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Post by agedhippie on Oct 1, 2020 17:51:41 GMT -5
Aged - Bluhale is a non-intrusive listening device. It does not replace the dreamboat and does not in anyway help in delivering the medication. What kind of trial are you looking for for what's basically a case you put the dreamboat in? If Bluhale is collecting data or used for dosing it's a medical device and requires approval. |
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Post by sayhey24 on Oct 1, 2020 18:42:54 GMT -5
Its not being used for dosing. The patient selects the dose and performs the dosing independent of the Bluhale. After the dosing has been completed Bluhale estimates how much was taken. The Bluhale is not a Class III device.
All MNKD needs is FDA clearance, not approval. The Apple watch is class II. I could make a pretty good argument for class I. In either case MNKD has more than enough study info to get clearance.
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Post by sportsrancho on Oct 1, 2020 19:54:53 GMT -5
I can understand it being used to dose TrepT but how could you use it to dose Afrezza when the dose is not aggressive enough as it is. It would just seem to reinforce the problem we have now. 🤷‍♀️ People do love gadgets though and they can see they’re getting all their powder.
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Post by rfogel on Oct 2, 2020 9:51:43 GMT -5
I'm disappointed. My initial impression was that the inhaler was "foolproof" -- any kind of breath would work. Now they're saying that the patient needs this additional device to "teach" them how to breath "properly"? Seem like that could discourage some.
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Post by sportsrancho on Oct 2, 2020 11:29:28 GMT -5
I'm disappointed. My initial impression was that the inhaler was "foolproof" -- any kind of breath would work. Now they're saying that the patient needs this additional device to "teach" them how to breath "properly"? Seem like that could discourage some. They don’t need it they just think they do because there’s powder left in the inhaler but Al accounted for that. |
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Post by mango on Oct 3, 2020 12:38:15 GMT -5
BluHale uses acoustic physics to detect inhalation technique and that data is manifested on a screen in real-time plotting the inhalation profile. Even in the consumer version, it just identifies the cartridge and is capable of being connecting via Bluetooth to other wireless devices like a CGM, etc...
It in no way effects dosing or inhalation, it is an attachment that does not interfere with administration.
A clinical trial for BluHale will be unnecessary. MannKind only needs FDA clearance.
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Post by goyocafe on Oct 4, 2020 9:50:54 GMT -5
No mention of BluHale at the virtual TCOYD booth on Saturday. You’d think something MC has talked about multiple times over the years would deserve more fanfare upon its general availability to practitioners. But it makes sense if it is still not available. This talk of requiring FDA approval to some degree or another has me thinking someone at MNKD left that step off the project plan and is just now getting to it.
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Post by Clement on Oct 4, 2020 11:27:36 GMT -5
Recently, at the Oppenheimer conference, MC said that BluHale Pro would launch in Q3 Q4 this year. BluHale Pro is for use in doctors' offices.
Previously, MC said that BluHale for consumers would be launched in 2021.
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Post by goyocafe on Oct 4, 2020 12:30:08 GMT -5
Recently, at the Oppenheimer conference, MC said that BluHale Pro would launch in Q3 Q4 this year. BluHale Pro is for use in doctors' offices. Previously, MC said that BluHale for consumers would be launched in 2021. When did he say Q3 Q4. First it was Q2 at the beginning of the year, then Q3 in Q2. Never heard it get pushed back again, but not surprised since it seems that is exactly what is happening. "BluHale you hear me talk a little bit about today, which is really about building connected care. We really see technology transforming healthcare and that our BluHale technology will really allow us to participate in that evolution of health care." "This is BluHale 1.0, which is BluHale PRO. This is a training device. This app has been updated now. It's loaded in the Apple Store and the Android operating system. And you can see here, because you proper inhalation, you get a green. If you do it wrong and this turns red. And here's the feedback, before training a patient, even a doctor's office was about 2 out of 5 in terms of confidence. When they leave our training program, they're almost a 4.8, 4.9 out of 5. So this really builds people's confidence along with understanding proper inhalation technique and holding a device -- loading the device. And then the future, we just gave you a picture here of, we'll be able to show you 2-hour postprandial drops when you take Afrezza really that tight control you're looking for, but having be able to have dose integration via BluHale into your CGM platform, we think is important into the future." seekingalpha.com/article/4375558-mannkind-corporation-mnkd-ceo-michael-castagna-presents-oppenheimer-fall-healthcare-life?part=single |
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Post by comnkd on Oct 6, 2020 7:43:19 GMT -5
Based on what goyocafe posted, the Bluehale device is a "force multiplier". It is a substitute for needing a knowledgeable trained clinician present to educate on the proper use of the inhaler. Perhaps newly prescribed Afrezza users will be loaned the device for a period of time. This would allow them to achieve best practices and find peace of mind/confidence with this paradigm shift in a shorter period of time. Just think back to the number of social media posts where the inhaler was incorrectly positioned. Bluehale should improve the rate of adoption and, more importantly, rate of retention. The tried and true sales adage.."It's easier to retain a customer than gain a new one." Once the heavy lifting is done, protect your investment. Seeing is believing and "I saw it again." mango |
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Post by yash on Oct 6, 2020 7:57:28 GMT -5
Countdown clock still moving?
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Post by goyocafe on Oct 6, 2020 9:14:47 GMT -5
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Post by goyocafe on Feb 25, 2021 10:22:21 GMT -5
Did I see that right, Bluehale available in Q1? I had a very high suspicion they hadn’t released it. Remember his original, modified, it’ll happen this time deadline? Click on the link for a trip down distant memory lane. |
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Post by itellthefuture777 on Feb 26, 2021 3:39:52 GMT -5
My guess is Bluehale can measure FEV-1 many times a day collecting real world data..electronically send that data and thereby remove the requirement to do a yearly fev1 as that has no real time or statistically valid value. A check up to show a once a year breath..rather know now and daily..all possible..so you do one fev1 then get a Bluehale..track in real time..no need to wait a year to see that your breathing is just as fine as it was before..just sayn..cost time saver..imo
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Post by blaz on Jun 17, 2022 14:38:58 GMT -5
First update I've seen in a longtime on the bluhale app, on Jun 9th 2022
"Added selection screen to choose what type of patient is being trained. Added color schemes based on type of patient being trained. Added contact information based on type of patient being trained"
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