Irish neurotech company CergenX has received the Breakthrough Device Designation from the US FDA while being accepted into the TAP program.

CergenX announced today that the FDA granted breakthrough device designation for its Wave device for neonatal brain ...

CMS has accepted EBR's WiSE cardiac resynchronisation therapy (CRT) system into the fast-track TCET reimbursement pathway. ..

EBR Systems is girding for US FDA approval of its novel heart lead in April and commercialisation by the end of the year.

The FDA said "an extensive scientific review" found the products were found to pose lower risks of cancer and other serious ...

Transdermal GFR System (TGFR) is a first-in-kind product for point of care assessment of kidney function in patients with normal or impaired ...

With $10 million in new funding, Teal Health co-founder Kara Egan shares how her health care startup intends to reach its first patients.

The FDA is reviewing new vaccines for meningitis and chikungunya and therapies for Parkinson disease and PTSD.

Zyn nicotine pouches loved by young people for their appetite-suppressing effects have officially been approved in the US.

Federal health officials on Thursday backed the public health benefits of nicotine pouches, authorizing Philip Morris ...

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...

FDA alerts and updates on the latest drug and device approvals, recalls, and other regulatory developments in ophthalmology.