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 ...

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.

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

The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for NextBioMedical's randomised trial involving its fast-resorbable embolic microsphere, Nexsphere ...

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...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

An FDA optometry roundup discusses changes in drug approvals and devices used by optometric eye care professionals.

Cardiac device innovations made waves in 2024, with regulatory approvals, clinical breakthroughs, and product launches ...

Dr Tsun Sean Law details the ARISE trials and outlines other orthobiologic treatments currently available — but not yet ...