Betibeglogene autotemcel (beti-cel; Zynteglo; formerly Lentiviral Autologous Beta-Globin Gene Therapy, LentiGlobin) is an autologous hematopoietic stem cell-based gene therapy for the treatment of adult and pediatric patients with β-thalassemia who require regular red blood cell (RBC) transfusions.
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?
SER-109 is an investigational oral microbiota-based product for fecal microbiota transplantation (FMT) proposed to prevent recurrent Clostridioides (formerly Clostridium) difficile infection (CDI) in adults with a history of 3 or more CDI episodes within a 12-month period.
The dNerva Lung Denervation System is an investigational, bronchoscopic catheter-based pulmonary nerve ablation procedure proposed to reduce the frequency and severity of chronic obstructive pulmonary disease (COPD) exacerbations.
Lecanemab (BAN2401) is an investigational, intravenously administered anti-amyloid beta (Aβ) protofibril antibody proposed for the treatment of early Alzheimer disease.
The iStent infinite is a trabecular micro-bypass stent system intended to reduce intraocular pressure (IOP) as a stand-alone procedure for uncontrolled primary open-angle glaucoma (OAG). The device includes 3 heparin-coated titanium stents measuring one-third millimeter (mm) in length and width. The stents are preloaded into an auto-injection system that allows the surgeon to…
The pro2cool device is a portable head and neck cooling device under investigation for the treatment of adolescent mild traumatic brain injury (mTBI; concussion).
Teplizumab is an intravenously administered anti-CD3 monoclonal antibody in development for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.
Omaveloxolone is an investigational oral drug that activates nuclear factor erythroid 2–related factor 2 (Nrf2). It is proposed for the treatment of Friedreich ataxia (FA), a rare, hereditary, neurodegenerative disorder that is driven by mitochondrial dysfunction and impaired Nrf2 activity. FA typically presents between the ages of 10 and 15 years.
Eko Artificial Intelligence-based Electrocardiography Algorithm for Detection of Low Ejection Fraction
The Eko artificial intelligence (AI)-based electrocardiography (ECG) low ejection fraction tool (ELEFT) algorithm is used with the Eko Duo + ECG Digital Stethoscope to analyze single-lead ECG data to detect low left ventricular ejection fraction (LVEF), and is proposed for point-of-care screening of adult patients in the primary care/outpatient setting.
Anumana Artificial Intelligence (AI)-based Electrocardiography (ECG) Algorithm for Detection of Low Left Ventricular Ejection Fraction (LVEF)
The Anumana artificial intelligence (AI)-based electrocardiography (ECG) algorithm analyzes 12-lead ECG data to detect low left ventricular ejection fraction (LVEF), and is proposed for detection of asymptomatic left ventricular systolic dysfunction (ALVSD) in adult patients in the primary care/outpatient setting.