Earlier this week in the United States, the Food and Drug Administration (FDA) published an action plan for the use of artificial […]
Posts Tagged ‘Regulatory Affairs’
Vaccines for Breast Cancer
For the past few weeks, there has been understandable excitement that vaccines to inoculate people against the Covid-19 virus have […]
And the Winner is …
James Dyson is the inventor of the bagless vacuum cleaner and other consumer products, including the Airblade hand dryer, an ultrasonic humidifier […]
Does 3D Mammography Save More Lives?
A week ago, USA Today published an article written by Liz Szabo (seen right) with the provocative headline, “Massive marketing muscle pushes […]
Language of Breast Density
Over the years, we have written multiple articles about breast density, including its reduction, legislation, diagnostic challenges and workflow optimization. One may reasonably ask: Why this […]
FDA Hit by Government Shutdown
Just north of downtown Washington, DC, in suburban Maryland, lies the sprawling campus of the Food and Drug Administration (FDA), […]
Don’t Lose the 3
Six years ago, the CEO of French manufacturer Poly Implant Prosthese, Jean-Claude Mas, was convicted and sent to jail for using non-medical […]
Hanging Out on Hanging Rock
CapeRay currently holds the ISO 13485:2012 certificate, an international quality assurance standard that enables the “design, development, manufacture, installation, distribution and servicing […]
Approval of “Living Drug” to Treat Cancer
In 2012 six-year-old Emily Whitehead was diagnosed with acute lymphoblastic leukaemia and, since she did not respond to standard treatment, was near […]
Of Testing and Cartoonists
The International Electrotechnical Commission (IEC) has published standard IEC 60601-1 for medical electrical equipment that mandates general requirements for basic safety and […]