FDA inspectors found Cue made unauthorized changes to its COVID-19 kits that “reduced the reliability of the tests.” ...

For medical products, the tariff increases focus on syringes, face masks and gloves — areas where the U.S. has sought to ramp up domestic production after the start of the pandemic. The U.S. imported ...

Megadyne discontinued the product globally after receiving four reports of patients being burned in procedures where the electrode pads were used.

Michelle Tarver, an FDA official, said a new program is meant to advance health equity by considering people’s living conditions as part of medical device design.

The affected devices were manufactured by an outside supplier, not Route 92, and suffered product quality problems.

Lindsey’s onboarding supports NextBeam’s growing momentum. In 2023, NextBeam achieved remarkable milestones, including the ...

In addition to the partnership announcements, Dr Sharp also celebrated the one year anniversary of the launch of the Galvan+ ...

Nearly three years after publishing draft guidance, the FDA has changed the title and added a section on the regulatory requirements for remanufacturers in the final version of the text.

No one solution can match the scope and scale of ethylene oxide, but a “multi-pronged approach” can help reduce emissions, an FDA official said.

After months of safety concerns, the FDA said Getinge has yet to “sufficiently” address the problems and risks.

Activist investor Politan immediately snubbed Masimo’s offer to accept one nominee to its board, insisting two new directors are needed to resolve governance issues at the pulse oximetry specialist.

Officials will accept atrial fibrillation data collected by the wearable as a secondary endpoint in studies of cardiac ablation devices.