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).
Horizon ScanningIt is a challenge for health plans and clinicians to know what emerging technologies are in the preapproval phase and what their clinical, financial, and risk impacts might be. This is where we come in.
The Hayes Horizon Scanning Solution identifies innovative and potentially disruptive health technologies that are in various stages of the regulatory approval process. Our Research Analysts continually investigate new technologies that are on the horizon or in the early stages of clinical investigation, as well as the testing of existing technologies that may be seeking approval for new clinical applications. Hayes Horizon Scanning helps you track emerging technologies before you need to make decisions. Accessed through the Hayes Knowledge Center, Hayes Horizon Scanning addresses the following fundamental questions to help our clients forecast emerging technologies:
- Is this emerging technology new or replacing an existing technology?
- Where is this technology in the FDA regulatory process?
- When will this technology be commercially available in the market?
- What is the projected use, cost, and financial impact of this technology?
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 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 is an investigational self-administered calcium-channel blocker nasal spray for rapid termination of paroxysmal supraventricular tachycardia outside of the healthcare setting.
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.) is an investigational, intravenously administered amyloid beta-directed antibody proposed for the treatment of Alzheimer 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 Inc.) is an investigational gene therapy delivered by autologous hematopoietic stem cell transplantation for the treatment of sickle cell disease.
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…
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.