WASHINGTON, July 26 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has classified an active noise attenuation system for infant incubators as a Class II medical device subject to special controls, determining the requirements provide reasonable assurance of safety and effectiveness. The final order is effective July 27, 2026, while the classification was applicable June 16, 2023, when FDA issued an order following a De Novo request from Invictus Medical  more

WASHINGTON, July 26 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has classified a non-medicated topical formulation for treatment of erectile dysfunction as a Class II medical device subject to special controls, establishing requirements intended to provide reasonable assurance of safety and effectiveness. The order, effective July 27, 2026, codifies a classification that FDA applied June 9, 2023, following a De Novo request from Futura Medical Develo  more

WASHINGTON, July 27 -- The Federal Reserve Bank of Boston issued the following Beige Book on July 15, 2026: * * * Summary of Economic Activity Economic activity continued to expand at a slight pace. Consumer spending rose modestly, supported by the World Cup soccer tournament, but many consumers showed heightened price sensitivity. Manufacturing activity grew slightly, with strong demand from defense and automation. Bank loan volume ticked up, as did nonfinancial services activity. Real estat  more