According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...

The US Food and Drug Administration (FDA) has authorised the first at-home PCR STI test for chlamydia, gonorrhoea, and ...

SonoMotion has received the US Food and Drug Administration (FDA) de novo clearance for its Stone ... was originally created and published by Medical Device Network, a GlobalData owned brand.

The FDA has cleared its first completely at-home sexual health test for women, available over-the-counter to screen for ...

The device is now on track for its first FDA approval under the de novo pathway ... access care,” said Paul Gianneschi of ...

March 28, 2025 /PRNewswire/ -- Today, Visby Medical™, a leading innovator in medical diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for ...

CTSO READ THE FULL CTSO RESEARCH REPORT Update on the DrugSorb-ATR Regulatory Process Management reiterated that their De Novo DrugSorb-ATR submission continued to be in interactive review with FDA, ...

After 12 years of development, our device delivers rapid ... The granting of this De Novo marketing authorization positions Visby Medical for significant expansion into the at-home diagnostics ...

March 28, 2025 /PRNewswire/ -- Today, Visby Medical™, a leading innovator in medical diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization ...