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The FDA sent a Warning Letter to RoyalVibe Health for unapproved ultrasound technology devices the company has not removed from the market and for continuing to market the products online.
The proposed European Artificial Intelligence Act (AIA) will impose an additional burden on the already limited number of notified bodies, resulting in delays in the marketing of new medical devices and technologies, the European Association of Medical Devices Notified Bodies (Team-NB) says.
The FDA has issued Florida-based test manufacturer Empowered Diagnostics a warning letter for distributing COVID-19 test kits without marketing approval, clearance, or authorization.
The FDA has accepted Harm Reduction Therapeutics’ (HRT) new drug application (NDA) for RiVive, an investigational over-the-counter (OTC) nasal spray containing 3 mg of naloxone, and has granted the drug-device combination a priority review.
Advanced Bionics has agreed to pay more than $12 million to resolve allegations that it made false claims in premarket approval applications (PMAs) for some of its cochlear implant processors, the Department of Justice said.
The De Novo pathway is an option for applicants with novel medical devices which are considered reasonably safe and effective under certain controls, but have no legally marketed predicate device.