FDA Commissioner Califf Hasn’t Heard from Trump Yet

By MedTech Intelligence Staff

Rumors emerge that Robert Califf, M.D. may leave the agency.

Medical Innovation in an
Age of Overregulation

By Jacob Andra, U.S. Translation Company

Do regulators have a disincentive to approve medical devices?

FDA Confirms Cybersecurity Vulnerabilities with Certain
St. Jude Medical ICDs

By MedTech Intelligence Staff

If exploited, unauthorized access to these devices could have dangerous consequences.

Is the United States really Tilting Toward Asia?

By Ames Gross, Pacific Bridge Medical

The country can’t ignore the fact that Asia is the future of medtech growth.

Featured Quote

Rapid diagnosis and aggressive clinical intervention is critical for patients to survive sepsis, and even short delays in sepsis identification and administration of treatment can negatively impact patient outcomes and increase mortality.

— David Ludvigson, Nanomix

Devine Guidance

Who's on First?

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

An adequate structure must be in place to support a QMS.

Theranos Gets Rid of
41% of Staff

By MedTech Intelligence Staff

The company is eliminating 155 positions.

Trump’s Impact, Pricing,
R&D Funding and Cybersecurity Among Top Trends of New Year

By MedTech Intelligence Staff

It’s too early to tell how the new administration will affect the device industry, but user fees, the ACA and the FDA regulatory process are top of mind.