Integrating Git version control with validation systems automates medical device software traceability, ensuring instant ...

As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to ...

Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices ...

In the waning days of FDA’s fiscal year, the U.S. Food and Drug Administration (FDA) issued the greatly anticipated final guidance “Clinical Decision Support Software,” which aims to clarify the scope ...

A DevOps-based framework integrates automation, continuous integration, and agile methodologies to enhance medical device software development.

The Central Drugs Standard Control Organisation (CDSCO) has issued a draft guidance document on medical device software to bring more clarity on the regulatory aspects of their usage. The document, ...

Researchers from Tokyo Institute of Technology highlight the diverse and emerging nature of SaMD, its growth potential, and transformative impact on healthcare services, in a new study. There has been ...

LEHI, Utah--(BUSINESS WIRE)--Owlet, Inc. (NYSE: OWLT) (the “Company”) announces that the U.S. Food and Drug Administration (“FDA”) has accepted for substantive review the Company’s de novo ...

SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, “Median” or “The Company”), a leading developer of eyonis™, a suite of ...

The FDA recalled 60 medical devices last year, and the running total for this year is 56. The good news is that there’s a startup working to make future totals lower. The startup, named Ketryx, ...