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.

AGENT Drug-Coated Balloon (Boston Scientific Corp.) for Coronary In-stent Restenosis

The AGENT Drug-Coated Balloon (Boston Scientific Corp.) is a paclitaxel-coated balloon catheter indicated for treatment of coronary in-stent restenosis (ISR). It is intended to be used after appropriate vessel preparation in adult patients undergoing percutaneous coronary intervention (PCI) in coronary arteries 2.0 millimeters (mm) to 4.0 mm in diameter and lesions up to 26 m…

Fidanacogene Elaparvovec-dzkt (Beqvez; Pfizer Inc.) for Hemophilia B

Fidanacogene elaparvovec-dzkt (Beqvez; Pfizer Inc.) is a single-infusion gene therapy for the treatment of adults with moderate to severe hemophilia B who currently use factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated vi…