Noninvasive Glucose Gets Stuck

Noninvasive Glucose Gets Stuck

James Causey James Causey

James Causey

Medical Device Innovation and Leadership | Team Builder | Maximize Speed to Innovation | Investor Support | Al Mann Award recipient | Inventor (108 issued, 63 published apps)| Litigation (testifying expert)

发布日期: 2024年2月28日
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Noninvasive researchers run aground in the phase in which the technology is to be presented to peers, with one or more convincing experiments that can be repeated and withstand technical challenges.

The De Novo summary for the Dexcom G6, DEN170088, is an excellent outline for noninvasive researchers to model in presenting convincing data if the stated objective is continuous glucose monitoring for people with diabetes. If there is no stated objective or indications for use statement, the effort is research, not R&D.

Questions probing the veracity of a noninvasive adventure may include, "What specific regulation will the product meet?"

Mark Tapsak

Chief Scientific Officer at Glucotrack Inc (Nasdaq: GCTK), CEO of Tapsak Enterprises LLC

1 年

Well said James.

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