Global Device Approvals, Weekly Snapshot: June 18-24, 2018

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.

Approved

Fourteen novel device or indication approvals were added to Medtech Insight's Approvals Tracker last week. Diabetes devices got the most attention, along with hemodialysis and a range of other clinical specialties.

The diabetes focus aligned with the American Diabetes Association annual meeting (June 22-26 in Orlando, Fla.). Tandem Diabetes Care Inc. entered the predictive automated insulin delivery space with US...

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EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
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Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.