FDA’s Strategic Policy Roadmap for 2018

For Kapstone Medical

FDA Commissioner aims to streamline review and beef up technical support

FDA Commissioner Scott Gottlieb, MD laid out an 18-page "roadmap" for achieving the FDA’s 2018 goals and objectives. The broad sweep of initiatives addresses four main objectives: reducing opiod and other addictions, leveraging innovation and competition, empowering consumers and strengthening FDA’s scientific workforce.

New Hope for Migraine Sufferers

For Healthcare Associates of Texas

Anyone who suffers from migraines knows they aren’t just bad headaches. Migraines can have symptoms that include severe throbbing pain on one side of the head, flashes of light, blind spots and even tingling on one side of the face. These symptoms can last for hours, and they’re the results of a little-understood neurological disease. (published site)

Fast 3D Printing of Living Cells While Maintaining Viability

POSTED FOR KAPSTONE MEDICAL

A major challenge to 3D printing living tissues is that many 3D printing techniques are based on using heat or ultraviolet light, which can damage or kill living cells.

To address this challenge, researchers at the University of Twente (UT) in Enschede, Netherlands are taking a page from biochip technology that adapted microfluidics for a variety of biocompatible applications.

Is mpMRI the Key to Making Smarter Use of Ablative Technologies?

For Sonacare Medical on Apr 3, 2018 

Focal therapies for cancer have been around for more than two decades and have been accepted treatment options for breast and renal cancers. Gaining acceptance for prostate cancer, however, has been a long-winding road. (published site)

FDA Announces Updates to “Refuse to Accept Policy”

For Kapstone Medical

7 questions to ask before submitting 501(k)

The FDA recently issued updates to its guidance for its “Refuse to Accept Policy for 510(k)s” for Center for Biologics Evaluation and Research-regulated (CBER) devices and for “Acceptance and Filing Reviews for Premarket Approval Applications (PMAs).” (published site)

Making Efficient Use of mpMRI Data

With the growing acceptance of the value of multi-parametric MRI (mpMRI) the detection, diagnosis and treatment of prostate cancer is undergoing a paradigm shift away from biomarkers and standard 12-core biopsies to imaging-based strategies with targeted biopsies.

In a 2015 Korean Journal of Urology review of mpMRI, the authors concluded that, “mpMRI, which is composed of T2WI and several functional sequences, is regarded as the single most accurate imaging modality for characterizing prostate cancer.” (published site)

Healthcare cybersecurity gains, but room for improvement remains

For Hexagon Technology

Efforts to cut cybersecurity breaches appear to be working as healthcare organizations reported 4.5 million healthcare records compromised in 270 breaches in 2017, according to the Office of Civil Rights. (published site)