Here are the top 5 medtech stories of mid-2017

Movement on implementing UDIs

Makers of devices such as manual surgical instruments and mechanical wheelchairs will have two extra years to get these Class I devices submitted to the Global unique device identification database (GUDID), FDA announced in June.

In a letter to industry, FDA announced plans to push label, GUDID submission, and standard date format requirement dates to September 2020. Direct mark requirements will go into effect in September 2022. The agency also said it will release a guidance document regarding its enforcement decision, but wanted to inform industry as early as possible.

Meanwhile, Sens. Chuck Grassley, R-Iowa, and Elizabeth Warren, D-Mass., sent a letter to the Accredited Standards Committee X12 recommending the addition of medical device identifiers to insurance claims forms. The senators urged the X12 committee, which is accepting public comments through the end of the day today, to continue supporting this key policy change. Their letter underscores the bipartisan support for adding device identifiers to claims.

The 10 hottest medtech startups of 2017>>

Theranos whistleblower Tyler Shultz to participate in keynote interview at DeviceTalks Boston At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos. Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston. REGISTER NOW