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베릴리 ‘스마트 워치' 임상평가 자격 "FDA, 승인거절" - 바이오스펙테이터

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베릴리 ‘스마트 워치' 임상평가 자격 "FDA, 승인거절"

입력 2021-06-11 07:15 수정 2021-06-11 08:49

바이오스펙테이터 노신영 기자

이 기사는 '프리미엄 뉴스서비스 BioS+' 기사입니다.
베릴리 웨어러블 기기 ‘스터디 워치’, 파킨슨병 환자의 운동능력 평가를 진행하기에는 부적절

구글의 자회사 베릴리(Verily)가 스마트 워치를 통해 진행할 수 있는 가상 운동능력 평가 프로그램에 대해 미국 식품의약국(FDA)에 임상결과 평가 자격 프로그램(COA Qualification Program) 승인허가서(Letter of Intent)를 제출했으나 결국 거절통보를 받았다.

베릴리는 환자의 실시간 신체건강 정보를 수집할 수 있는 ‘베릴리 스터디 워치(study watch)’를 개발중이다. 스터디 워치는 손목에 차는 멀티센서 기반의 웨어러블 기기로, 비침습적 방법을 통해 지속적으로 심전도(ECG), 심박수, 피부전도도(EDA), 관성운동(inertial movements) 등과 같은 정보를 수집해 해당 정보를 토대로 환자의 건강상태에 대한 모니터링이 가능하다.

신경성 약물개발 임상의 경우, 파킨슨병 평가척도 MDS-UPDRS(Movement Disorders Society Unified Parkinson’s Disease Rating Scale)와 같은 별도의 임상평가척도(clinical rating scale)를 통해 질병의 심각도와 진행정도를 파악하게 된다. 때문에 파킨슨병 평가척도 결과는 파킨슨병에 대한 신약 효능평가 임상에서 1차 종결점으로 지정되는 등 임상 평가지표로 자주 사용된다.

이에 베릴리는 스터디 워치를 통해 성인 파킨슨병 환자를 대상으로 환자의 운동능력 변화를 평가할 수 있는 가상 운동능력 평가 프로그램 ‘Part III Estimator(VME Part III)’를 발표했다. 가상 운동능력 평가 프로그램은 스터디 워치를 통해 수행할 수 있는 총 20분 내외의, 별도의 가이드 없이 환자들이 쉽게 따라할 수 있는 간단한 8가지 운동성 평가(Part III) 테스트로 구성되어 있다....

'프리미엄 뉴스서비스 BioS+'는 독자들에게 가치(value)있는 기사를 제공합니다.
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