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Back by Popular Demand – Wearable Medical Devices – FDA’s Current Thinking






As this presentation was so well attended in July FX Conferences has decided to rerun this presentation twice in August so those that missed it can obtain this critical information for the Wearable Medical Device industry.  Leo Eisner will be speaking on Medical Device Wearables & FDA’s Current Thinking with respect to a slew of [...]

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Presentation on Wearable Medical Devices – Current Thinking from FDA






Leo Eisner will be speaking on Medical Device Wearables and the Current Thinking from FDA with respect to myriad of new guidance documents that may apply to your devices.  This presentation is being offered 2 times in July (Tuesday July 21, 10:00AM Eastern and Thursday July 23, 1:00PM Eastern).  The best thing is you don’t [...]

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Part 2 – Wearables the rage but are they medical devices?






Part 2 of series Posts – “General Wellness” & “Medical Device Accessories” FDA Guidances in regard to Wearables. Join us @ 10X conference & learn more From the previous “Wearables the rage but are they medical devices?” blog post I indicated that to determine if Wearables are medical devices you must a) review the definition of [...]

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510(k) Workshop at 10X Conference






On May 4, 2015 in San Diego, I, Leo Eisner, am presenting along with 2 other experts in the field on the 510(k) process. The 10X Conference is from May 4 – 6, 2015 at the Hilton San Diego Mission Valley.  It would be great to meet you at this workshop or the entire conference [...]

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Wearables the rage but are they medical devices?






Guidance documents to help you determine if your Wearable device is a medical device that needs FDA approval or not for US submissions. Wearables may be the rage but what does your company need to do for an FDA medical device submission in the US (or do you even need one from the FDA?) with [...]