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FDA grants 510(k) clearance for Visby’s respiratory infections detection test
The US Food and Drug Administration (FDA) has granted 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for Visby Medical’s polymerase chain reaction (PCR ...
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Dexcom nets FDA clearance for 15-day CGM
Dexcom received Food and Drug Administration clearance for a 15-day version of its G7 glucose sensor, the company announced Thursday. Dexcom claims its continuous glucose monitor is the most ...
JD Supra11d
AI Health Law & Policy: Complying with FDA GMP rules for AI-enabled diagnostic devices
The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a ...
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Delcath Systems Announces FDA Clearance of IND Application for Phase 2 Clinical Trial of HEPZATO™ in Liver-Dominant Metastatic Breast Cancer
With the FDA's review complete ... metastatic breast cancer with liver metastases and are candidates for third line treatment. This population includes patients with a significant burden of ...
Morningstar1mon
Agitated Solutions Receives IND Clearance from FDA to Initiate Phase 3 Clinical Trial of a Novel Contrast Agent
Currently, there is no FDA approved right heart contrast agent.” said Morgan Evans, CEO of Agitated Solutions. “This IND clearance is a significant milestone, allowing us to begin our Phase 3 ...