Browsing Tag
FDA clearance
22 posts
4DMedical’s CT:VQ clearance could mark the end of nuclear VQ scans—is the industry ready for software-first lung imaging?
4DMedical’s FDA-cleared CT:VQ may replace nuclear lung scans with software-powered diagnostics. Explore how this breakthrough is reshaping imaging standards.
GE HealthCare launches Vivid Pioneer: Can AI-powered ultrasound redefine cardiovascular imaging?
GE HealthCare launches Vivid Pioneer, its most advanced AI-powered cardiovascular ultrasound system. Explore how it could transform cardiac imaging.
Perimeter Medical Imaging AI (TSXV: PINK) reports 105% revenue growth as pivotal trial data and CMO appointment drive investor focus
Perimeter Medical Imaging AI reports US$506k Q2 revenue, C$3.8m equity raise, and key FDA milestones. Find out what’s next for its AI-driven breast cancer imaging.
Cube Click gains FDA approval for SMILE Dx, unlocking scalable AI revenue in the dental diagnostics sector
Cube Click wins FDA clearance for SMILE Dx, an AI-powered dental diagnostics device poised to transform imaging outcomes and recurring revenue models.
Everest Medicines gains FDA approval for EVM14 cancer vaccine, boosting mRNA oncology pipeline
Everest Medicines secures FDA approval for EVM14, its first internally developed mRNA cancer vaccine, paving the way for global clinical trials.
Game-changing bone marrow kit from SurGenTec gets FDA approval—find out why it’s a big deal
In a significant leap forward for orthopedic and spine technology, SurGenTec, a leading medical device company, has secured…
Akili, Inc. launches EndeavorOTC digital therapeutic for adult ADHD
Akili, Inc. (Nasdaq: AKLI), a leader in digital therapeutics, has announced a significant breakthrough with the U.S. Food…
FDA clears Outset Medical’s TabloCart with prefiltration for enhanced dialysis treatment
Outset Medical, Inc., a leader in innovative medical technology, has announced that the U.S. Food and Drug Administration…
Getinge’s Vasoview Hemopro 3 secures FDA 510(k) clearance: A leap forward in endoscopic vessel harvesting solutions
In a significant development for the medical technology sector, Getinge has announced that the U.S. Food and Drug…
EvoEndo secures AGA investment to scale unsedated transnasal endoscopy technology
Find out how EvoEndo’s unsedated endoscopy platform earned the AGA’s backing—and what it means for the future of GI diagnostics in the U.S.