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.

Betibeglogene Autotemcel (Zynteglo) for Beta Thalassemia

Betibeglogene autotemcel (beti-cel; Zynteglo; formerly Lentiviral Autologous Beta-Globin Gene Therapy, LentiGlobin) is an autologous hematopoietic stem cell-based gene therapy for the treatment of adult and pediatric patients with β-thalassemia who require regular red blood cell (RBC) transfusions.

iStent infinite Trabecular Micro-Bypass System for Open-Angle Glaucoma

The iStent infinite is a trabecular micro-bypass stent system intended to reduce intraocular pressure (IOP) as a stand-alone procedure for uncontrolled primary open-angle glaucoma (OAG). The device includes 3 heparin-coated titanium stents measuring one-third millimeter (mm) in length and width. The stents are preloaded into an auto-injection system that allows the surgeon to…

Pegzilarginase for Arginase 1 Deficiency

Pegzilarginase is an investigational recombinant form of the human enzyme arginase 1 (ARG1) proposed for the treatment of pediatric and adult patients with ARG1 deficiency. It is administered by intravenous infusion or subcutaneous injection.

GammaSense Stimulation System for Alzheimer Disease

The GammaSense Stimulation System is an investigational, home-use, wearable device that delivers auditory and visual stimulation to entrain gamma frequency neural activity in the brain. It is proposed for the treatment of mild to moderate Alzheimer disease (AD). Brainwave entrainment is a technique to prompt the brain’s neural activity to synchronize to the frequency of exter…

Organ Care System (OCS) Heart

The OCS Heart is a portable extracorporeal heart perfusion and monitoring system indicated for the preservation of donation-after-brain-death (DBD) donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation (e.g., > 4 hours of cross-clamp time); and for the ex vivo reanimation,…