AEGIS
// LIFE SCIENCES
WORKBENCH/CASES/MEDTRONIC-ICM-001/06 MLR
3 BLOCKED · 41 IN REVIEW · CONTINUOUS
dev.krishnan@medtronic
STAGE 06 · MEDICAL · LEGAL · REGULATORY
3 promotional pieces blocked. 41 in active review. Hong Kong launch starts in 12 days.
⬢ THEMIS·promotional review agent·CONTINUOUS · NEVER SEALS·running since 12 May
∞
This stage never seals. THEMIS runs continuously for the full commercial life of LINQ-NEXT — every brochure, sales aid, conference booth, video, web page, social post, press release, and rep deck is reviewed claim-by-claim against the approved IFU and indication scope. Hard blocks (3 today) cannot be overridden by anyone; the asset must be edited to remove or substantiate the off-label claim.
208Total reviewed
164Approved
3Hard-blocked
3
Hard blocks
cannot ship
11
Changes requested
awaiting revision
27
In review
THEMIS · Dev pending
164
Approved 90d
live in market
2.3h
Median TAT
vs 5.2d pre-THEMIS
186
Approved claims
in claim library
✕
HARD BLOCK · CANNOT SHIP · OFF-LABEL
Korean cardiology conference booth video makes 2 off-label efficacy claims.
MLR-2026-0817 · THEMIS blocked at 17 May 14:22
Asset
KFDA cardiology conference booth video · 90 seconds · Korean
Channel
Conference · IDOMA-CARDIO 2026 · Seoul · 03-05 Jun
Owner
Mei Lin · Country GM APAC
Submitted
17 May 13:48 KST
Approved IFU
"AF detection in adults · ambulatory · stroke-history population"
Status
BLOCKED · 12 days before conference
THEMIS · Claim-by-claim verdict (8 claims reviewed)
Detects 95% of all clinically significant arrhythmias including AF, AV block, and VT
BLOCKED
Approved indication is AF detection only. AV block and VT detection are not within the approved Korean IFU scope. The pivotal trial (LINQ-NEXT, n=847) measured AF detection sensitivity as primary endpoint. AV block and VT were exploratory only. This phrasing implies efficacy across the broader arrhythmia class — off-label.
Source: MFDS approval letter · §3.1 · receipt c19d...3b87
Prevents up to 38% of recurrent strokes through earlier AF intervention
BLOCKED
Outcomes claim not supported. The 38% figure references a Reveal LINQ post-hoc analysis (Sanna 2014, CRYSTAL-AF). LINQ-NEXT measured AF detection sensitivity, not stroke prevention outcomes. Cannot claim outcomes for a device on outcomes data from a different device. PMDA explicitly rejected similar language in DEF-PMDA-2026-0117.
Source: LINQ-NEXT SAP §2.4 · approved CER v17 · no stroke prevention endpoint
Designed for the patient who cannot wait
CHANGES
Implies urgency / superiority without substantiation. Comparative urgency claim against external monitoring requires head-to-head data. Acceptable if reworded to non-comparative: "designed for continuous, long-term monitoring."
Continuous cardiac monitoring up to 4.5 years on a single insertion
APPROVED
Battery life claim aligns with locked technical specifications (battery file v4, receipt b811...3a92). 4.5 years is verified upper bound under standard use.
95.3% AF detection sensitivity in adults with cryptogenic stroke history
APPROVED
Exact match to approved CER v17 primary endpoint result. Population qualifier ("cryptogenic stroke history") is correct per Korean approved indication.
Policy invoked
POL-OFF-LABEL-BLOCK-V3 · policy://aegis.medtronic/mlr/off-label-block/v3
"Promotional content making efficacy claims outside the approved indication for the launch market is automatically blocked. Block cannot be lifted by any individual reviewer. Asset must be revised to remove the off-label claim or to add explicit substantiation that satisfies the indication scope. Off-label promotion to a regulated audience (HCPs, payers) triggers automatic regulatory notification within 5 business days per POL-REPORTABLE-EVENT-V2."
Block cannot be overridden · 2 claims must be removed or substantiated · regulatory notification clock: 5 days
By channel · last 90 days
208 reviewed
Sales aids · printed
64
Sales aids · iPad
49
Conference materials
34
Web pages · medtronic.com
23
HCP videos
18
Press releases
11
Social / LinkedIn
9
By owner · open queue
41 in review
Mei Lin · Country GM APAC
14
Marketing Tokyo
9
Marketing Seoul
7
Marketing Sydney
5
Marketing Singapore
4
Marketing Hong Kong
2
Verdict
Blocked3
Changes11
In review27
Approved164
Market
JP · Japan12
KR · Korea9
AU · Australia7
SG · Singapore5
TW · Taiwan4
HK · Hong Kong2
APAC · multi2
Channel
Sales aid17
Conference8
Video6
Web5
Press3
Social2
SLA
Overdue1
< 24h8
1-3 days14
> 3 days18
Sort: Verdict severity ↓
VIDEO
MLR-0817
CONFERENCE · BOOTH VIDEO · KOKorean cardiology conference booth · 90s · 2 off-label claims
KRMei LinBLOCKED
CONF 12d
submitted 17 May
PDF
MLR-0814
SALES AID · PRINTED · JAJapan rep brochure · "next-generation" superiority claim
Marketing TokyoBLOCKED
2d 18h
submitted 15 May
WEB
MLR-0809
WEB · HCP PORTAL · ENmedtronic.com/linq-next HCP page · stroke prevention efficacy claim
APACMarketing SGBLOCKED
4d 02h
submitted 13 May
PDF
MLR-0821
SALES AID · IPAD · ZH-TWTaiwan rep deck v3 · 14 slides · 38 claims to verify
TWMarketing TPEREVIEW
18h
submitted 18 May
PDF
MLR-0820
PRESS · APAC REGIONAL · ENHK launch press release · 22 May embargo
HKMei LinCHANGES
22h
submitted 17 May
VIDEO
MLR-0819
HCP VIDEO · 4-MIN · JATokyo training video · cardiologist Q&A · approved IFU walkthrough
Marketing TokyoREVIEW
2d 08h
submitted 16 May
PDF
MLR-0818
SALES AID · IPAD · KOKorean rep iPad detail aid v2 · payer talking points
KRMarketing SeoulCHANGES
2d 14h
submitted 16 May
SOCIAL
MLR-0816
SOCIAL · LINKEDIN · ENLinkedIn post · LINQ-NEXT HSA approval announcement
SGMarketing SGREVIEW
2d 22h
submitted 16 May
PDF
MLR-0815
CONFERENCE · POSTER · ENHRS Asia poster · 24-month outcomes data
APACDr. L. WeiREVIEW
3d 12h
submitted 15 May
VIDEO
MLR-0813
PATIENT VIDEO · 2-MIN · ZH-TCPatient education · "What is LINQ-NEXT?"
TWMarketing TPECHANGES
3d 18h
submitted 15 May
PDF
MLR-0812
SALES AID · PRINTED · KOKorean rep leave-behind · 4-page summary
KRMarketing SeoulREVIEW
4d 11h
submitted 14 May
WEB
MLR-0811
WEB · LANDING · ENAustralian HCP landing page · TGA approval announcement
AUMarketing SydneyREVIEW
5d 02h
submitted 13 May
WORKFLOWTHEMIS's review pipeline · always-onsubmission → THEMIS scan → Dev sign-off → MLR Chair approval → market
▶
Unlike sequential stages, MLR runs continuously for the commercial life of LINQ-NEXT. Each promotional asset moves through the same 4-step pipeline. Median time-to-approve: 2.3 hours. Hard blocks pause the asset entirely until claims are revised.
STEP 1 · INGEST
Asset submission
Marketing team uploads asset · THEMIS auto-classifies channel, market, language, claim-density.
~3 min
STEP 2 · CLAIM SCAN
THEMIS claim-by-claim
Every claim cross-checked against approved IFU for that market + Claim Library + locked CER.
~12 min / asset
STEP 3 · DEV SIGN-OFF
Human MLR review
Dev Krishnan reviews THEMIS's claim verdicts. Approves, requests changes, or escalates contested claims.
~45 min median
STEP 4 · MARKET
Approved · live
Asset added to approved-collateral library. Sales reps can pull. Claim Library grows. THEMIS learns.
2.3h median total
HARD-BLOCK PATH
If THEMIS detects off-label claim, asset is hard-blocked at Step 2. No human can override. Asset returns to marketing team with claim-by-claim verdict and required revisions. If off-label promotion to HCPs is detected post-distribution, automatic regulatory self-report within 5 business days (POL-REPORTABLE-EVENT-V2).
Case attributes
CaseMEDTRONIC-ICM-001
DeviceLINQ-NEXT · Class III ICM
MLR ChairD. Krishnan · primary reviewer
VP Quality oversightA. Reddy · escalation
Approved marketsHK · live · SG · AU · approved · live in 12d
Pending marketsJP · KR · TW (in Stage 05) · CN (Stage 04 post-CT)
Claim library186 approved · 14 in review · 7 retired
Stage started12 May 2026 · HK first approval
Stage sealsNEVER · runs through commercial life
Per-market promotional rules
JP · PMDAPre-clearance · efficacy claims require PMDA notification
KR · MFDSHCP-only restrictions · DTC ads prohibited for Class III
AU · TGATGA Advertising Code · superiority claims need head-to-head
SG · HSAHSA HPP code · honest-fair-balanced standard
TW · TFDAPre-review for HCP materials · Chinese translation required
HKUCMP code · public hospital advertising restrictions
Claim library · 186 approved claims · THEMIS reference
Every approved claim is fingerprinted, cited to source, and bound to applicable markets. THEMIS matches new asset claims against this library first; novel claims trigger full evidence review.
Detection sensitivity"95.3% AF detection sensitivity" · all markets · CER §3.1
Detection sens · KR"94.1% in non-stroke subgroup n=220" · approved KR only
Battery life"up to 4.5 years on single insertion" · all markets · battery file v4
Device class"smallest implantable cardiac monitor in market" · all · spec sheet v6
Population · AU"ambulatory adults with elevated AF risk" · AU only · TGA approved IFU
Population · JP"adults with cryptogenic stroke history" · JP only · PMDA narrowed
Insertion · all"in-office insertion in 5-10 minutes by trained cardiologist" · all markets
Removable"removable on patient request" · all markets · IFU §5.2
Trust + audit · stage 06 · 847 events (most recent)
a1f9...3c87THEMIS · MLR-0817 hard-blocked · 2 off-label claims17 May · 14:22
7d22...0e14THEMIS · MLR-0814 hard-blocked · superiority unsubstantiated15 May · 16:48
e391...7a22D. Krishnan · MLR-0816 approved · added 1 claim to library16 May · 17:32
b8c1...4d20THEMIS · MLR-0809 hard-blocked · stroke prevention claim13 May · 11:15
c19d...3b87HK launch collateral wave 1 · 14 assets approved12 May · 14:30
5b41...8e62Stage 06 instantiated · HK first approval received12 May · 14:15
Stage ThreadTHEMIS · BLOCK
06 MLR · 847 events · 3 hard blocks open
THEMIS → BLOCK17 May · 14:22
MLR-2026-0817 hard-blocked. Two off-label claims detected. Claim 1 ("detects 95% of all clinically significant arrhythmias including AF, AV block, and VT") implies efficacy outside the approved AF-only indication. Claim 2 ("prevents up to 38% of recurrent strokes") makes an outcomes claim with no LINQ-NEXT outcomes endpoint. Block is non-overridable. Asset must be revised. Conference is 03-05 Jun in Seoul — 12-day clock. Routing to Mei Lin.
a1f9...3c87 · BLOCKED
THEMIS17 May · 14:18
MLR-2026-0817 ingested. Korean cardiology conference booth video, 90 seconds, language: Korean. 8 claims detected. Cross-checking against approved KR IFU (PMDA narrowed: "adults with cryptogenic stroke history"), Claim Library (186 entries), locked CER v17.
THEMIS16 May · 17:32
MLR-2026-0816 approved by Dev Krishnan. LinkedIn post announcing HSA approval. All 4 claims matched existing library entries. Added 1 new claim variant ("approved in Singapore for ambulatory AF monitoring") to library, market-bound to SG.
D. ATLASN · MLR CHAIR15 May · 18:00
THEMIS — for the MLR-0814 superiority claim, can you check whether Reveal LINQ legacy materials use similar language? If they do and they're approved, we may have precedent.
THEMIS15 May · 18:04
Checked. Reveal LINQ materials use "next-generation" only when paired with explicit features (e.g. "next-generation battery technology — 4.5 yr life"). Standalone "next-generation" without a specified feature is not in the precedent set. MLR-0814 says "next-generation cardiac monitoring" with no feature anchor — reads as comparative superiority. Block stands. Could lift if marketing reworks to "with next-generation battery technology" or similar.
Coming soon

This surface ships in the next demo cut.

For the LINQ-NEXT walkthrough, the agent's reasoning trace and the sealed receipts are the proof — every action you've seen so far is governance-traceable.

Ask Ujjwal what you'd like to see next.

Handoff packet · THEMIS · 06 MLR Review → ATLAS · 07 Market Access
FROMTHEMIS · 06 MLR Review
TOATLAS · 07 Market Access
RECEIPTc41a…77b8
ASSETS REVIEWED208 promotional pieces · 90-day window
APPROVED164 · live in market
BLOCKED3 · cannot ship (off-label efficacy claims)
CHANGES REQUESTED11 · with claim-by-claim verdicts
IN REVIEW27 · THEMIS queue
APPROVED CLAIM LIBRARY106 substantiated assertions · indication-narrowed
INDICATION SCOPEAF detection · adults ≥18 · cryptogenic stroke history
COMMERCIAL CONSTRAINTSNo outcomes claims · no head-to-head urgency · no acuity superiority
ENFORCEMENTPOL-OFF-LABEL-BLOCK-V3 · POL-REPORTABLE-EVENT-V2