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Primeiro sistema mundial da Leman Micro Devices para monitoramento de saúde clinicamente preciso integrado em smartphone, agora preparado para aprovação da FDA

A Leman Micro Devices (LMD), empresa que desenvolve produtos de cuidados com a saúde apoiada por importantes atores do setor de dispositivos móveis, anunciou que seu sensor e aplicativo de saúde, a única solução integrada ao smartphone que mede a pressão sanguínea e outros sinais vitais com precisão clínica, está sendo preparado para apresentação à FDA e outros reguladores em todo o mundo.

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LMD's Medically Accurate Smartphone Integrated Health Sensor and App (Photo: Business Wire)

LMD's Medically Accurate Smartphone Integrated Health Sensor and App (Photo: Business Wire)

A LMD utiliza a técnica Riva-Rocci, testada e aprovada, para medir a pressão sanguínea. Contudo, em vez de usar uma braçadeira de pressão no braço, o aplicativo de jogo da LMD informa com que força é preciso pressionar o dedo contra o sensor da LMD integrado ao smartphone. Outros recursos oferecem leituras clinicamente precisas sobre a temperatura de seu corpo, assim como a saturação de oxigênio no sangue, frequência cardíaca e taxa de respiração. Todas as cinco medidas são realizadas em qualquer lugar e a qualquer momento em menos de 60 segundos, seguindo instruções simples e sem nenhum acessório extra. Sem necessidade de se despir, sem confusão, sem dor e sem síndrome do jaleco branco. O aplicativo é carregado em fábrica no smartphone e pronto para ser usado de imediato, sem custos para o usuário do smartphone. Não é necessário calibrar durante a vida útil do smartphone.

O Sr. George Alleyne, diretor emérito da Pan American Health Organisation, comenta: “A hipertensão é uma das assassinas mais negligenciadas do mundo, afetando um quarto da população adulta. É facilmente tratada se você souber que sofre da doença. Um dispositivo de medição de pressão arterial simples e confiável, que custa menos de US$ 5, salvaria muitas vidas.

Mark-Eric Jones, CEO da LMD, acrescenta: “O mundo está pronto para smartphones que vêm com um sistema integrado de monitoramento de saúde clinicamente preciso, em vez dos atuais produtos, que não são aprovados e, geralmente, não são precisos. A maioria dos dispositivos vestíveis não medem a saúde, apenas atividades, enquanto outras soluções cobram um preço elevado.Ainda assim, o mercado é enorme - Tim Cook, CEO da Apple, diz que produtos de cuidados com a saúde podem ofuscar o crescimento do mercado de smartphones - e acreditamos que, assim como hoje ninguém compraria um smartphone sem uma câmera de alta qualidade ou sem um GPS, logo os usuários esperarão que funções relacionadas a cuidados precisos com a saúde sejam incluídas no pacote”.

Tim continua: “Nosso produto é testado no laboratório e a FDA já decidiu que é o nosso dispositivo, e não o smartphone propriamente dito, o elemento regulamentado - nesse caso, o smartphone é considerado um "acessório". Esperamos apresentar nosso Health Sensor & App para total aprovação e certificação até o final desse ano.”

Sobre a Leman Micro Devices

Fundada em 2010, a Leman Micro Devices (LMD) tem sede em Lausana, Suíça, no centro do "Health Valley" e perto da Escola Politécnica Federal de Lausana e importantes empresas de sensores de telefone. Fundada pelo Business Angels, capital de risco, e dois outros importantes atores no setor de smartphones, o primeiro produto da empresa certificado pela ISO 13485, é uma combinação exclusiva de sensor e software que mede a pressão sanguínea e outros sinais vitais com precisão clínica, usando um smartphone. O Health Sensor & App, da LMD, deve obter aprovação de órgão regulatório internacional este ano.

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