Former @US_FDA Reviewer šŗšø Biomedical Engineer š Opinions are my own
San Francisco, CA
Joined May 2019
- Tweets205
- Following729
- Followers278
- Likes884
I'm hiring! The ļ£æHealth US Regulatory Team is looking for a regulatory affairs expert to help us drive strategy and submissions for health products.
#regulatoryaffairs #fda #medtech #digitalhealth
jobs.apple.com/en-us/detailsā¦
Sam Surette retweeted
We are honored to be named to the #AI100 list of the most promising private #AI companies in the world ā thank you, @CBinsights! #HealthTech #ultrasound #POCUS cbinsights.com/research/repoā¦
Sam Surette retweeted
BREAKING: @Amazon just got an emergency use authorization from @US_FDA for a Covid-19 PCR test.
fda.gov/media/147050/downloaā¦
Sam Surette retweeted
Question from @anitakumar01 on lack of an FDA Commissioner nominee from Biden.
@PressSec says: "There sometimes is a journey on personnel and determining who the right person is for the job ... it's a priority but I don't have an update for you on when he will nominate someone."
Other than the headline, this is a great piece by @NicoleWetsman on how FDA decides 510(k) eligibility. It really boils down to whether new device has:
- same intended use
- same *types* of S&E questions
In the case of @clue it clearly met both criteria.
I agree with @nathancortez that it's an "old regulatory approach applied to very new types of products", but what is sometimes forgotten is that there have *always* been new types of products FDA has had to figure out how to regulate.
Sam Surette retweeted
ICYMI: AI-guided echocardiography allowed nurses to obtain echo images diagnostic of LV size and function, RV size, and presence of pericardial effusion. Full details in image and at ja.ma/3qVd8I6!
@JamesDThomasMD1 @AkhilNarangMD @NMCardioVasc
Sam Surette retweeted
Thank you, @FierceMedTech, for selecting Caption Health as one of this year's #Fierce15! We're honored to be recognized for our efforts in creating, validating & delivering a solution for one of healthcareās most pressing problems: access to quality care. fiercebiotech.com/special-reā¦
Sam Surette retweeted
"Artificial intelligence can extend the reach of echocardiography to assess the 4 basic parameters of left ventricular size and function, right ventricular size, and presence of a nontrivial pericardial effusion to sites with limited expertise." jamanetwork.com/journals/jamā¦
Sam Surette retweeted
Reported #COVID19 deaths in the U.S. vs. all published IHME projections. #pandemic #dataviz
Source: reddit.com/r/dataisbeautifulā¦
Sam Surette retweeted
A great example of @DCVC portfolio co @CaptionHealth
bending the cost curve down for better cardiac care in COVID19 impacted ICUs
Many thanks for featuring our real-world experience in @JACCJournals Case Reports, @JGrapsa!
We also published the results of our multicenter trial in @JAMACardio this week! jamanetwork.com/journals/jamā¦
Sam Surette retweeted
š Image capture looks better than mine as a fellow
šš½Congrats @AkhilNarangMD @JamesDThomasMD1 and team!!
We are šŖ together
AI + cardiology teams = ā¬ļø Access and #heartsuccess #cardiotwitter
Delighted to report publication of our @CaptionHealth pivotal trial in @JAMACardio for AI-guided #EchoFirst by novices. 8 nurses scanned 30 pts each w/ dx LV size&fxn in 98.8%. jamanetwork.com/journals/jamā¦ @NMCardioVasc @EricTopol @David_Ouyang @ASE360 @AkhilNarangMD @robertomlang
Sam Surette retweeted
āArtificial intelligence can extend the reach of echocardiography to assess the 4 basic parameters of left ventricular size and function, right ventricular size, and presence of a nontrivial pericardial effusion to sites with limited expertise.ā HT @David_Ouyang
Delighted to report publication of our @CaptionHealth pivotal trial in @JAMACardio for AI-guided #EchoFirst by novices. 8 nurses scanned 30 pts each w/ dx LV size&fxn in 98.8%. jamanetwork.com/journals/jamā¦ @NMCardioVasc @EricTopol @David_Ouyang @ASE360 @AkhilNarangMD @robertomlang
Sam Surette retweeted
Exciting developments in AI for echocardiograms and ultrasound! Congratulations to the team!
Delighted to report publication of our @CaptionHealth pivotal trial in @JAMACardio for AI-guided #EchoFirst by novices. 8 nurses scanned 30 pts each w/ dx LV size&fxn in 98.8%. jamanetwork.com/journals/jamā¦ @NMCardioVasc @EricTopol @David_Ouyang @ASE360 @AkhilNarangMD @robertomlang
Sam Surette retweeted
This is a great example of a well run study that led to breakthrough de novo authorization. Also a great example of the transparency we get for ML/AI products that go through the FDA.
Ecstatic to see our research published in @JAMACardio today! This study was the primary basis for last year's De Novo authorization of our breakthrough AI-guided image acquisition software.
jamanetwork.com/journals/jamā¦
š
A new AI program provides turn-by-turn instructions so non-specialist operators (eg nurses) can obtain TTE images. In this study expert echocardiographers judged the views diagnostic for LV size & function, RV size, pericardial effusion ja.ma/2OGVSYG
Ecstatic to see our research published in @JAMACardio today! This study was the primary basis for last year's De Novo authorization of our breakthrough AI-guided image acquisition software.
jamanetwork.com/journals/jamā¦
Sam Surette retweeted
Thanks, Sam. Great collaboration between @NMCardioVasc and @NMPulmCritCare to bring AI-guided echoes to the COVID ICU. Amazing range of diagnoses that can be made. Many thanks to @ppsengupta1 for great editorial. @EricTopol @David_Ouyang @CaptionHealth #EchoFirst @ASE360
Case studies illustrating use of Caption AI at the point of care in the COVID-19 ICU were published today in JACC Case Reports!
@JACCJournals @JCheemaMD @AkhilNarangMD @JamesDThomasMD1
sciencedirect.com/science/arā¦
Case studies illustrating use of Caption AI at the point of care in the COVID-19 ICU were published today in JACC Case Reports!
@JACCJournals @JCheemaMD @AkhilNarangMD @JamesDThomasMD1
sciencedirect.com/science/arā¦