Nirsevimab-alip (Beyfortus; AstraZeneca) is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
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?
AccuCinch Ventricular Restoration System (Ancora Heart Inc.) for Heart Failure
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).
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…
Phoenix Transcutaneous Auricular Vagus Nerve Stimulation System (Evren Technologies Inc.) for Posttraumatic Stress Disorder
The Phoenix (Evren Technologies Inc.) is a transcutaneous auricular vagus nerve stimulation system and symptom-tracking mobile application under investigation for at-home treatment of posttraumatic stress disorder.
Lenadogene Nolparvovec (GenSight Biologics) for Leber Hereditary Optic Neuropathy
Lenadogene nolparvovec is an investigational intravitreal adeno-associated virus vector-based gene therapy for the treatment of leber hereditary optic neuropathy.
Artificial Intelligence-Based Electrocardiography (AI-ECG) Algorithm (Anumana Inc.) for Detection of Low Left Ventricular Ejection Fraction (LVEF)
The Artificial Intelligence-Based Electrocardiography (AI-ECG) Algorithm (Anumana Inc.) analyzes 12-lead ECG data to detect low left ventricular ejection fraction (LVEF), and is proposed for detection of asymptomatic left ventricular systolic dysfunction in adult patients.
Artificial Intelligence-Based Electrocardiography (AI-ECG) Algorithm (Anumana Inc.) for Detection of Cardiac Amyloidosis
The Artificial Intelligence Electrocardiography (AI-ECG) Algorithm (Anumana Inc.) analyzes 12-lead ECG data to aid in the early detection of cardiac amyloidosis in adult patients.
Lecanemab (Leqembi; Esai Co. Ltd. and Biogen) for Alzheimer Disease
Lecanemab (Leqembi; Esai Co. Ltd. and Biogen) is an intravenously administered anti-amyloid beta (Aβ) protofibril antibody indicated for the treatment of Alzheimer disease.
Valoctocogene Roxaparvovec (Roctavian; BioMarin Pharmaceutical) for Hemophilia A
Valoctocogene roxaparvovec (Roctavian; Biomarin Pharmaceutical Inc.) is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity < 1 international unit/deciliter [IU/dL]) without pre-existing antibodies to adeno-associated virus serotype 5 detected by a U.S. ...
Sepiapterin (PTC Therapeutics) for Phenylketonuria
Sepiapterin is an investigational oral synthetic precursor to tetrahydrobiopterin in development for treatment of phenylketonuria.