GE to spin off healthcare unit in latest restructuring

Moody's and investors applauded the move, which comes amid a reboot of the health division.

By Meg Bryant • June 27, 2018

FDA unveils software Pre-Cert update

The agency hopes to finalize the working model by the end of the year and launch a large-scale pilot program in 2019.

By Meg Bryant • June 21, 2018

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

UPS seeks to disrupt implantable medical device supply chain

But without device manufacturer buy-in, uptake of the effort appears to be slow.

By David Lim • June 5, 2018

FDA to launch medical device 'innovation challenge' to combat opioid crisis

The agency is dangling its Breakthrough Device designation to spur products, including diagnostics to identify those at high risk of addiction and pain.

By David Lim • May 31, 2018

FDA lays out next steps for Pre Cert pilot

Nine companies are taking part, including Apple, Fitbit and Johnson & Johnson. The program aims to reduce certification checkpoints for software companies for low-risk software-based medical devices.

By David Lim • April 27, 2018

Hospitals must improve medication adherence system use to protect patients, report says

Many hospitals are struggling to properly use technology designed to prevent bedside medication errors.

By David Lim • April 13, 2018

Industry blasts FDA Clinical Decision Software draft

A group that includes software providers, medical device makers and drugmakers says that if implemented, the draft guide would "force many sellers of existing CDS software to remove their products from the market."

By David Lim • Feb. 7, 2018

4 out of 5 US physicians have experienced a cybersecurity attack

AMA President David Barbe says the government, technology and medical sectors need to take a more active roll to stop future cyberattacks to ensure the confidentially of healthcare data. 

By David Lim • Dec. 12, 2017

Hospitals facing IV solution shortages after Hurricane Maria

The FDA has granted one of the largest manufacturers of IV solutions permission to import IV bags from its facilities in other countries.

By David Lim • Nov. 16, 2017

FDA unveils digital health pilot program to speed up certification process

The agency also published its Digital Health Innovation Action Plan, which provides detail and timelines related to digital health and the 21st Century Cures Act.

By Jeff Byers • July 27, 2017