology developer IceCure Medical Ltd. Designation as a Breakthrough Device for its lead product, ProSense, and proposed indication for use, including for use in the treatment of patients with T1 invasive breast cancer.