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April 2, 2024
ONWARD Medical has submitted its De Novo application to the US Food and Drug Administration (FDA) to allow marketing of its breakthrough ARC-EX System. ...
April 2, 2024
FDA clearance would allow the Company to market its breakthrough therapy to improve or restore hand and arm function after spinal cord injury in the USTHIS PRESS RELEASE CONTAINS INSIDE INFORMATION...
March 27, 2024
Elixir Medical has announced it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its DynamX BTK System, a novel, adaptive implant for use in the treatment of narrowed or blocked vessels below-the-knee (BTK) in patients with chronic limb-threatening ischemia (CLTI). The company reports this broadens the use of the novel bioadaptor platform technology beyond the treatment of coronary artery disease.
March 11, 2024
The Company is one of the first brain-computer interface entrants accepted into this program, intended to optimize the commercialization pathway for breakthrough medical technology EINDHOVEN, the...
January 22, 2024
WASHINGTON , Jan. 22, 2024 /PRNewswire/ -- MCRA, LLC, a leading medical device and biologics focused clinical research organization and advisory firm integrating seven core services [U.S. and...
January 2, 2024
Better Therapeutics, Inc. , a pioneer in developing prescription digital therapeutics to treat cardiometabolic diseases, today announced it has submitted a request to the U.S. Food and Drug...
December 28, 2023
PRINCETON, N.J., Dec. 28, 2023 -- CytoSorbents Corporation , a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its...
December 28, 2023
CytoSorbents Corporation announced an update on the initial data analysis of primary safety and effectiveness endpoints and the final independent Data and Safety Monitoring Board analysis for the...
December 22, 2023
TORONTO, Dec. 22, 2023 /CNW/ - Symetryx Corporation , a Canadian venture company, is pleased to announce that the shareholders of Check-Cap Ltd. voted overwhelmingly to elect all the director...
December 21, 2023
NAUTILUS is the first and only pivotal clinical study to evaluate neuromodulation therapy for treating drug refractory idiopathic generalized epilepsy Neuromodulation therapy is not currently...