Posts Tagged ‘Regulatory Affairs’

Approval of “Living Drug” to Treat Cancer

Posted on: September 1st, 2017 by admin 4 Comments

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

Posted on: August 4th, 2017 by admin 4 Comments

The International Electrotechnical Commission (IEC) has published standard IEC 60601-1 for medical electrical equipment that mandates general requirements for basic safety and […]

South Africa’s New Regulations

Posted on: August 26th, 2016 by admin 2 Comments

For the past two days the South African Medical Device Industry Association (SAMED) has been holding its annual conference in […]

The Best-Laid Schemes

Posted on: April 15th, 2016 by admin 3 Comments

In 1785 the Scottish bard Robert Burns wrote his iconic poem “To a Mouse”, which begins with the immortal words: Wee, sleekit, […]

Reducing Hair Loss During Chemotherapy

Posted on: December 11th, 2015 by admin

A distressing side effect for women undergoing chemotherapy to treat breast cancer is alopecia – hair loss in which the […]

Is the FDA Too Slow?

Posted on: August 21st, 2015 by admin

Any company that hopes to crack the United States medical device market, currently worth more than $100 billion per annum, […]

Regulation of Medical Devices in South Africa

Posted on: August 14th, 2015 by admin

A month ago today on 14 July 2015, the Government Gazette of the Republic of South Africa published an important document entitled […]

Gene Testing Called into Question

Posted on: May 29th, 2015 by admin

Recent advances in gene sequencing technology have led to multi-gene testing – also known as “panel testing” – as a […]

True 3D X-ray Breast Images

Posted on: February 13th, 2015 by admin 1 Comment

As we have highlighted in the past few years, an imaging technology that has created a real buzz is digital breast tomosynthesis (DBT). Although […]

FDA Takes 3D Diagnosis Seriously

Posted on: October 3rd, 2014 by admin 2 Comments

The Food and Drug Administration (FDA) has just published a report entitled “3D techniques poised to change how doctors diagnose cancers.” The FDA’s […]