Read more here. “Nowhere in the white paper does MITA provide support for its claim of an increased "risk to the public health." As MITA once acknowledged in its previous submission to the FDA it is impossible to provide a statistically valid analysis of the extent of problems.”
While current FDA standards regulate the remanufacturing of medical devices, regulation of servicing is not a requirement. In addition, few safeguards exist to prevent the crossover of servicing activity with that of remanufacturing, creating increased risks to public health, the safety of patients and providers who use the technology. These risks are elaborated on in [...]
“Despite organizations’ large investments in security, email fraud continues to rise,” the report authors wrote. “Cybercriminals are growing more advanced. And attacks are evading traditional security tools, leaving people as the last line of defense.” Read more here.
Medical imaging technologies and machine learning will support a new generation of tools that can personalize treatments and improve outcomes for patients. Read more here.
CEO Larry Culp acknowledged as much in a post-earnings conference call, stating, “We expect to monetize just up to under 50 percent of our health-care business,” adding that the unit “continues to prepare for public company separation, and that is progressing very well," Read more here.
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.
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 [...]
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 [...]
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 [...]