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Final Software Approvals - September 2026

Field Value
Evidence type Controlled correspondence decision record
Respondents Camille Powe, MD; Tara Bresnahan, RN; Edward R. Damiano, PhD
Response dates 2026-09-03 through 2026-09-07 EDT
Email subject Bionic Loop Software - Final Approvals
Source retention Original email retained in project correspondence outside the software repository
Product impact Submission designation and document/process approval only; no software behavior change

Approved Items

The September 3 correspondence records approval of:

  1. BionicLoop 1.0 (843) for IDE submission;
  2. IFU-BL-001, revision 1.16, for IDE submission; and
  3. use of the recovery ZIP for CSV collection, transfer, and storage.

The approval closes the software-build and IFU selection decisions and the study-team approval of the ZIP/CSV operating approach. The approved study-data hierarchy remains Dexcom Clarity for CGM outcomes, the BionicLoop exported CSV for insulin-delivery outcomes, and staff-entered electronic case-report forms for adverse events and other safety information.

IFU Revision 1.17 Direction - 2026-09-04

Follow-on correspondence in the same email thread records:

  • Tara Bresnahan, RN supported applying the proposed IFU corrections; and
  • Camille Powe, MD directed the team to make the changes and submit IFU-BL-001 revision 1.17.

The approved revision corrects two Clinical Unlock section references, clarifies Pregnancy configuration terminology, records the revision 1.16 approval, replaces an internal build-tool instruction with controlled-document language, uses plain punctuation, and documents the existing built-in NOT FOR HUMAN USE badge displayed when no remote banner configuration is available. These are labeling and document-control corrections only; they do not change Build 843 software behavior.

Final Decision-Register Approvals - 2026-09-04 and 2026-09-07

In the same controlled email thread:

  • Tara Bresnahan, RN accepted D06, including the documented provisional residual-risk rating and completion of the controlled multi-G7 exercise before participant deployment rather than before IDE submission;
  • Tara Bresnahan, RN accepted D12, confirming CC-DEV as Build 843's supportive Scout service environment;
  • Tara Bresnahan, RN authorized Edward R. Damiano, PhD to provide final software-package approval under D11; and
  • Edward R. Damiano, PhD accepted the documented residual risks and known limitations (D07), Build 843 verification evidence and traceability (D08), and the documented cybersecurity scope and controls (D09). He also accepted the D11 designation and signed off on the final software package.

The source messages are dated September 4 and September 7, 2026 EDT. Original email is retained in project correspondence outside the software repository.

Final Device Labeling - 2026-09-04

The study-team submission folder contains 008_Device_Labeling.pdf, a 3-page, 230,910-byte final labeling file identifying BionicLoop 1.0 Build 843 and IFU-BL-001 revision 1.17 dated 2026-09-04. Software review verified SHA-256 561c4cd26171888454c27d2350162680a867190754a448fd4096d1dd8b10fe0c. This closes the document-handoff requirement tracked as D14.

Remaining Operational Work

The accepted D06 disposition retains the controlled multi-G7 exercise as a pre-deployment condition. Final IDE assembly, transfer, and submission remain under study-team control. Neither item changes the approved software package or reopens a software-package decision.