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Maintaining Momentum and Morale while Seeking FDA Approval l Build Mode

Surviving the long road to FDA approval isn’t just about building great technology, it’s about keeping your team motivated, finding the right investors, and learning how to operate when timelines are uncertain. This week on Build Mode, Isabelle Johannesen sits down with Robbie Bustami, co-founder and CEO of BioticsAI, a Startup Battlefield-winning company building an…

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Surviving the long road to FDA approval isn’t just about building great technology, it’s about keeping your team motivated, finding the right investors, and learning how to operate when timelines are uncertain.

This week on Build Mode, Isabelle Johannesen sits down with Robbie Bustami, co-founder and CEO of BioticsAI, a Startup Battlefield-winning company building an AI copilot for ultrasound to help detect fetal abnormalities. From a $100K prototype to FDA clearance, Robhy shares what it actually takes to build in one of the most regulated industries in the world.

In this episode, they break down what it really looks like to build a medtech startup, where you can’t “move fast and break things,” and every milestone takes time, coordination, and trust.

This conversation covers:

• How to stay motivated and keep your team aligned when FDA approval isn’t guaranteed

• What founders need to know about navigating the FDA process from day one How to find investors who understand the slower, high-risk nature of medtech

• Why cross-functional collaboration (engineers, clinicians, researchers) is critical to success

• The role of advisors and why active industry experts matter more than big names

• How to build momentum and celebrate wins during long, uncertain timelines

 Subscribe to Build Mode on Apple Podcasts () , Spotify () , or wherever you like to listen () . And watch the full videos on YouTube () .

Apply to Startup Battlefield: We are looking for early-stage companies that have an MVP. So nominate a founder (or yourself): techcrunch.com/apply () . Be sure to say you heard about Startup Battlefield from the Build Mode podcast.  

TechCrunch Disrupt: ([%E2%80%A6]pt2026&utm_content=ticketsales&promo=buildmode15&display=true) If you’re thinking about applying to Startup Battlefield, then October 13 to 15 in San Francisco, we’re back for TechCrunch Disrupt, where the Startup Battlefield 200 takes the stage. So if you want to cheer them on, or just network with 1000s of founders, VCs, and tech enthusiasts, then grab your tickets. ([%E2%80%A6]pt2026&utm_content=ticketsales&promo=buildmode15&display=true)  

Use code buildmode15 for 15% off any ticket type. 

Chapters:

00:00 Building a $100K MedTech Startup

00:32 Intro: Biotics AI & the Problem with Ultrasound Misdiagnosis

02:16 What Biotics AI Actually Does (AI Copilot for Ultrasound)

02:54 Early Days: Startup Battlefield & First Product

07:10 Navigating FDA Approval (Without Guesswork)

09:22 What FDA Clearance Unlocks (Going to Market)

10:59 Selling into Hospitals & Early Customers

12:11 Keeping a Team Motivated During Long Timelines

18:54 The Hardest Parts of Building in MedTech

22:22 Fundraising, Advisors, and Building the Right Team

28:33 The Future of AI in Reproductive Healthcare

New episodes of Build Mode () drop every Thursday. Hosted by Isabelle Johannessen. Produced and edited by Maggie Nye. Audience development led by Morgan Little. Special thanks to the Foundry and Cheddar video teams.

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CNET

Meet the ‘Landlords in the Stratosphere’

Stratospheric infrastructure company Sceye has crossed the Pacific for the first time, taking its reflective, balloon-like High-Altitude Platform System from New Mexico to Japan. It’s the latest milestone on the road to commercialization for a platform that can deliver phone service and observation. Read more about Sceye on CNET.com: 5G From the Sky: New Internet…

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Stratospheric infrastructure company Sceye has crossed the Pacific for the first time, taking its reflective, balloon-like High-Altitude Platform System from New Mexico to Japan. It’s the latest milestone on the road to commercialization for a platform that can deliver phone service and observation.

Read more about Sceye on CNET.com:
5G From the Sky: New Internet Infrastructure Takes Flight

Timecode Chapters:
0:00 Intro
0:26 A Fiber-Optic Cable from the Stratosphere
0:35 Latest Mission
1:27 Services Offered
2:00 Quantum Key Distribution
2:20 ‘Landlords in the Stratosphere’

Video Credits:
Host: Jesse Orrall
Scripted by: Jesse Orrall
Producer: Jesse Orrall, Jon Gomez
Camera: Sceye
Video Editor: Jon Gomez
Thumbnail Designer: Tharon Green

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#sceye #internet #stratosphere #infrastructure #broadband

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Science & Technology

This Robot Hit a 99.6% Success Rate

This robot achieved a 99.6% success rate over an eight-hour test. But when a single failure can stop an entire production line, how reliable do robots actually need to be? Mbodi co-founder Xavier Chi explains why reliability is one of robotics’ biggest real-world challenges on Build Mode. Watch the full episode:

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This robot achieved a 99.6% success rate over an eight-hour test. But when a single failure can stop an entire production line, how reliable do robots actually need to be?

Mbodi co-founder Xavier Chi explains why reliability is one of robotics’ biggest real-world challenges on Build Mode.

Watch the full episode:

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CNET

I Played With Apple’s New iPhones. Here’s What Surprised Me Most | One More Thing

Spending time with the iPhone Duo and iPhone 18 Pro has Bridget Carey rethinking what’s important in an iPhone upgrade. She breaks down the standout Duo features, what the crease is really like, and the questions she has for the future of Apple Watch and the next era of Apple. You can find the products…

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Spending time with the iPhone Duo and iPhone 18 Pro has Bridget Carey rethinking what’s important in an iPhone upgrade. She breaks down the standout Duo features, what the crease is really like, and the questions she has for the future of Apple Watch and the next era of Apple.

You can find the products mentioned in this video linked below
Apple iPhone 17, US Version, 256GB, eSIM, Mist Blue- Unlocked (Renewed)
*Cnet may get commission on this offer.

Read more about it on CNET.com
I Tried the iPhone 18 Pro’s New Deluxe Camera and Shot Photos With Starbursts
Planning to Get the iPhone Duo or iPhone 18 Pro? Turn Off This Setting on Your Old Device First

Timecode Chapters:
0:00 Apple’s new iPhone Tricks
0:14 Reporting from the iPhone Event at Apple Park
0:19 Opening and Closing the iPhone Duo
0:28 Big changes coming to iPhone
0:38 John Ternus has One More Thing
0:46 Bridget Carey’s iPhone Duo event experience
1:03 iPhone Duo
1:14 Taking video on iPhone Duo
1:37 Smart Take on iPhone Duo
2:04 Snoopy comes to iPhone Duo
2:21 iPhone Duo crease
2:41 Hidden camera behind iPhone Duo screen
2:51 iPhone Duo size
3:11 iPhone Duo cases
3:28 MagSafe on iPhone Duo
3:34 iPhone 18 Pro updates
4:07 Aperture on iPhone 18 Pro
4:42 Apple Watch changes
4:43 Apple Watch audio intelligence, recording, transcribing
5:20 New Apple Watch sensor
5:33 New Apple iPhone and Apple Watch accessories
5:47 One More Tip to help cover the cost of your new iPhone
5:56 Get the most money for your iPhone trade-in
6:18 Let us know in the comments what you want to see from One More Thing

Video Credits:
Host: Bridget Carey
Scripted by: Bridget Carey
Producer: Carly Marsh
Camera: Celso Bulgatti, Bridget Carey
Video Editor: Carly Marsh
Thumbnail Designer: Tharon Green

Add CNET as a trusted news source
Never miss a deal again! See CNET’s browser extension 👉
Check out CNET’s Amazon Storefront:
Subscribe to CNET on YouTube:
Follow us on TikTok:
Follow us on Instagram:
Follow us on Bluesky:
Like us on Facebook:
CNET’s AI Atlas:
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#iphone #apple #foldableiphone #iphoneduo

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