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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.

United kingdomEngineering centerUnited statesCraig hospitalNoord hollandAditi royKhaled bahiWorld health organization fact sheetLausanne university hospitalDrug administrationVp communicationsNeither the companySwiss federal institute of technologyCandy tefertillerExecutive directorDevice designation

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.

Motasim sirhanDrug administrationElixir medicalBreakthrough device designationDynamx bioadaptorDevice designationUnited kingdom

PhotoPharmics Launches Largest Phototherapy Trial for Parkinson s Disease

PhotoPharmics Launches Largest Phototherapy Trial for Parkinson s Disease
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Brett walkerDan adamsPerez lloretRay dorseyRay chaudhuriMovement disorders societyMovement disorders society evidenceTechnology cheUniversity of rochesterUniversity of rochester medical centerMotor symptoms study groupMedicine committeeMovement disordersPivotal trialImproving overall functionRochester medical center

Finland s Sooma nets €5M to expand access to at-home depression treatment

Finland s Sooma nets €5M to expand access to at-home depression treatment
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Eteläuomen läiInka meroTuomas neuvonenStephen industriesVerge healthtech fundVoima venturesSingapore based verge healthtech fundTranscranial direct current stimulationDevice regulationFounding partnerDevice designation

ONWARD Medical NV: ONWARD® Medical Accepted to New US FDA TAP Program for Development of its ARC-BCI System

ONWARD Medical NV: ONWARD® Medical Accepted to New US FDA TAP Program for Development of its ARC-BCI System
finanznachrichten.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from finanznachrichten.de Daily Mail and Mail on Sunday newspapers.

Noord hollandUnited statesAditi royStefan klotterKhaled bahiLausanne university hospitalDrug administrationVp communicationsEngineering centerNeither the companyProduct lifecycle advisory programSwiss federal institute of technologyTotal product lifecycle advisory programDevice designationBreakthrough device designationsSwiss federal institute