ONWARD® Medical Submits De Novo Application to FDA for its
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. ...
Source: globenewswire.com
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ONWARD® Medical Submits De Novo Application to FDA for its ARC-EX® System
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...
Source: marketscreener.com
Elixir Medical Receives FDA Breakthrough Device Designation for DynamX BTK System for Below-The-Knee Arterial Disease
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.
Source: dicardiology.com
ONWARD® Medical Accepted to New US FDA TAP Program for Development of its ARC-BCI™ System
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...
Source: marketscreener.com
MCRA Provides Anzu Special Acquisition Corp I with Strategic Diligence Support Leading to Envoy Medical Merger (NASDAQ: COCH) -January 22, 2024 at 09:31 am EST
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...
Source: marketscreener.com