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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.
Philips is temporarily pausing reworking its recalled Respironics Trilogy 100 and Trilogy 200 ventilators after two new issues have been found with breakdown in the devices’ sound abatement foam.
BioTelemetry and its subsidiary CardioNet — both owned by Philips — have reached a $44.8 million agreement with the Department of Justice (DOJ) to resolve False Claims Act allegations that the companies billed the federal government for test analysis performed outside the U.S.
The U.S. International Trade Commission (ITC) has affirmed its June initial decision and has once again sided with AliveCor that Apple infringed on AliveCor’s wearable electrocardiogram (ECG) device patents, potentially halting importation of certain Apple watches.