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Bits of information from Marta Gaia Zanchi on the latest in medical innovation and in Medinnovo. Thursday, July 26, 2012. Pre-IDE program revision, one step towards predictability. The US Food and Drug Administration (FDA) has published draft recommendations to revise its voluntary Pre-Investigational Device Exemption (Pre-IDE) program. To include 510(k) premarket notification and Humanitarian Device Exemptions in addition to Investigational Device Exemptions. Posted by Marta G. Zanchi. AAMI / FDA meetin...

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Bits of information from Marta Gaia Zanchi on the latest in medical innovation and in Medinnovo. Thursday, July 26, 2012. Pre-IDE program revision, one step towards predictability. The US Food and Drug Administration (FDA) has published draft recommendations to revise its voluntary Pre-Investigational Device Exemption (Pre-IDE) program. To include 510(k) premarket notification and Humanitarian Device Exemptions in addition to Investigational Device Exemptions. Posted by Marta G. Zanchi. AAMI / FDA meetin...

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medinnovo | medinnovo.blogspot.com Reviews

https://medinnovo.blogspot.com

Bits of information from Marta Gaia Zanchi on the latest in medical innovation and in Medinnovo. Thursday, July 26, 2012. Pre-IDE program revision, one step towards predictability. The US Food and Drug Administration (FDA) has published draft recommendations to revise its voluntary Pre-Investigational Device Exemption (Pre-IDE) program. To include 510(k) premarket notification and Humanitarian Device Exemptions in addition to Investigational Device Exemptions. Posted by Marta G. Zanchi. AAMI / FDA meetin...

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medinnovo.blogspot.com

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medinnovo: August 2011

http://medinnovo.blogspot.com/2011_08_01_archive.html

Bits of information from Marta Gaia Zanchi on the latest in medical innovation and in Medinnovo. Wednesday, August 31, 2011. California: September events on wireless health. On September 14th, I will be at the IEEE ComSoC Santa Clara Valley Chapter Meeting. On September 23rd, I will attend the USC Body Computing Conference. September 25th will mark the start of the Health 2.0. While I will not be attending, unfortunately, the Medicine 2.0. Posted by Marta G. Zanchi. Wednesday, August 24, 2011. New paymen...

2

medinnovo: De Novo: industry experience and latest FDA's initiatives

http://medinnovo.blogspot.com/2011/10/de-novo-industry-experience-and-latest.html

Bits of information from Marta Gaia Zanchi on the latest in medical innovation and in Medinnovo. Thursday, October 20, 2011. De Novo: industry experience and latest FDA's initiatives. The results of the Northwestern Survey on the FDA’s 510(k) regulatory clearance process. Launched in January 2011 to improve the predictability, consistency and transparency of the agency's pre-market review programs. More recently, on October 14, 2011, Representative Brian Bilbray introduced H.R. 3203, the “ ...Electromagn...

3

medinnovo: September 2011

http://medinnovo.blogspot.com/2011_09_01_archive.html

Bits of information from Marta Gaia Zanchi on the latest in medical innovation and in Medinnovo. Friday, September 23, 2011. Tipping point of wireless health. Today at the Body Computing Conference 5.0 at the University of Southern California, Los Angeles, a great panel moderated by Don Jones, Vice President of Business Development / Wireless Health at Qualcomm, opened the conversations on wireless medical devices by sharing their opinions on the “tipping point” for wireless health. Daniel Kraft, Executi...

4

medinnovo: Paul E. Jacobs: wireless health 2011 keynote

http://medinnovo.blogspot.com/2011/10/paul-e-jacobs-wireless-health-2011.html

Bits of information from Marta Gaia Zanchi on the latest in medical innovation and in Medinnovo. Tuesday, October 11, 2011. Paul E. Jacobs: wireless health 2011 keynote. At Wireless Health 2011, Qualcomm Chief Executive Officer Paul E. Jacobs spoke today about Qualcomm's vision and initiatives in Wireless Health. For the reading pleasure of those who could not be in San Diego, I transcribed his keynote speech. Enjoy! Paul E. Jacobs: Wireless Health 2011 Keynote. Healthcare is a critical global issue....

5

medinnovo: October 2011

http://medinnovo.blogspot.com/2011_10_01_archive.html

Bits of information from Marta Gaia Zanchi on the latest in medical innovation and in Medinnovo. Thursday, October 20, 2011. De Novo: industry experience and latest FDA's initiatives. The results of the Northwestern Survey on the FDA’s 510(k) regulatory clearance process. Launched in January 2011 to improve the predictability, consistency and transparency of the agency's pre-market review programs. More recently, on October 14, 2011, Representative Brian Bilbray introduced H.R. 3203, the “ ...At Wireless...

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medinnovo.blogspot.com

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Bits of information from Marta Gaia Zanchi on the latest in medical innovation and in Medinnovo. Thursday, July 26, 2012. Pre-IDE program revision, one step towards predictability. The US Food and Drug Administration (FDA) has published draft recommendations to revise its voluntary Pre-Investigational Device Exemption (Pre-IDE) program. To include 510(k) premarket notification and Humanitarian Device Exemptions in addition to Investigational Device Exemptions. Posted by Marta G. Zanchi. AAMI / FDA meetin...

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