Emerging Technology Reports

The Emerging Technology Report provides regular updates about emerging and potentially disruptive technologies that are likely to have a significant impact in healthcare. This “early warning” report monitors new health technologies from 6 months to 2 years within a regulatory submission and tracks those as they go through clinical trial development and the regulatory approval process.

For each emerging technology, our analysts describe the technology and intended use, its prospects relative to the regulatory process and FDA information, competing technologies, relevant clinical guidelines, high-level look at the evidence such as published abstracts in the medical literature and available meeting abstracts, and available clinical trials.

Eko Low Ejection Fraction Tool (ELEFT; Eko Health Inc.) for Artificial Intelligence (AI)-based Stethoscope Detection of Low Ejection Fraction

The Eko Low Ejection Fraction Tool (ELEFT; Eko Health Inc.) is an artificial intelligence (AI)-based algorithm that analyzes single-lead electrocardiogram (ECG) data collected via a compatible Eko digital stethoscope as an aid in the detection of low left ventricular ejection fraction in adult patients during a routine physical examination. It is not intended as a sole means …

Remestemcel-L (Mesoblast Ltd.) for Acute Graft-Versus-Host Disease

Remestemcel-L is an investigational allogeneic liquid cell suspension of ex-vivo cultured adult human mesenchymal stem cells derived from healthy donor bone marrow proposed for the treatment of pediatric patients with acute graft-versus-host-disease (aGVHD) refractory to standard first-line steroid therapy.

Lifileucel (Amtagvi; Iovance Biotherapeutics Inc.) for Advanced Melanoma

Lifileucel (Amtagvi; Iovance Biotherapeutics Inc.) is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.