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.

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…

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Omaveloxolone for Friedreich Ataxia

Omaveloxolone is an investigational oral drug that activates nuclear factor erythroid 2–related factor 2 (Nrf2). It is proposed for the treatment of Friedreich ataxia (FA), a rare, hereditary, neurodegenerative disorder that is driven by mitochondrial dysfunction and impaired Nrf2 activity. FA typically presents between the ages of 10 and 15 years.

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Eko Artificial Intelligence-based Electrocardiography Algorithm for Detection of Low Ejection Fraction

The Eko artificial intelligence (AI)-based electrocardiography (ECG) low ejection fraction tool (ELEFT) algorithm is used with the Eko Duo + ECG Digital Stethoscope to analyze single-lead ECG data to detect low left ventricular ejection fraction (LVEF), and is proposed for point-of-care screening of adult patients in the primary care/outpatient setting.

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Anumana Artificial Intelligence (AI)-based Electrocardiography (ECG) Algorithm for Detection of Low Left Ventricular Ejection Fraction (LVEF)

The Anumana artificial intelligence (AI)-based electrocardiography (ECG) algorithm analyzes 12-lead ECG data to detect low left ventricular ejection fraction (LVEF), and is proposed for detection of asymptomatic left ventricular systolic dysfunction (ALVSD) in adult patients in the primary care/outpatient setting.

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