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.

Hepzato Kit (Melphalan/Hepatic Delivery System; Delcath Systems Inc.) Liver-Directed Therapy for Metastatic Uveal Melanoma

The Melphalan/Hepatic Delivery System (Hepzato Kit; Delcath Systems Inc.) is a melphalan drug pack and catheter-based chemofiltration delivery kit indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymp…

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…