SCOTTSDALE, AZ, UNITED STATES, June 3, 2025 /EINPresswire.com/ -- Blue Goat Cyber, a leading authority in medical device cybersecurity and FDA compliance strategy, proudly announces its sponsorship of ...

ReShape CEO Paul F. Hickey said that the company achieved MDR and UKCA certification “well in advance” of the Dec. 31, 2027, ...

The Trump Administration has effectively ended the Biden Administration's attempt to regulate lab-developed tests,” TD Cowen ...

On the occasion of World Multiple Sclerosis Day, Ad Scientiam announced that MSCopilot ®, its class IIa Software as a Medical Device (SaMD) dedicated to the monitoring of people living with multiple ...

A Mexico City startup has achieved the Western Hemisphere's first SaMD regulatory approval for its proprietary AI-powered ...

In a new interview, the FDA commissioner had few answers on how Americans should think about Covid vaccines. Instead, he ...

Sleep Better Columbus is now offering FDA-cleared oral appliance therapy for patients diagnosed with mild to moderate ...

The FDA is implementing stricter guidance for the approval of COVID-19 vaccines, according to a paper published in The New England Journal of Medicine.

However, the integration of AI into medical devices raises significant regulatory challenges. Ensuring that these ...

Medical device maker ICU Medical changed the designs of infusion pumps made in Minnesota without properly clearing important regulatory checks after a recent recall, according to a Food and Drug ...

U.S. medical device regulations require manufacturers of most class II and a small number of class I devices to file a 510(k) unless they qualify for an exemption. 510(k) is a premarket technical ...