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ENDRA Life Sciences TAEUS De Novo Submission Advances to Next Stage of Review with FDA

ENDRA Life Sciences Inc. , a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound , announces that the Company s De Novo request for the TAEUS liver system has advanced to.

Francois michelonEndra life sciences incDrug administrationLife sciencesSecurities exchangeExchange commissionCompany de novoLife sciences incSciences incThermo acoustic enhanced ultrasoundNon alcoholic fatty liver diseaseChief executive officer francoisSubmission template and resourceSteatotic liver diseaseSecurities actSecurities exchange act

FDA Issues Guidances for Medical Device Transition Plans

The agency has issued the documents to assist with transition plans for COVID-19-related medical devices.

Clinical laboratory improvement amendmentsRadiological healthPublic health emergencyCoronavirus diseaseFederal foodCosmetic actMedical devices issuedSubmission template and resource

FDA Roundup: October 4, 2022

FDA Roundup: October 4, 2022
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Jeff shurenRadiological healthDrug administrationOffice of media affairsConstituent updateSafety alertSubmission template and resourceCollaboration portalElectronic submission templateMedical deviceFact sheetMulti attribute methodTherapeutic proteinsMedia affairs

FDA Roundup: October 4, 2022

/PRNewswire/ Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA posted a.

Jeff shurenRadiological healthDrug administrationOffice of media affairsConstituent updateSafety alertSubmission template and resourceCollaboration portalElectronic submission templateMedical deviceFact sheetMulti attribute methodTherapeutic proteinsMedia affairs

FDA Roundup: October 4, 2022

/PRNewswire/ Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA posted a.

Jeff shurenRadiological healthDrug administrationOffice of media affairsConstituent updateSafety alertSubmission template and resourceCollaboration portalElectronic submission templateMedical deviceFact sheetMulti attribute methodTherapeutic proteinsMedia affairs

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