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.

Dexamethasone for Treatment of COVID-19

Dexamethasone is a glucocorticoid that is FDA-approved for numerous indications; it is under investigation for the treatment of COVID-19. Glucocorticoids are adrenocortical steroids that modify the body’s immune responses to diverse stimuli. Dexamethasone is indicated for treatment of allergic states, dermatologic diseases, endocrine disorders, gastrointestinal diseases, hema…

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InterAtrial Shunt Device for Heart Failure

The interatrial shunt device (IASD) is a transcatheter interatrial shunt for treatment of heart failure with preserved or borderline reduced ejection fraction. It is proposed to decrease elevated left atrial pressure in patients with heart failure and preserved or borderline reduced ejection fraction. The device is implanted within the septum separating the two atrial chamber…

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RBX2660 for Fecal Microbiota Transplantation

RBX2660 is a microbiota-based investigational product for fecal microbiota transplantation proposed to treat recurrent Clostridium difficile infection. It is derived from fresh stool from multiple donors; both donors and stool samples are methodically screened. Pooled stool samples are commercially prepared under good manufacturing processes. RB…

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Givlaari (Givosiran) for Acute Hepatic Porphyria

Givlaari is a subcutaneously administered ribonucleic acid interference (RNAi) agent that inhibits delta-aminolevulinate synthase 1 (ALAS1) synthesis, a key regulator of the heme biosynthetic pathway in the liver. Givlaari is believed to reduce ALAS1 levels, thereby decreasing delta-aminolevulinic acid (ALA) and porphobilinogen (PBG) levels. Decreasing ALA and PBG levels to n…

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