FDA issues new medical and mobile device draft guidance

The FDA hopes to encourage innovation and interoperability by lowering the regulatory burden on medical device data systems in a new draft guidance published June 20.

The document also proposes edits to the mobile medical applications guidance.

Around the web

The nuclear imaging isotope shortage of molybdenum-99 may be over now that the sidelined reactor is restarting. ASNC's president says PET and new SPECT technologies helped cardiac imaging labs better weather the storm.

CMS has more than doubled the CCTA payment rate from $175 to $357.13. The move, expected to have a significant impact on the utilization of cardiac CT, received immediate praise from imaging specialists.

The all-in-one Omni Legend PET/CT scanner is now being manufactured in a new production facility in Waukesha, Wisconsin.

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