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HistoSonics www.histosonics.com the manufacturer of the Edison System and novel histotripsy therapy platforms announced today that the companys Edison System has been selected to participate in the UKs newly created Innovative Devices Access Pathway IDAP Pilot Program designed to accelerate the development of costeffective medical devices and their integration into the UK market.
MINNEAPOLIS--(BUSINESS WIRE)--Feb 14, 2024--
HistoSonics www.histosonics.com the manufacturer of the Edison System and novel histotripsy therapy platforms announced today the marketing authorization of its Breakthrough platform via the U.S. Food and Drug Administrations FDA De Novo Classification Request process a rigorous premarket review pathway for medical devices with no existing predicate.