Your Sub-Licensed GE Software Options on your Diagnostic Imaging Equipment May NOT be Transferable? Find out what this could mean for you here.
The FDA announced it does not intend to enforce the requirement to use its unique device identifier system for labels on medical devices manufactured and labeled before Sept. 24, 2021. In final guidance issued Aug. 30, the agency said stakeholders had expressed concern that pharmacies and other entities in the supply chain were not prepared [...]
On July 13, 2016, GE Healthcare sent a letter to IAMERS, which we understand was also sent to others who are brokers and resellers of GE Healthcare Medical Imaging Devices. This letter details GE Healthcare's policy on the Terms of Software Non-Resale. Click here to read the letter.
Why is this happening now? According to the docket itself, the FDA’s renewed interest in refurbishment came as a response to safety concerns brought to its attention. It’s also a chance to address ambiguities in the way certain terms associated with refurbishment and third-party service are defined. “We hope that this current effort provides additional [...]
GE Healthcare wants brokers and re-sellers of its medical equipment to be aware that not all the software on its CT or MR systems can necessarily be bundled into the sale of the equipment itself. Read more here.
Now that the commenting period has ended, the FDA plans to host a two-day public workshop for stakeholders to discuss the questions raised in its third-party service and refurbished medical device docket. Read more here.
The 12th Annual European Meeting is coming up soon on 14–16 September in Lisbon, PT. The meeting will begin on Wednesday night (14 September) with a reception and dinner. Business sessions will be held on Thursday and a partial day Friday. There will be a reception and dinner in a local restaurant on Thursday night. BUSINESS SESSIONS Keynote [...]
Apple is hiring a lawyer who specializes in medical privacy, hinting at bigger health tech ambitions
Apple wants to hire a high-level lawyer who specializes in health privacy regulations, the latest sign of the iPhone maker's growing ambitions in the healthcare market. Read more here.
Health care is unique in its economics, but regardless of how it’s defined, an emerging market is clear: consumerism and information seeking, Saurabh Jha, MBBS, assistant professor of radiology at the Hospital of the University of Pennsylvania, said at ACR 2016. Read more here.
For more than 20 years, I have been attending the IAMERS Annual Meeting. I am always glad that I attend; I always walk away a little bit smarter and it gives me the chance to see a lot of different people. This year was no exception. Read more here.