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THE TAPE

Epicenter picks five startups for ZeroTo510 and writes each a $25,000 check Autonomix puts Medtronic's former chief regulatory counsel on its board Science Corporation names Darius Shahida president as PRIMA starts selling in Europe CurvaFix puts a 1.45 percent removal rate on its first 3,800 pelvic implants FIZE Medical takes a first close on a $20M Series B with its Japanese distributor co-leading Catheter Precision takes LockeT past Brazil after six hospitals start using it FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA drafts a guided PMA submission template and sets a November 17 comment deadline Velosity buys Lucid Labs and adds more than 20 device engineers in Minnesota Epicenter picks five startups for ZeroTo510 and writes each a $25,000 check Autonomix puts Medtronic's former chief regulatory counsel on its board Science Corporation names Darius Shahida president as PRIMA starts selling in Europe CurvaFix puts a 1.45 percent removal rate on its first 3,800 pelvic implants FIZE Medical takes a first close on a $20M Series B with its Japanese distributor co-leading Catheter Precision takes LockeT past Brazil after six hospitals start using it FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA drafts a guided PMA submission template and sets a November 17 comment deadline Velosity buys Lucid Labs and adds more than 20 device engineers in Minnesota

Town hall

FDA holds a September 23 town hall on ISO 10993-18 extractions

MedDevice Startups Staff · 4 days ago · 2 min read · Via FDA town hall listing

CDRH holds a virtual town hall on chemical characterization testing for biocompatibility on September 23, from 1 to 2 p.m. Eastern. The subject is extraction methodology under ISO 10993-18 and the implementation problems FDA keeps seeing in submissions. Registration is not required and the session runs on Microsoft Teams.

The window for written questions closed August 26 at CDRH.Biocomp@fda.hhs.gov, and FDA will not take questions live. Slides go to CDRH Learn under Biocompatibility afterward.

FDA recognized ISO 10993-1:2025 only in part earlier this month and left clause 6.9 out. If your device needs chemical characterization, settle the extraction conditions before you pay a lab to run the study, because that choice is what the rest of the package rests on.

Questions & Answers

When is the FDA town hall on chemical characterization testing and extractions?

FDA holds the chemical characterization and extractions town hall on September 23, 2026, from 1 to 2 p.m. Eastern, on Microsoft Teams.

Do I need to register for the FDA September 23 biocompatibility town hall?

No. FDA says registration is not required for the September 23, 2026 chemical characterization town hall. Attendees join through the Microsoft Teams link on the FDA event page.

Can I ask FDA a question during the chemical characterization town hall?

No. FDA accepted written questions at CDRH.Biocomp@fda.hhs.gov until August 26, 2026, and will not take questions during the live September 23, 2026 session. Slides are posted to CDRH Learn afterward.

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