Mela Sciences has filed a citizen petition asking FDA Commissioner Margaret Hamburg to enforce a “binding protocol agreement” and investigate regulators’ conduct as the company struggles to obtain PMA approval for its MelaFind melanoma detection device.
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Flo Health was the first femtech unicorn to be valued at over $1bn. But the company faced 49 investment rejections before reaching that status, Anna Klepchukova, the company’s chief medical officer, told the LSX World Congress Europe. THENA Capital’s Esther Reynal de St Michel Richardot talked through the firm’s gender-smart investment strategy.
Apple and Synchron are teaming up to develop technologies that will one day allow people who can’t use their hands or voice to control iPhones, iPads and other Apple devices by using only their thoughts.
The REFLECT studies showed a 78% reduction in cardiovascular disease-related hospitalization for people living with type 1 diabetes with prior low blood sugar episodes.
