Varian Medical Systems to acquire PerkinElmer’s medical imaging business for $276 million

Varian Medical Systems’ imaging components business announced an agreement to acquire PerkinElmer’s medical imaging business for $276 million. In addition, the components business will become an independent public company called Varex Imaging Corporation in January 2017. PerkinElmer’s medical imaging business is a supplier of digital flat-panel X-ray detectors that can be used for industrial, medical, dental and veterinary X-ray systems.

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Varian Medical Systems Spin-Off: What To Do?

Varian Medical Systems (NYSE:VAR) spin-off is getting closer to completion. The company has filed its separation and distribution agreement which you can find here. The filing still doesn’t give details into exactly what the distribution ratio will look like. The spin-off is planned to be a tax-free distribution. I expect it to be completed in the first quarter of 2017. The new company name will be Varex Imaging.

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Dr. Michael Friebe’s 2016 RSNA Technology Overview

Click here to see what Dr. Michael Friebe’s thought of the 2016 RSNA.

 

ECRI issues its annual list of the top health technology hazards

Every year, ECRI Institute’s Health Device Group issues a list identifying the top ten potential device-related sources of danger in the coming year. Along with the list, accompanying strategies for mitigating the various trouble-areas are also included.

Read more here.

Did You Know?

Your Sub-Licensed GE Software Options on your Diagnostic Imaging Equipment May NOT be Transferable?

Find out what this could mean for you here.

FDA Holds Off on UDI Label Enforcement for Devices Made Before September 2021

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 for the transition. The deadline for labeling most Class I and Class II devices is Sept. 24.

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GE Healthcare Announces Terms of Software Non-Resale

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.

An in-depth look at the FDA’s refurb docket

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 clarity on how these activities are defined, and what are some key considerations on the benefits and risks associated with these activities,” Deborah Kotz, press officer of media affairs and external affairs for the FDA

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GE asks third-parties to stop selling CT and MR with sub-licensed software on them

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.

FDA announces public workshop to discuss third-party refurb docket

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.

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