Medical Devices

FDA has ordered surgical mesh for transvaginal repair of pelvic organ prolapse (POP) manufacturers Boston Scientific and Coloplast to stop selling and distributing the products, the agency announced Tuesday (April 16).

New findings from duodenoscope sampling studies show the number of high-concern organisms found on reprocessed duodenoscopes is nearly 2.5% more than what FDA originally reported back in 2018, the agency’s device center director announced Friday (April 12).

The new chairman of the Advanced Medical Technology Association’s (AdvaMed’s) board of directors, Kevin Lobo, says the most pressing issue facing the industry is the Affordable Care Act’s 2.3 percent excise tax on medical devices, the latest moratorium on which ends next year.

In a white paper released Tuesday (April 2), FDA details an oversight process that outgoing agency commissioner Scott Gottlieb said could allow artificial intelligence-based medical devices to iterate autonomously while still letting FDA provide a reasonable assurance of safety and effectiveness.

FDA is proposing to amend its regulatory framework for mammograms and mammography facilities, which would include for the first time a federal requirement that breast density information be included in communications to patients and health care providers, the agency announced Wednesday (March 27).

Durable medical equipment lobbyists took their fight against adding ventilators to the competitive bidding program to the White House Domestic Policy Council after vowing to pressure the administration and Congress to change the policy.

FDA is launching a broad effort to revisit implantable device regulation in light of a growing body of data that shows material in some devices could harm certain patients, according to outgoing agency chief Scott Gottlieb and device center head Jeff Shuren.

Several medical device industry lawyers say FDA guidance that outlines how companies can seek feedback on actions they propose to correct problems found during inspections puts industry in a quandary.

As speculation of who could be confirmed to permanently replace FDA Commissioner Scott Gottlieb circulates among the media and stakeholders, consumer advocates say they would prefer someone who has fewer ties to industry while one industry consultant hopes the next commissioner will be an outsider who has familiarity with data and technology yet can still work within the guardrails of FDA.