News

Grit Daily1h
Mexico’s AI Revolution: Turning Smartphones Into Medical Devices to Combat a Health Crisis
A Mexico City startup has achieved the Western Hemisphere's first SaMD regulatory approval for its proprietary AI-powered ...
ConsumerAffairs4h
Moderna wins FDA approval for its new COVID-19 vaccine
FDA approves Moderna’s mNEXSPIKE COVID-19 vaccine for high-risk groups Phase 3 trial shows mNEXSPIKE outperforms original ...
The Manila Times5h
FDA expands XENOVIEW® indication to include children from six years of age
XENOVIEW™, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and ...
STAT6h
FDA plans to begin rolling out AI tool agency-wide on Tuesday
The FDA plans to roll out its agency-wide AI tool weeks ahead of schedule, per a press release that provides the most ...
Modern Healthcare7h
The race is on for brain-implantable devices
Brain-computer interface technology shows promise in helping motor-impaired patients, like those with Lou Gehrig's disease, ...
Medical Device Network on MSN9h
FDA grants breakthrough device status to BiVACOR’s artificial heart
The US Food and Drug Administration (FDA) has granted breakthrough device designation to BiVACOR’s titanium Total Artificial ...
New device helping stroke survivors in Connecticut. Now UConn is trying to expand the program
A breakthrough nerve therapy is improving stroke survivors' mobility and quality of life. A UConn doctor is asking the state ...
FDA grants limited approval to new Covid vaccine from Moderna
Moderna announced this weekend that the Food and Drug Administration approved its lower-dose Covid-19 vaccine for adults 65 ...
STAT22h
FDA commissioner evades questions on Covid shot, calls CDC panel a ‘kangaroo court’
In a new interview, the FDA commissioner had few answers on how Americans should think about Covid vaccines. Instead, he ...