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.
Horizon Scanning
It 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?
TriClip G4 System (Abbott Medical) Transcatheter Tricuspid Valve Repair for Tricuspid Regurgitation
The TriClip G4 System (Abbott Medical) is a transcatheter tricuspid valve repair system indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom transcatheter edge-to-edge valve repair is clinically appropriate and i…
Tabelecleucel (Pierre Fabre Laboratories and Atara Biotherapeutics) for Epstein-Barr Virus-Positive Posttransplant Lymphoproliferative Disease
Tabelecleucel (Pierre Fabre Laboratories and Atara Biotherapeutics Inc.) is an investigational allogenic T cell immunotherapy proposed for treatment of relapsed or refractory Ebstein-Barr virus-positive posttransplant lymphoproliferative disease.
Spinal Cord Neuromodulator (SCONE) Device (SpineX Inc.) for Neurogenic Bladder
The Spinal Cord Neuromodulator (SCONE; SpineX Inc.) is an investigational device that delivers transcutaneous electrical stimulation. It is proposed for improving urinary incontinence symptoms in adults with neurogenic bladder due to spinal cord injury, multiple sclerosis, or stroke.
Valeda Light Delivery System (LumiThera Inc.) for Dry Age-Related Macular Degeneration
The Valeda Light Delivery System (formerly LT-300; LumiThera Inc.) is a photobiomodulation device that delivers yellow, red, and near-infrared light to the eyes for treatment of dry age-related macular degeneration.
Transpose RT System for Rotator Cuff Tendinopathy
The Transpose RT system (formerly known as Transpose Ultra) is a device for enzymatic isolation and preparation of uncultured unmodified autologous adipose-derived regenerative cells (UA-ADRCs) for injection therapy. This therapy is proposed for stand-alone point-of-care treatment of partial-thickness rotator cuff tears.
Exagamglogene Autotemcel (Casgevy; Vertex/CRISPR) for Sickle Cell Disease
Exagamglogene autotemcel (Casgevy; Vertex Pharmaceuticals and CRISPR Therapeutics) is an autologous, genome-edited, hematopoietic stem cell-based gene therapy indicated for the treatment of sickle cell disease (SCD) in patients aged 12 years and older with recurrent vaso-occlusive crises (VOCs).
Hepzato Kit (Melphalan/Hepatic Delivery System; Delcath Systems Inc.) Liver-Directed Therapy for Metastatic Uveal Melanoma
The Melphalan/Hepatic Delivery System (Hepzato Kit; Delcath Systems Inc.) is a melphalan drug pack and catheter-based chemofiltration delivery kit indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymp…
V940 Individualized Neoantigen Therapy (Merck and Moderna) for Melanoma
V940 is an investigational messenger ribonucleic acid (mRNA)-based individualized melanoma vaccine.
ADAMTS13, Recombinant-krhn (Adzynma; Takeda Pharmaceutical Co. Ltd.) for Congenital Thrombotic Thrombocytopenic Purpura
ADAMTS13, recombinant-krhn (Adzynma; formerly TAK-755, BAX930, SHP655) (Takeda Pharmaceutical Co. Ltd.) is an intravenous human recombinant A disintegrin and metalloproteinase with thrombospondin motifs 13 (rADAMTS13) indicated for prophylactic or on demand enzyme replacement therapy in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura.