Tissue-embedded sensors

Grader A: partial

New implanted biosensors reached routine but niche use: Eversense implantable CGM (FDA June 2018), CardioMEMS PA-pressure sensor (FDA 2014); both a small share of their populations. Implantable loop recorders are routine but predate the poster and record electrical rhythm rather than tissue biochemistry. Partial.

Test: D37 health: share of relevant patients, providers or procedures using it by 2022 (hit >=5%; partial <5% real use by 2022 or 5% in 2023-2025; miss no real use by 2025); relevant: patients with diabetes or heart disease

• PMA P160048 Eversense Continuous Glucose Monitoring System (2018-06-21): First implanted CGM approved
• Implantable loop recorder (2025): Subcutaneous cardiac monitors in routine use for syncope and AF detection

Grader B: partial

Fully implanted monitoring sensors are in routine but niche use: Eversense implantable CGM (FDA June 2018), CardioMEMS pulmonary-artery sensor (2014) and insertable cardiac loop recorders. Each serves a small slice of its population; most CGM users wear transcutaneous (not implanted) sensors. No evidence of 5% share by 2022.

Test: D37 health: >=5% of relevant patients (e.g. CGM users, heart-failure or arrhythmia monitoring) use implanted sensors by 2022 = hit; real use below 5% = partial; none by 2025 = miss.

• FDA approves first continuous glucose monitoring system with a fully implantable glucose sensor (2018-06-21): First fully implantable CGM sensor approved (Eversense, 90 days, subcutaneous).