The medical device tax went into effect in 2013, but its impact was felt even earlier, as device companies prepared for the 2.3% excise tax via widespread layoffs. And although the tax was put on hold for two years as of December 2015, the damage had already been done. According to recent numbers from the U.S. Department of Commerce, between 2012 and 2015, the U.S. medtech industry lost 28,834 jobs—a 7.2% decrease. The majority of job losses were seen in 2014, with the industry losing about 27,000 positions in the industry.
The UK MHRA has published “Software and Artificial Intelligence as a Medical Device.” The guidance document assembles previous guidances and regulatory requirements for SaMD and AIaMD devices seeking commercialization in the UK market.
“Addressing unmet needs across pediatric populations is critical to advancing children’s health, and we are delighted to once again work with pioneering companies that seek to bridge this care gap."
More and more, the quality of real-world evidence (RWE)—gathered from remote patient monitoring data, product and disease registry data, and patient feedback—determines whether a medical device is approved and, in some instances, for how long. Yet some medical device manufacturers…
The MDDT program was developed in collaboration with the National Institutes of Health’s (NIH’s) National Institute of Drug Abuse (NIDA), National Institute of Dental Craniofacial Research (NIDCR) and National Cancer Institute (NCI) as a way for the FDA to qualify…
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