Amvuttra (vutrisiran) is an injectable RNA interference (RNAi) therapeutic agent indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
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.
Lecanemab (Leqembi) is an intravenously administered anti-amyloid beta (Aβ) protofibril antibody indicated for the treatment of Alzheimer disease.
The LimiFlex Dynamic Sagittal Tether is a minimally invasive spinal implant designed to stabilize the spine, without fusing it, and maintain motion after spinal decompression in patients with grade 1 lumbar degenerative spondylolisthesis with spinal stenosis.
Eladocagene exuparvovec is an investigational gene replacement therapy administered by bilateral intraputaminal infusion for the treatment of aromatic L-amino acid decarboxylase deficiency.
Avasopasem manganese is an investigational intravenously administered superoxide dismutase mimetic intended to reduce the incidence and severity of radiation-induced oral mucositis in patients undergoing radiotherapy for head and neck cancer.
Omecamtiv mecarbil is a first-in-class oral cardiac myosin activator under investigation for the treatment of heart failure with reduced ejection fraction (HFrEF).
TissueGene-C is an allogeneic cell and gene therapy delivered via intra-articular injection in development for the treatment of knee osteoarthritis.
Remestemcel-L is an investigational allogeneic liquid cell suspension of ex-vivo cultured adult human mesenchymal stem cells derived from healthy donor bone marrow proposed for the treatment of pediatric patients with acute graft-versus-host-disease (aGVHD) refractory to standard first-line steroid therapy.
The Detour System is an endovascular device for catheter-based femoropopliteal bypass for the treatment of long occlusions of the superficial femoral artery in patients with moderate to severe peripheral artery disease.
The Medtronic Extravascular Implantable Cardioverter Defibrillator is an implantable cardioverter-defibrillator (ICD) with a substernal lead and subcutaneously implanted generator proposed to treat patients with a class I or IIa indication for an ICD for primary or secondary prevention of sudden cardiac arrest and sudden cardiac death.