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Pediatric use of medical devices “requires considerations such as growth and development, anatomical and physiological differences, hormonal influences, and activity level,” the NCC-PDI says.
While the FDA regulates medical devices, it shares oversight of how devices are promoted with the Federal Trade Commission (FTC). This oversight extends to social media, where many companies find avenues for product promotion — and various ways in which advertising can go afoul of the law.
The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) and the Children’s National Hospital are inviting applications from manufacturers with already-cleared devices to use real world evidence (RWE) to gain FDA clearance for pediatric use.
The FDA has granted Class II designations — with general or special controls to assure safety — for several categories of devices submitted to the agency through the De Novo review pathway.
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.
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.
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.