FDA

5 statements across 4 episodes · 3 bullish · 0 bearish · 4 people on the record · first statement Apr 26, 2017 by Jim Sweeney · across every show →

Everything said about FDA, oldest first

Apr 26, 2017 bullish
Disclosure
Clarify Medical plans online direct-to-patient launch after FDA clearance
“We've developed a device and are seeking FDA clearance in the next few months. That will enable people to self-treat at home. Using a smart app, we're able to surveil what they're doing, prevent them from over-utilizing a device, communicate all of that inform…”
Jim Sweeney Apr 26, 2017 ▶ 3:15 641: He Has $25B In Medical Tech Exits, $2B Raised, He's Sitting On PhotoTherapy $1b+ Bet Now with CEO Jim Sweeney
Jul 16, 2017 positive
Assertion Contradicted
Segala: SFL Scientific's ML suite got Stanford client FDA approval
“So they basically hired us to build out this entire suite of AI machine learning product solutions, and we did that, and it actually got them through FDA regulations, right?”
Michael Segala Jul 16, 2017 ▶ 3:58 722: This Machine Learning Agency did $800k Last Year
Dec 28, 2021 bullish
Prediction Not checkable as stated
Clair Labs expects to secure its first paying customer in early 2023
“Early 20 23. Yes. Wow. Yeah. I mean, it's a long, no, no, no. It's because you need in order to realistically, not realistically, in order to make business reimbursement based business, not out of pocket business, reimbursement based business in healthcare in …”
Adi Berenson Dec 28, 2021 ▶ 18:36 HealthTech Device Prevents COPD Patients from Hospital Visits, $9m Raised, 50 Devices Shipped
Jun 16, 2022 neutral
Assertion Contradicted
FDA Had Zero Experience With Dental AI Before VideaHealth Applied
“When we went to the FDA, for instance, right, to get this cleared, like they never had any, They had no experience with dentists or dentistry whatsoever. They were familiar with like chest x-rays and mammography, right? You maybe have heard these algorithms fl…”
Florian Hill Jun 16, 2022 ▶ 8:47 How he Raised $20m+ to turn his College Thesis on Dental Data into a SaaS Company
Jun 16, 2022
Assertion Not checkable as stated
VideaHealth Monetized Insurer Claims Adjudication to Bypass FDA Delays
“One year ago we had revenue because we actually, we didn't talk about another side of a business, but we also work with insurance companies to automatically adjudicate their claims. And that doesn't require FDA approval.”
Florian Hill Jun 16, 2022 ▶ 16:51 How he Raised $20m+ to turn his College Thesis on Dental Data into a SaaS Company
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