What you need to know about the forces reshaping our industry.


July 19, 2019

Is your patient's medical device under recall? This app will let them know.

Daily Briefing

    A tech company on Monday launched a smartphone app that immediately alerts patients, providers, and caregivers when FDA recalls a medical device.

    SoomSafety app alerts providers, patients of FDA recalls

    Boston-based tech company Soom launched its mobile app SoomSafety on July 15 to close the information gap between medical device users and FDA in the case of a device recall.

    Users can store their medical device on the app either by scanning the barcode on the device, such as an insulin pump or nebulizer, or by scanning their medical device identification card for implanted medical devices, such as artificial joints or pacemakers.

    Once the device is stored, the app uses information from open FDA, a database that grants developers access to FDA data, to provide users with instructions on how to use the device as well as safety information.

    The app also automatically checks for updated FDA recall information and provides users with next steps in the event of a recall.


    While medical device recalls have a direct impact on patient safety, recall notifications can be difficult to find, according to Charlie Kim, president and CEO of Soom. In 2019, companies issued 26 medical device recalls, affecting about 50 million people with medical devices, but many of these patients were never informed of the recalls due to "incomplete information in the medical device supply chain," he said.

    "I've experienced first-hand what it feels like to wonder if a medical device that your loved one uses—relies on—is safe," he said. "It's a feeling that no patient, parent, or caregiver should have to endure."

    Soom said its mobile app is the first to close the information gap between FDA, medical device manufacturers, and medical device users.

    "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," he said. "We built SoomSafety to help patients and caregivers relying on … medical devices … answer one critical question, 'Is this medical device safe to use?'"(Paavola, Becker's Hospital Review, 7/17; Landi, FierceHealthcare, 7/15; Benyon, Oncology Nursing News, 7/17; Lovett, MobiHealthNews, 7/16).

    Have a Question?


    Ask our experts a question on any topic in health care by visiting our member portal, AskAdvisory.