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UDIs

Here are the top 5 medtech stories of mid-2017

June 23, 2017 By Heather Thompson

The middle of 2017 is shaping up to be a continued whirlwind of activity for medtech. FDA is getting used to its new leadership but is facing a continued lack of clarity on user fees and UDIs. Industry is seeing a deeper consolidation in medical supplies, exemplified in Cardinal Health’s purchase of patient recovery supplies from […]

Filed Under: Business/Financial News, Diabetes, Digital Health, Food & Drug Administration (FDA), Mergers & Acquisitions, Regulatory/Compliance Tagged With: Apple, Apple Watch, BD, becton dickinson, C.R. Bard, Cardinal Health, Dexcom, FDA, Medtronic, spectrumplastics, UDIs, Unique Device Identifier (UDI)

FDA extends UDI compliance date for low risk devices

June 5, 2017 By Heather Thompson

Labelers of class I and unclassified devices recently got a reprieve when FDA announced an extension of the compliance date for unique device identification (UDI). Makers of devices such as manual surgical instruments and mechanical wheelchairs will have 2 extra years to get these devices submitted to the Global unique device identification database (GUDID), FDA announced last […]

Filed Under: Food & Drug Administration (FDA), Health Information Technology, News Well, Regulatory/Compliance Tagged With: FDA, UDIs, Unique Device Identifier (UDI)

Why adding device identifiers to insurance claims protects patients

May 22, 2017 By Heather Thompson

The pushback to adopting unique device identifier into claims forms is that the added steps will be burdensome for hospitals. But documenting device identifiers in claims forms is actually “feasible” and “straightforward,” and requires only modest effort, according to a new whitepaper from Boston’s Brigham and Women’s Hospital. Of particular concern was that the device claims […]

Filed Under: Blog Tagged With: Brigham and Women's Hospital, health insurance, MedTech, UDIs, X12 advisory committee

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