Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
3. Medtronic details humanitarian sales to Syria, Cuba, Sudan
The U.S. Securities & Exchange Commission closed its review of Medtronic’s sales to strife-torn Syria and Sudan and to Cuba, which the medical device company said are made on a humanitarian basis and amount to a small fraction of its total business.
The SEC asked Medtronic in January to explain its business contacts in the 3 nations, which are flagged as state sponsors of terrorism and are subject to U.S. economic sanctions and assets controls. Read more
2. Diabetes: FDA releases DexCom warning letter
The FDA’s release of a warning letter sent Dexcom Inc. this month reveals that the glucose monitoring company failed to report at least 4 incidents of low blood sugar requiring medical attention and at least 1 instance in which the device shocked a patient.
Dexcom disclosed the March 14 warning letter earlier this week, saying only that the letter flagged “deficiencies in filing medical device reports (MDRs) involving the company’s continuous glucose monitoring system.” Read more
1. Medtech gears up for Medtronic’s RDN trial results
MASSDEVICE ON CALL — The medical device world will be watching intently this weekend as Medtronic releases data for the 1st time from a failed clinical trial of its Symplicity renal denervation device.
Medtronic is slated to present its initial findings from the Symplicity HTN-3 study tomorrow at the American College of Cardiology’s annual meeting in Washington. Read more
