The U.S. Food and Drug Administration (FDA) announced it is building the foundations of a national evaluation system to generate better evidence more efficiently for medical device evaluation and regulatory decision-making. The agency said a national evaluation system would generate evidence across the total product lifecycle of medical devices by strategically and systematically leveraging real-world evidence, and applying advanced analytics to data tailored to the unique data needs and innovation cycles of medical devices.

In 2016, the America Cancer Society expected 1,685,210 new cancer diagnoses in the United States alone. And according to the National Cancer Institute, approximately half of all patients diagnosed with cancer will undergo radiation therapy as part of their treatment plan. Given the large number of patients turning to radiation oncology, it is no wonder there is an immense focus on continually advancing this treatment technique. Millions of lives depend upon it.

The world of X-ray takes a big step into the future this year with scheduled Medicare reimbursement cuts under the Consolidated Appropriations Act (CAA) of 2016. Hospitals and clinics still using analog (film) X-ray machines now face a 20 percent reduction for exams conducted on these systems.

Organizations across the country — even globally — are taking a hard look at their imaging ecosystems and determining it is time for change. Most technology and clinical leaders have read, listened to and observed the imaging vendor narrative over the past few years while they focused primarily on deploying the electronic health records (HER). Now most feel comfortable enough — either internally or with the help of consultants — to tackle this next huge patient record initiative. Vendor neutral archives (VNA), viewers, workflow, analytics, integration and exchange are all under review as components of the enterprise imaging effort. The good news for those in this phase of discovery and analysis is that the pioneers are far enough down the path to prove that an enterprise approach can be incredibly successful and that there are organizational, clinical, technical and even financial benefits to adopting this model.