This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by former FDA branch chief and regulatory expert David Pudwill, aka Mr. Regulatory, for a packed conversation covering AI-enabled diagnostics, pediatric devices, drug shortages, biocompatibility, cybersecurity, and some unusually useful FDA website updates.

David reflects on nine years at the FDA, including his time in the Office of Legislation helping prepare agency leaders for congressional testimony. He also previews his upcoming RAPS presentation on drug shortages, including efforts to reshore heparin manufacturing and strengthen access to critical medications such as midazolam.

The team digs into Powerful Medical’s Queen of Hearts AI ECG model, which received De Novo authorization for identifying STEMI and STEMI-equivalent patterns in patients with suspected acute coronary syndrome. Unlike many AI tools discussed on TTKU, this one supports time-critical decisions where minutes can matter.

They also celebrate two pediatric device developments: Trexo Robotics’ Theo wearable robotic exoskeleton, which recently received 510(k) clearance after a previous FDA warning letter, and Neola Medical’s Breakthrough Device Designation for a non-invasive continuous lung monitoring system designed for premature infants.

Additional topics include:

• New FDA biocompatibility resources

• Small Business Determination updates

• Updated AI, AR/VR, and digital health device databases

• Clear dental aligner information

• Why some Q-Subs don’t appear in the Customer Collaboration Portal tracker

• Two competing De Novos granted on the same day

• Boston Scientific’s cybersecurity incident

• Annie Saha’s departure after 20+ years at the FDA

• What exactly is happening on the FDA’s Instagram account

Plus: elephant jokes, regulatory nostalgia, and plenty of dad-joke expertise.

Links & Resources

• Powerful Medical’s AI heart attack detection model secures FDA approval

• Trexo Robotics Receives FDA Clearance; Launches Trexo Theo, First Pediatric Robotic Exoskeleton Cleared for Home Use

• Neola Medical Receives FDA Breakthrough Device Designation

• Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program

• Clear Dental Aligners

• Biocompatibility Assessment Resource Center

• Glossary of Biocompatibility Terms

• What Should I Put in a Test Report?

• Artificial Intelligence-Enabled Medical Devices

• Augmented Reality and Virtual Reality in Medical Devices

• Medical Devices that Incorporate Sensor-based Digital Health Technology

• Boston Scientific’s Update on Recent Cybersecurity Incident

Connect

• Allison Komiyama, PhD, RAC, FRAPS | https://www.linkedin.com/in/allisonkomiyama/ | https://www.bluestocking.health/

• Michael Nilo, MS | https://www.linkedin.com/in/michaelnilo/ | https://www.nilomedicalconsulting.com/

• David Pudwill | https://www.linkedin.com/in/david-pudwill/ | https://crossject.com/en/ | https://fdablueprint.com/ | https://mrregulatory.com/ | https://pratherbiomedical.com/