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.
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?
Edison System (HistoSonics) for Histotripsy of Renal Tumors
The Edison System (HistoSonics) is a nonthermal focused ultrasound system with real-time image guidance under investigation for the noninvasive mechanical destruction of stage I primary solid renal tumors via histotripsy.
Eplontersen (Wainua; Ionis Pharmaceuticals Inc./AstraZeneca) for Hereditary Transthyretin-mediated Amyloid Polyneuropathy
Eplontersen (Wainua; Ionis Pharmaceuticals Inc./AstraZeneca) is an injectable transthyretin-directed antisense oligonucleotide indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Filsuvez (Birch Triterpenes) Topical Gel (Chiesi Global Rare Diseases) for Epidermolysis Bullosa
Filsuvez (birch triterpenes) topical gel (formerly Oleogel-S10; Chiesi Global Rare Diseases) is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa in adult and pediatric patients 6 months of age and older.
Globe Pulsed Field Mapping and Ablation System (Kardium Inc.) for Atrial Fibrillation
The Globe Pulsed Field Mapping and Ablation System is an investigational pulsed-field ablation system for treatment of atrial fibrillation.
PulseSelect Pulsed Field Ablation (PFA) System (Medtronic Inc.) for Atrial Fibrillation
The PulseSelect system (Medtronic Inc.) is a pulsed field ablation (PFA) system indicated for cardiac electrophysiological mapping (stimulation and recording) and for treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation or persistent atrial fibrillation (episode duration less than 1 year).
Lovotibeglogene Autotemcel (Lyfgenia; Bluebird Bio) for Sickle Cell Disease
Lovotibeglogene autotemcel (Lyfgenia; Bluebird Bio Inc.) is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events.
Aortix Percutaneous Mechanical Circulatory Support Device (Procyrion Inc.)
Aortix is an investigational percutaneous mechanical circulatory support device in development for the treatment of chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure with worsening renal function.
Sonpiretigene Isteparvovec (Nanoscope Therapeutics Inc.) for Retinitis Pigmentosa
Sonpiretigene isteparvovec is an investigational gene therapy for retinitis pigmentosa, administered as an intravitreal injection.
Rebonuputemcel Injectable Discogenic Cell Therapy (IDCT; DiscGenics Inc.) for Degenerative Disc Disease
Rebonuputemcel Injectable Discogenic Cell Therapy (IDCT; DiscGenics Inc.) is an allogeneic progenitor cell therapy for the treatment of symptomatic early-to-moderate lumbar degenerative disc disease at a single level from L3 to S1.