Ameing for Asia

Four Reasons to Source and Manufacture Medical Supplies
in Asia

By Ames Gross, Pacific Bridge Medical

Cost savings and the ability to meet high-volume demands are enticing benefits.

Soapbox

When Health-Related Apps Qualify as Medical Devices
in the European Union

By Emmanuel Garnier
Simmons & Simmons, LLP

According to the Advocate General’s interpretation of the Directive and related soft law (i.e., MEDEV guidelines), software allowing the prescriber to detect contraindications, drug interactions and excessive doses shall qualify as a medical device.

Featured Quote

As the first in the U.S. to provide an FDA-cleared solution to prevent chemotherapy induced hair loss, we’ve seen firsthand the tremendous impact this new technology can have on patient wellbeing.

— William Cronin, Dignitana, Inc.

We Need to Come Together to Learn Complex Surgery

By Mona Orady, M.D., Dignity Health

There is still much to learn about the benefits and potential of robotic surgery.

Following Reported Deaths,
FDA Issues Alert on Intragastric Balloons

By MedTech Intelligence Staff

The agency has alerted healthcare providers of unanticipated deaths related to the systems intended to treat obesity.

Devine Guidance

Is Dr. D Listed on Your Approved Supplier’s List?

By Christopher Devine, Ph.D.,
Devine Guidance International

For all of you CJOs out there, the FDA will never feel a tinge of schadenfreude when writing a boatload of Form 483 observations during an inspection. It is their job to investigate and document compliance issues and concerns.