Mainz Biomed seeks FDA breakthrough device status for colorectal cancer test
Mainz Biomed has submitted an application to the US Food and Drug Administration (FDA) seeking breakthrough device designation for its…
Mainz Biomed has submitted an application to the US Food and Drug Administration (FDA) seeking breakthrough device designation for its…
India-based clinical-stage medical diagnostics company RNT Health Insights has received breakthrough device designation (BDD) from the US Food and Drug…
Ambu has obtained 510(k) regulatory clearance from the US Food and Drug Administration (FDA) for its new-generation duodenoscopy solution, the…
Implantica has started the premarket approval process with the US Food and Drug Administration (FDA) for its gastroesophageal reflux disease…
Fujifilm Healthcare Americas has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new AI-based endoscopic…
The NHS in the UK has reported that an innovative capsule sponge test could effectively diagnose Barrett's oesophagus, a precursor…
The US Food and Drug Administration (FDA) has granted 510(k) clearance to EndoSound’s Vision system, an endoscopic ultrasound device. Endoscopic…
US-based clinical-stage company GIE Medical in the US has enrolled the first patient in the trial of a drug-coated balloon…
Biora Therapeutics has submitted an updated investigational new drug (IND) application with the US Food and Drug Administration (FDA) for…
Microba Life Sciences has signed a distribution agreement with Sonic Healthcare through its wholly-owned subsidiary Douglass Hanly Moir Pathology, for…