Top Tweets for #FDAprecert
仮にPre-Certのコンセプトが実現されれば、SaMDの開発から承認まで、FDAと密にコミュニケーションを取りながら短期間で完結出来るようなので、とても魅力的。その一方で、法改正の必要性や、大小企業の幅広い開発プロセスに対してどこまでカバー出来るのか等、不明点はまだまだ多い印象。#FDAprecert
@FDADeviceInfo just announced its #digitalhealth Center of Excellence setting the stage to "Empowering Digital health stakeholders to advance health care" Humbled and honored to be named the first founding Director. https://t.co/TQXq1Hwlra #digitalhealth #FDAprecert
This video does a great job of describing what #FDAPreCert is all about. Great job @_bakulpatel and team! Very proud of Tidepool’s involvement.
Tidepool is one of the first nine participants accepted into the @US_FDA's Digital Health Software Pre-Certification Program. Learn more about the program in this video: https://t.co/dGhyBbLPL6
Bonus!!! #FDAPrecert intentions and concept explained in a short overview video https://t.co/WoveIELK69 #digitalhealth @FDADeviceInfo
Update from FDA on #FDAPrecert on lessons learned and
next steps https://t.co/dKgEbPx87U @FDADeviceInfo #digitalhealth
Richard Huang, #MGH pathologist talking about the future of Digital Pathology in the context of #FDAPreCert, #digitalhealth and implications for @US_FDA regulations @HarvardMIT_CRS
.@Fitbit 4sale?, Is .@Google a #buyer~?!
🎣
#IT
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$FIT 📈
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ASK⤵️
@qatalystgroup @Zdov_ https://t.co/PqkhJfo3oZ
How Apple, Fitbit, Samsung and more are helping to modernize the FDA https://t.co/KZ2aBexBkZ
Our fearless leader, @howardlook, spoke with @MedTechDive about #TidepoolLoop, #FDAPrecert, and more. Give it a read! https://t.co/sxkBpYWrZO
@lucalazzarino @fitbit @parkjames Where’s the juice? $FIT #Fitbit
#LEADERSHIP - #Innovation - #mHealth - #DigitalHEALTH - #WearableTech - #Partnerships - #MedTech - #HealthTech - #BLoodPressure (Holy Grail) - #BP - #BloodSugar - #FDAPreCert (Updates) - #Therapeutics - #Coaching - RPM~
https://t.co/eXHUOgGTTX
The @US_FDA’s Software #FDAPreCert Program for #DigitalHealth is committed to a collaborative and transparent development process. Learn about the program’s progress, including relevant findings and outcomes of the testing so far. https://t.co/fMWrjNDbZD #MedicalDevice
Great recognition for @US_FDA efforts on digital health. Kudos to @_bakulpatel and the #FDAprecert team!
I’m humbled to be named in @StatNews’ five names to know in digital therapeutics. And congrats to my #digitalhealth team: “Experts say the U.S. regulators are way ahead of the game on digital therapeutics compared to their counterparts in Europe.”
Great three days talking #TidepoolLoop and #FDAPreCert with @_bakulpatel and @FDAcdrhIndustry teams. Great feedback and progress. Check out @Tidepool_org https://t.co/OpBtE76CaY Open and transparent FTW!
The FDA just announced an opportunity for companies to volunteer test cases for our Test Plan for the Software Precertification Program. Learn more https://t.co/rafODdoDTb
#digitalhealth #samd #fdaprecert
@_bakulpatel When considering a digital product, we must consider the safety and effectiveness. New tools, new regulatory paradigms. The FDA encourages you to publish your comments and feedback on the public docket 🙌 #FDAprecert https://t.co/YLHXiRWsiC #HarvardDigitalMed
@SGottliebFDA THANK YOU! for supporting and advancing the promise of #DigitalHealth and #FDAPreCert Your leadership enabled FDA to make tremendous progress. This Sunday tweetorial says it all
Join us tomorrow, Feb 7, for an #FDAPrecert user session! It's a chance to hear our team do a deep dive on the latest working model, test plan and regulatory framework. 1pm EST. https://t.co/SG85InLUzs
Attending #HIMSS2019? Please join me as I discuss #Tech4seniors (Mon 3:45pm, W208C), #FDAPrecert (Tues 10:30am, W314B), & #BrainHealth (Wed 3pm, W224H). Also, plz check-out Samsung’s #digitalhealthtech @SamsungPulse Lounge (W224H) #disruptiveinnovation https://t.co/V4snij6EyV
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