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.

Melphalan Hepatic Delivery System (Hepzato Kit) for Liver-Dominant Metastatic Ocular Melanoma

The Melphalan Hepatic Delivery System (M-HDS; proposed U.S. name, Hepzato Kit) is a catheter-based drug delivery and chemofiltration kit for intra-arterial administration of melphalan chemotherapy directly to the liver followed by extracorporeal filtration of hepatic venous blood to reduce melphalan concentration before returning blood to systemic circulation. It is used to p…

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Humacyl Acellular Vessel for Vascular Trauma

Humacyl is an off-the-shelf bioengineered human acellular vessel proposed for use in the repair of vascular trauma. This technology uses a process to decellularize donated human vascular smooth muscle cells, while preserving extracellular matrix proteins. This results in a tubular scaffold that is acellular at the time of implantation and becomes populated with the patient’s …

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