The AccuCinch Ventricular Restoration System (Ancora Heart Inc.) is a transcatheter left ventricular cinching device proposed for treatment of symptomatic heart failure with reduced ejection fraction (HFrEF).
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.
Humacyl Acellular Vessel (Humacute Inc.) for Vascular Trauma
Humacyl (Humacyte Inc.) 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 wit…
Remestemcel-L (Mesoblast Ltd.) for Acute Graft-Versus-Host Disease
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.
Etripamil (Milestone Pharmaceuticals) for Paroxysmal Supraventricular Tachycardia
Etripamil is an investigational self-administered calcium-channel blocker nasal spray for rapid termination of paroxysmal supraventricular tachycardia outside of the healthcare setting.
Nelli System (Neuro Event Labs) for Seizure Detection
The Nelli System (Neuro Event Labs) is an investigational video- and audio-based seizure detection system may be used in a healthcare facility or in a patient’s home.
Donanemab (Eli Lilly and Co.) for Alzheimer Disease
Donanemab (Eli Lilly and Co.) is an investigational, intravenously administered amyloid beta-directed antibody proposed for the treatment of Alzheimer disease.
Exagamglogene Autotemcel (Vertex/CRISPR) for Sickle Cell Disease
Exagamglogene autotemcel (Vertex Pharmaceuticals and CRISPR Therapeutics) is an investigational gene therapy delivered by autologous hematopoietic stem cell transplantation for the treatment of sickle cell disease.
Lovotibeglogene Autotemcel (Bluebird Bio) for Sickle Cell Disease
Lovotibeglogene autotemcel (Bluebird Bio Inc.) is an investigational gene therapy delivered by autologous hematopoietic stem cell transplantation for the treatment of sickle cell disease.
AspyreRx (Better Therapeutics Inc.) Prescription Digital Behavioral Therapeutic for Type 2 Diabetes
AspyreRx (Better Therapeutics Inc.) is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes (T2D). The device targets behavior to aid in the management of T2D in patients who are under the care of a healthcare provider. AspyreRx provides cognitive behavioral therapy as a treatment th…
Automated Low-Flow Ascites Pump (alfapump; Sequana Medical NV) for Refractory Ascites
The automated low-flow ascites pump (alfapump; Sequana Medical NV) is an implantable wireless battery-powered pump for treatment of recurrent or refractory ascites due to liver cirrhosis.