How 'bout that new law suit ladies

Missed a few...(Masimo's logjam of 510(K) applications hung up at FDA still awaiting approval):

Eve newborn screening (CE Mark 10/10/14)
ORI oxygen reserve index (CE Mark Oct 2014)
Spf02 fractional arterial O2 sat (CE Mark Oct 2012)
Halo Index (CE Mark Oct 2010)
SpHb DCI Mini (CE Mark 8/28/14)
TFA-1 Transflectance forehead sensor (CE Mark 6/25/14)
03 Regional Oximetry (CE Mark 1/23/14)
RRp - Respiration Rate thru pleth waveform (CE Mark early 2011)
Universal Resposable SuperSensor (CE Mark 10/12/12)

 

Just like joker--cheap with a flexible sole.

 

Cheap with a flexible sole--qualities indicative of the manufacturer.

 

No better gift than a pair of white Masimo loafers w/ cheap price & flexible sole.
https://www.youtube.com/watch?v=YtSvWYtpd50

 

no better gift
https://www.youtube.com/watch?v=YtSvWYtpd50

 

I find the outcomes of these studies concerning, given the availability of Masimo’s Rad-57 SpCO monitors for purchase/use on patients.

"The US Department of Defense Military Health System selects the Masimo Rad-57 Handheld Pulse CO-Oximeter as the military's standardized handheld pulse oximeter for use worldwide."

Masimo CEO Joe Kiani: "The best place for our soldiers to be is safe at home. But when they are in harm's way, we want to be there for them. We are honored our life-saving technology will be with them to help them come home."
http://www.prohealthservicezone.com/News_Detail_Us_military_opts_for_masimo_rad-57s_handheld_pulse_co-oximeter_9594.asp#ixzz3VTNfX4b6

I can appreciate Kiani's regard for our soldiers, and hope the US Department of Defense Military Health System requires redundancy of COHb/lab measurements to complement Rad-57 SpCO readings when directing triage or patient management.

 

Masimo has been attempting for years to integrate multi-parameter (and/or multi-vendor) "interoperable" algorithms that could in theory better-predict patients' aggregate health states. Below is an example from 2011, integrating >10 non-invasive parameters between two manufacturers (Masimo & BMEYE) into a single index number the companies refer to as "DO2I"or oxygen delivery. This technology nor any of Masimo's multi-vendor integrated algorithms/indexes have yet been approved by the FDA for distribution in the US.

Title: “New Algorithms Offered in ccNexfin Combined With Noninvasive Beat-to-beat Cardiac Output (CO), Blood Pressure (BP) and Masimo's Breakthrough Noninvasive Hemoglobin (SpHb) and Oxygen Saturation (SpO2) Measurements”
CNW Newswire, 6/14/11
http://www.newswire.ca/en/story/770075/bmeye-launches-a-noninvasive-breakthrough-parameter-for-delivery-of-oxygen-do2i-and-new-fluid-management-parameters-at-the-european-society-of-anesthe

“Masimo Rainbow SET and BMEYE ccNexfin offers a totally noninvasive method of providing some of the most advanced cardiovascular and hemodynamic monitoring capabilities available today. It utilizes a BMEYE finger cuff to capture and continuously measure beat-to-beat blood pressure, mean arterial pressure (MAP), cardiac output (CO), stroke volume (SV), systemic vascular resistance (SVR), dynamic fluid responsiveness parameters (PPV, SVV), index of contractility (dP/dt) and a Masimo finger sensor to noninvasively and continuously measure hemoglobin (SpHb®), oxygen saturation (SpO2), and perfusion index (PI). The combined technologies provide the unique parameter oxygen delivery (DO2I).”
Masimo and BMEYE claim these integrated functional hemodynamic monitoring data “allow clinicians to predict and proactively address the early signs of hemodynamic instability during the peri-operative period and in critical situations.”

 

What other company does that--references favorable internal data to support their products, but doesn't make the data publically available? Why not?! Is there something about the internal study or the data itself that Masimo isn't proud of?

 

all is coming together...ain't it grand
Joker's highway, his algorithm...all he needs now is the world's patient data. So if you''ll please sign a pledge to share that with him ASAP
much appreciated thank you, I'm trying to win a fishing trip

 

scrub-a-dub dub
data processed in pj's tub
cherries picked, outliers plucked
Oh no! Our soldiers and WIC! They might be #ucked!

 

FYI, the Rad57 can be upgraded to rainbow now. (I don't have more confidence in it either way, just saying.)
http://www.masimo.com/rad-57/

 

In search of respect the obedient quack is limited to far away lands. Where there is language barrier there is hope...
http://md0.tech-ex.com/video/exh/cmef2011sp/masimo.html

 

Listen to him faithfully pitch SpHb with no conviction on his face. Maybe the "oh crap nobody believes me here either" look was lost in translation.

 

these findings don't surprise me in the least. SpCO algorithm includes SpHb measurement taken during test (whether sphb is reported separately on screen or not).
In other words the accuracy of SpCO greatly depends on accuracy of SpHb measurement
that is too vulnerable

 

Same is true of all Masimo's CO-Ox Hb fractions... Measured SpHb is factored into SpMet algorithm and SpOC (oxygen content), SpCO (carboxy), and a number of other funky index parameters the company markets... like SpfO2, Halo, DO2I (O2 delivery), etc. Since SpHb measurement is fundamental to all of these parameters/indexes, they're all subject to SpHb's limitations. Essentially, if the SpHb number is off, they're all off! Isn't that swell?

Please offer any insight on this if you have any. Does anyone know if SpHb measurement is also factored into PVI algorithm? Pretty sure it is.

 

MASI has so much riding on SpHb. No wonder they're fighting so hard to keep it legit.
Is a big domino.

 

Time somebody tip that baby over

 

and firefighters

 

EMS ethics violations involving Masimo Rad-57 contract. Please direct your questions or comments to the Masimo Ehics Foundation
Board of Directors:
Joseph Kiani, Chairman
James R. Bergman, Director
Mark P. de Raad, Director, Treasurer and Secretary
Frederick J. Harris, Director
Sarah Kiani, Director
http://www.masimofoundation.com/about/board-of-directors.htm

 

Note to self: some things must wait until AFTER contracts are signed! For example, accepting lofty honorariums & travel packages beforehand from tech companies looking to "create a business edge" for themselves may be deemed unethical.