In an effort to “close the gap” between the FDA, medical device manufacturers and consumers and/or caregivers, Soom has developed the first app that uses FDA’s open-source database (open FDA) to deliver device instructions for use, safety and recall information right to the user. With the SoomSafety app, users scan the barcode on a medical device, and the app then identifies the device and stores it. Any devices stored in the app are checked for recall information (in addition, when a recall is initiated, the app sends a push notification to the user and informs of next steps). For implantables such as pacemakers or artificial joints, the user scans the barcode on the patient medical device identification card.
“We built SoomSafety to help patients and caregivers relying on implanted medical devices and using medical devices at home answer one critical question, ‘Is this medical device safe to use?'” said Charlie Kim, president and CEO of Soom, in a press release. “Our technology makes it possible to connect previously siloed medical device data, giving patients—and their caregivers—more proactive control over their health and safety.”
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."
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…
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…
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