The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...

Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments ...

While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...

The new director of the FDA’s device center contrasted a European rule with the U.S.’s lack of mandatory reporting ...

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...

The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company ...

President Donald Trump has swiftly announced a series of executive orders that could impact the medech industry.

Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in breast tissue.

Amid a deluge of executive actions, the Trump administration has directed federal health agencies to pause external ...

GI Innovation announced on the 20th that it has signed a memorandum of understanding (MOU) with the Chinese bio company ...

A Mokena-based medical supplies executive who sits on the Lakeside Bank board is facing federal fraud charges for allegedly ...