The FDA Thursday approved the ARC-EX System designed to restore mobility after spinal cord injury by delivering programmed ...

Flow Medical is developing a thrombolysis catheter that delivers TPA through hollow nitinol tubes to treat pulmonary embolism ...

Devices that are approved through a process that does not require any clinical evidence for FDA authorization should not ...

To address challenges associated with testing novel medical devices for children and perinatal care, the five-year research partnership will involve sharing de-identified clinical data and using ...

This partnership aims to address long-standing challenges in testing novel medical devices for children and for perinatal care. By sharing de-identified clinical data and leveraging advanced ...

These novel medical devices have the potential to significantly improve the diagnosis and care of patients. Those selected for the pilot include medical devices for cancer and chronic respiratory ...

An expert team led by veteran cardiothoracic surgeon Mani Daneshmand, MD, successfully implanted a novel magnetically ... with the device, joined by other leading medical institutions across ...

Amid continued rapid development of novel software products that present new opportunities in the health care space, FDA has yet to grant ...

With approval, the company can begin commercializing the device in the U.S. in 2025.