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New legislation would mandate all ISOs register with FDA

IAMERS Counsel Robert Kerwin to appear on May 2, 2017 before the U.S. House of Representatives Committee on Energy and Commerce on the Legislation. On Tuesday, April 25, 2017, Congressman Ryan Costello (R-PA) and Congressman Scott Peters (D-CA) with the support of the Medical Imaging Technology Alliance, filed H.R. 2118 seeking to require registration of [...]

By |2017-04-28T06:46:04+00:00April 28th, 2017|Government, Legal Advice, Reform, Regulatory|Comments Off on New legislation would mandate all ISOs register with FDA

IAMERS’ BEST Practices Committee To Present On Quality Management Systems At New Orleans Annual Meeting

The Best Practices Committee has issued recommended quality management templates for IAMERS members. The templates pertain to Complaint Management, Traceability, Training and Data Management. The Committee recommends IAMERS members engage in an internal review process to determine how the templates may be best used.  

By |2017-04-13T14:48:30+00:00April 13th, 2017|Uncategorized|Comments Off on IAMERS’ BEST Practices Committee To Present On Quality Management Systems At New Orleans Annual Meeting

License Restrictions in the United States

We have been extensively examining the license restriction situation and have had a discussion on license restrictions with the Federal Trade Commission. We are at this time of the view that those who hold dominant positions in the diagnostic imaging market and seek to enforce license restrictions only when the relationship is not a strategic [...]

By |2017-04-13T14:48:08+00:00April 13th, 2017|Uncategorized|Comments Off on License Restrictions in the United States

License Restrictions in Europe

President Upton and General Counsel Robert Kerwin met with the Head of DG Comp’s Antitrust Pharma and Health Services in Brussels last month  and discussed our view that Directive 2009/24/EC and the 2012 ECJ decision UsedSoft GmbH vs. Oracle made clear in the EC that a first sale exhausted the right to restrict licenses to [...]

By |2017-04-13T14:47:21+00:00April 13th, 2017|Uncategorized|Comments Off on License Restrictions in Europe

Ethics Code Changes

We are circulating proposed changes k for consideration by the membership. Your voice is important to us. Please give us your comments, proposed changes, if any and offer any other changes. This is perhaps the first time in almost 25 years. That we are suggesting proposed changes is in light of the fact (as the [...]

By |2017-04-13T14:42:34+00:00April 13th, 2017|Uncategorized|Comments Off on Ethics Code Changes

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, [...]

By |2016-12-31T16:51:57+00:00December 31st, 2016|Business|Comments Off on Varian Medical Systems to acquire PerkinElmer’s medical imaging business for $276 million

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 [...]

By |2016-12-31T16:50:56+00:00December 31st, 2016|Business|Comments Off on Varian Medical Systems Spin-Off: What To Do?

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.

By |2016-11-15T08:25:43+00:00November 15th, 2016|Business|Comments Off on ECRI issues its annual list of the top health technology hazards
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