The US Food and Drug Administration (FDA) has granted Alleviant Medical an investigational device exemption (IDE), enabling the company to begin a pivotal trial evaluating its atrial shunt ...

Sooma Oy secured U.S. FDA investigational device exemption approval to initiate a pivotal study of its transcranial direct ...

Sooma announced that it received FDA investigational device exemption (IDE) for its transcranial direct current stimulation ...

Lungpacer Medical announced that it received FDA investigational device exemption (IDE) approval to begin a trial for its ...

Lungpacer Medical, a leading neurostimulation company committed to advancing therapies that assist patients in overcoming the negative effects of mechanical ventilation (MV), is excited to announce ...

Interim data on Spineart’s Baguera-C cervical disc shows the device meets the threshold for a non-inferiority claim compared to a study control, the medtech company said March 11. Spineart plans to ...

today announced a corporate restructuring and realignment of resources to prioritize its FULCRUM-VT US pivotal investigational device exemption (“Pivotal IDE”) clinical trial activities and its new ...

EXTON, Pa., March 10, 2025 (GLOBE NEWSWIRE) -- Lungpacer Medical, a leading neurostimulation company committed to advancing therapies that assist patients in overcoming the negative effects of ...

The AeroNova System is a novel, minimally invasive medical device designed to deliver continuous diaphragm neurostimulation in tandem with mechanical ventilation. The investigational device aims ...