How 'bout that new law suit ladies

[Anonymous]

The ongoing DOJ/FDA investigation of Masimo was also discussed during Q2 Earnings Call in August:

CEO Kiani & CFO de Raad: "The [federal grand jury subpoena/investigation] may be a distraction to management and cause us to incur significant expenses, and could result in criminal, civil or regulatory proceedings against us, our officers and/or other employees."
Masimo 10-Q SEC filing, p.50
http://www.sec.gov/Archives/edgar/data/937556/000093755614000138/masi-20140927x10q.htm

Mark de Raad: "Legal expenses associated with responding to the [federal grand jury subpoena/iinvestigation] in particular have been difficult to predict. And as a result, we are now anticipating that we will need to incur an additional $5 million in legal expenses [for a total of $10 million] related to this matter throughout the rest of 2014."
Q2 2014 earnings call, Aug 7, 2014
http://m.seekingalpha.com/article/2...script?source=email_rt_article_readmore&app=1

Joe Kiani: "Our ability to see some of the earnings per share leverage in 2014 had been and will unfortunately continue to be impacted by the higher-than-usual legal expenses resulting primarily from the [federal grand jury subpoena/investigation]. In fact, of our new projected $289 million of fiscal 2014 GAAP operating expenses, approximately $10 million is related to this topic, which was absent in our expenses last year. We hope that these investment issues will be concluded soon but cannot estimate a completion date at this time."
Q2 2014 earnings call, Aug 7, 2014
http://m.seekingalpha.com/article/2...script?source=email_rt_article_readmore&app=1

Let's keep that out of sight out of mind please. Joker n' co would prefer we focus on the good and deny the bad.

 

[Anonymous]

The ongoing DOJ/FDA investigation of Masimo was also discussed during Q2 Earnings Call in August:

CEO Kiani & CFO de Raad: "The [federal grand jury subpoena/investigation] may be a distraction to management and cause us to incur significant expenses, and could result in criminal, civil or regulatory proceedings against us, our officers and/or other employees."
Masimo 10-Q SEC filing, p.50
http://www.sec.gov/Archives/edgar/data/937556/000093755614000138/masi-20140927x10q.htm

Mark de Raad: "Legal expenses associated with responding to the [federal grand jury subpoena/iinvestigation] in particular have been difficult to predict. And as a result, we are now anticipating that we will need to incur an additional $5 million in legal expenses [for a total of $10 million] related to this matter throughout the rest of 2014."
Q2 2014 earnings call, Aug 7, 2014
http://m.seekingalpha.com/article/2...script?source=email_rt_article_readmore&app=1

Joe Kiani: "Our ability to see some of the earnings per share leverage in 2014 had been and will unfortunately continue to be impacted by the higher-than-usual legal expenses resulting primarily from the [federal grand jury subpoena/investigation]. In fact, of our new projected $289 million of fiscal 2014 GAAP operating expenses, approximately $10 million is related to this topic, which was absent in our expenses last year. We hope that these investment issues will be concluded soon but cannot estimate a completion date at this time."
Q2 2014 earnings call, Aug 7, 2014
http://m.seekingalpha.com/article/2...script?source=email_rt_article_readmore&app=1

Yet the only questions re: MASI's "headwinds" I've ever known joker to discuss publicly tend to be superficial nuances of little or no real threat to MASI's bottom line. He permits analysts and media reporters for example, to ask about challenges that are of no fault of his own or his company's, like product knock-offs flooding the market, reconditioned sensors that affect his business. He'll also field questions about the challenges facing all med tech companies, not just his own, like the impact of the affordable care act or medical excise tax, etc. Neither of which hold a candle to MASI's self-imposed headwinds, i.e. DOJ & FDA ordeals, in terms of potential threat to the company's reputation and financial stability and future.

Masi's Q4 earnings call is in two more weeks (2/17). Whatever you do, DON'T EXPECT any hint of a discussion on that call about the strongest headwinds right now facing Masimo and its CEO Joe Kiani. Do however expect a pre-choreographed, time-sucking Q&A session to highlight joker's selfless commitment to patient safety and healthcare, and his humble plan to save the world.

 

[Anonymous]

Just ask joker. He'll have three months to craft a response with his analysts.

Tao Levy - Wedbush
David Clair - Piper Jaffray
Joanne Wuensch - BMO Capital Market
Brian Weinstein - William Blair
Matthew Larew - William Blair
Matthew Dodds - Citigroup
Chris Lewis - Roth Capital Partners
Larry Keusch - Raymond James
Ben Haynor - Feltl and Company

any analyst changes since oct? otherwise here's the lineup for q4 call,
will be asking the approved Qs to Kiani & de Raad.

 

[Anonymous]

any analyst changes since oct? otherwise here's the lineup for q4 call,
will be asking the approved Qs to Kiani & de Raad.

Somebody needs to ask Kiani and de Raad why there are so many (Masimo) parameter applications still tied up at the FDA awaiting approvals after so many months--well beyond average wait times. Ever since the FDA Warning Letter was issued to Masimo in August, no parameters have been cleared or approved, and I'd like to hear some reassurance from Kiani & de Raad about Masimo's ability to comply with, and successfully get new parameters cleared or approved by, the FDA in the near future (or ever)?

Here is a partial list of Masimo technologies that have unsuccessfully been submitted for FDA clearance. Some may have received non-domestic clearances, i.e. CE Mark, for use outside the United States: Eve newborn screening, ORI oxygen reserve index, Spf02, Halo, SpHb DCI Mini, TFA-1 Transflectance forehead sensor, 03 Regional Oxymetry...

Go Seahawks!

 

[Anonymous]

Somebody needs to ask Kiani and de Raad why there are so many (Masimo) parameter applications still tied up at the FDA awaiting approvals after so many months--well beyond average wait times. Ever since the FDA Warning Letter was issued to Masimo in August, no parameters have been cleared or approved, and I'd like to hear some reassurance from Kiani & de Raad about Masimo's ability to comply with, and successfully get new parameters cleared or approved by, the FDA in the near future (or ever)?

Here is a partial list of Masimo technologies that have unsuccessfully been submitted for FDA clearance. Some may have received non-domestic clearances, i.e. CE Mark, for use outside the United States: Eve newborn screening, ORI oxygen reserve index, Spf02, Halo, SpHb DCI Mini, TFA-1 Transflectance forehead sensor, 03 Regional Oxymetry...

Go Seahawks!

Keep dreaming.That's not an approved question.

 

[Anonymous]

Masimo was worth more 8 years ago after going public in 2007 than they're worth today. With a mere fraction of its current product portfolio the company's stocks were an eye-popping $40/share. But it's been a downward yo-yo ride ever since. I can't remember the last time shares were above $30. Fortunately, a company's reputation and ability to instill faith & confidence in it's future affects stock value--in a big way. Draw your own conclusions.
http://www.massdevice.com/features/masimo-ceo-joe-kiani-medicine-chooses-you

You can say Yo-yo ride, we prefer downward trending
Either way leadership transfusion is the answer

 

[Anonymous]

Somebody needs to ask Kiani and de Raad why there are so many (Masimo) parameter applications still tied up at the FDA awaiting approvals after so many months--well beyond average wait times. Ever since the FDA Warning Letter was issued to Masimo in August, no parameters have been cleared or approved, and I'd like to hear some reassurance from Kiani & de Raad about Masimo's ability to comply with, and successfully get new parameters cleared or approved by, the FDA in the near future (or ever)?

Here is a partial list of Masimo technologies that have unsuccessfully been submitted for FDA clearance. Some may have received non-domestic clearances, i.e. CE Mark, for use outside the United States: Eve newborn screening, ORI oxygen reserve index, Spf02, Halo, SpHb DCI Mini, TFA-1 Transflectance forehead sensor, 03 Regional Oxymetry...

Go Seahawks!

Don't forget the Mar 2014 Pronto-7 rejection that has yet to reresolved since last March. Details in Maimo 10-Q filing (4/14) reports Masimo's failure to get 510(K) clearance from the FDA on an improved Pronto-7 device...

"In connection with our most recent FDA 510(k) filing for certain improvements to our Pronto-7® product, the FDA expressed concerns and requested additional information regarding the methods we used to validate the SpHb® parameter. We responded to the FDA’s request for additional information on March 25, 2014. The FDA responded that the remaining issues would not likely be resolved in the time remaining, so we voluntarily withdrew the application on March 31, 2014. We intend to work with the FDA to address whatever remaining concerns the agency has, but we cannot be sure we will be able to resolve those concerns."
http://www.investors.com/et/dfs/2014/937556/0000937556-14-000072/masi-20140329x10q.HTM

 

[Anonymous]

Don't forget the Mar 2014 Pronto-7 rejection that has yet to reresolved since last March. Details in Maimo 10-Q filing (4/14) reports Masimo's failure to get 510(K) clearance from the FDA on an improved Pronto-7 device...

"In connection with our most recent FDA 510(k) filing for certain improvements to our Pronto-7® product, the FDA expressed concerns and requested additional information regarding the methods we used to validate the SpHb® parameter. We responded to the FDA’s request for additional information on March 25, 2014. The FDA responded that the remaining issues would not likely be resolved in the time remaining, so we voluntarily withdrew the application on March 31, 2014. We intend to work with the FDA to address whatever remaining concerns the agency has, but we cannot be sure we will be able to resolve those concerns."
http://www.investors.com/et/dfs/2014/937556/0000937556-14-000072/masi-20140329x10q.HTM

Sphb can't get a break

 

[Anonymous]

Sphb can't get a break

Fen-Phen didn't get one either

 

[Anonymous]

Somebody needs to ask Kiani and de Raad why there are so many (Masimo) parameter applications still tied up at the FDA awaiting approvals after so many months--well beyond average wait times. Ever since the FDA Warning Letter was issued to Masimo in August, no parameters have been cleared or approved, and I'd like to hear some reassurance from Kiani & de Raad about Masimo's ability to comply with, and successfully get new parameters cleared or approved by, the FDA in the near future (or ever)?

Here is a partial list of Masimo technologies that have unsuccessfully been submitted for FDA clearance. Some may have received non-domestic clearances, i.e. CE Mark, for use outside the United States: Eve newborn screening, ORI oxygen reserve index, Spf02, Halo, SpHb DCI Mini, TFA-1 Transflectance forehead sensor, 03 Regional Oxymetry...

Go Seahawks!

Since the warning letter, Masimo has only managed to get certain hardware cleared.
But no parameters. None. Zero.

Radius-7 wireless wearable pt monitor - fda cleared 12/1/14
ISA OR+ multigas monitoring module - fda cleared 12/16/14

 

[Anonymous]

Since the warning letter, Masimo has only managed to get certain hardware cleared.
But no parameters. None. Zero.

Radius-7 wireless wearable pt monitor - fda cleared 12/1/14
ISA OR+ multigas monitoring module - fda cleared 12/16/14

Good for me good for you good for humanity

 

[Anonymous]

Sphb can't get a break

Neither did Optigrab
https://m.youtube.com/watch?v=qaz2hxZLycY

 

[Anonymous]

Neither did Optigrab
https://m.youtube.com/watch?v=qaz2hxZLycY

I'd rather have an optigrab than a pronto

 

[Anonymous]

Since the warning letter, Masimo has only managed to get certain hardware cleared.
But no parameters. None. Zero.

Radius-7 wireless wearable pt monitor - fda cleared 12/1/14
ISA OR+ multigas monitoring module - fda cleared 12/16/14

Pez dispensers and SkyMall trinkets are FDA cleared too. Anyone with an application fee and 30 days can get hardware cleared...with or without a spotty compliance record such as masimo's.

 

[Anonymous]

Pez dispensers and SkyMall trinkets are FDA cleared too. Anyone with an application fee and 30 days can get hardware cleared...with or without a spotty compliance record such as masimo's.

Simply amazing... This company with the "spotty safety compliance record" remains staunchly in denial about it, reppresenting itself and CEO time and time again as advocate and protector of patients. Don't they realize people know the truth? Or are they just trying to hang on to those few who don't yet? I'm stumped on this one.

 

[Anonymous]

Simply amazing... This company with the "spotty safety compliance record" remains staunchly in denial about it, reppresenting itself and CEO time and time again as advocate and protector of patients. Don't they realize people know the truth? Or are they just trying to hang on to those few who don't yet? I'm stumped on this one.

Chill. Won't you please sit back and enjoy the fiery crash.

 

[Anonymous]

Yet the only questions re: MASI's "headwinds" I've ever known joker to discuss publicly tend to be superficial nuances of little or no real threat to MASI's bottom line. He permits analysts and media reporters for example, to ask about challenges that are of no fault of his own or his company's, like product knock-offs flooding the market, reconditioned sensors that affect his business. He'll also field questions about the challenges facing all med tech companies, not just his own, like the impact of the affordable care act or medical excise tax, etc. Neither of which hold a candle to MASI's self-imposed headwinds, i.e. DOJ & FDA ordeals, in terms of potential threat to the company's reputation and financial stability and future.

Masi's Q4 earnings call is in two more weeks (2/17). Whatever you do, DON'T EXPECT any hint of a discussion on that call about the strongest headwinds right now facing Masimo and its CEO Joe Kiani. Do however expect a pre-choreographed, time-sucking Q&A session to highlight joker's selfless commitment to patient safety and healthcare, and his humble plan to save the world.

Clever of MASI to finger universal "headwinds" facing the co to analysts, shareholders, investors and the media... offering no discussion of the more threatening ones in play. Why risk the anxiety? Smart.

Reported by Zacks on behalf of Masimo...
"Reluctance of hospitals on buying new technology remains a major headwind. Moreover, the monitoring products market remains quite competitive with a lot of companies vying for substantial market share."
http://www.zacks.com/stock/news/159508/masimo-launches-mightysat-pulse-oximeter-for-personal-use

 

[Anonymous]

Clever of MASI to finger universal "headwinds" facing the co to analysts, shareholders, investors and the media... offering no discussion of the more threatening ones in play. Why risk the anxiety? Smart.

Reported by Zacks on behalf of Masimo...
"Reluctance of hospitals on buying new technology remains a major headwind. Moreover, the monitoring products market remains quite competitive with a lot of companies vying for substantial market share."
http://www.zacks.com/stock/news/159508/masimo-launches-mightysat-pulse-oximeter-for-personal-use

last year's icy weather back east is still taking its toll
Don't laugh! Joker said it not me.

 

[Anonymous]

Social media is like a free million-watt amplifier for your reputation.
The good news is...it gets the word out on your ass fast!
The bad news is....it gets the word out on your ass fast!

 

[Anonymous]

Sphb can't get a break

Latest research on SpHb (Dec 2014) agrees with "other research" on SpHb.... DON'T RELY ON IT when making transfusion decisions.

Title of study: Trending, Accuracy, and Precision of Noninvasive Hemoglobin Monitoring During Human Hemorrhage and Fixed Crystalloid Bolus.
Shock; Marques NR, et al, Dec 2014
http://www.ncbi.nlm.nih.gov/m/pubmed/25521537/

Conclusion of study: "Accuracy was similar to other studies and therefore the use of [Masimo's SpHb] alone is likely insufficient to make transfusion decisions."