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.
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…
Atidarsagene autotemcel is an investigational gene therapy administered by intravenous infusion for the treatment of metachromatic leukodystrophy.
The Pulnovo Pulmonary Artery Denervation (PADN) catheter is an investigational pulmonary artery catheter intended for radiofrequency ablation of pulmonary nerves to treat pulmonary arterial hypertension (PAH) in adults.
The Therapeutic Intravascular Ultrasound System (TIVUS) is an intravascular ultrasound system under investigation for catheter-based pulmonary artery denervation to treat adult patients with pulmonary arterial hypertension.
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 …
The WiSE CRT system is a wireless left ventricular pacing system that works with an implanted right ventricular pacemaker and/or defibrillator for patients in whom cardiac resynchronization therapy (CRT) is indicated.
Tofersen is an investigational antisense oligonucleotide proposed for the treatment of amyotrophic lateral sclerosis (ALS) caused by mutations in the SOD1 gene.
Tofersen is an investigational antisense oligonucleotide proposed for the treatment of amyotrophic lateral sclerosis (ALS) caused by mutations in the SOD1 gene.
Botaretigene sparoparvovec is an investigational gene replacement therapy for the treatment of X-linked retinitis pigmentosa due to mutations in the RPGR gene. It is administered by subretinal injection.
Donanemab is an investigational, intravenously administered amyloid beta-directed antibody proposed for the treatment of Alzheimer disease.