Epidermal sensors

Grader A: partial

Epidermal-electronics spinouts reached clinical products: Sibel's ANNE soft wireless sensors got FDA clearances (latest 2023) and were evaluated in NICUs; use is pilots and early adoption, far below 5% of monitored patients. A broad reading that counts adhesive ECG patches (Zio) could give a hit, but those are not the thin epidermal electronics the label names.

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: monitored patients (e.g. NICU, inpatients)

• Sibel Health announces a new FDA clearance for advanced wireless monitoring in neonates and infants (2023-05-10): ANNE One soft skin sensors cleared for neonates to adults
• Evaluation of Sibel's Advanced Neonatal Epidermal (ANNE) wireless continuous physiological monitor in Nairobi, Kenya (2022): Clinical evaluation in 84 neonates, 2019-2020

Grader B: partial

The Rogers-lab line reached clinic: Sibel Health's ANNE skin sensors gained FDA 510(k) clearances (ANNE One, May 2023, for neonates to adults; ANNE Maternal) and are deployed in some hospitals and low-income-country NICUs. Use is real but limited to pilots and early deployments, well under 5% of monitored patients. Conventional adhesive ECG patches are not the thin epidermal electronics the label names.

Test: D37 health: >=5% of relevant monitored patients (e.g. NICU, inpatients) use epidermal sensors by 2022 = hit; real clinical use below 5% = partial; none by 2025 = miss.

• ANNE One wireless monitoring platform receives FDA clearance (AASM) (2023-05): FDA 510(k) for Sibel's ANNE One skin-mounted wireless sensors, neonates to adults.
• Evaluation of Sibel's Advanced Neonatal Epidermal (ANNE) wireless continuous physiological monitor in Nairobi, Kenya (2022): Epidermal sensors at evaluation/pilot stage in neonatal care.