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.
Emerging Technology Reports
The Emerging Technology Report provides regular updates about emerging and potentially disruptive technologies that are likely to have a significant impact in healthcare. This “early warning” report monitors new health technologies from 6 months to 2 years within a regulatory submission and tracks those as they go through clinical trial development and the regulatory approval process.
For each emerging technology, our analysts describe the technology and intended use, its prospects relative to the regulatory process and FDA information, competing technologies, relevant clinical guidelines, high-level look at the evidence such as published abstracts in the medical literature and available meeting abstracts, and available clinical trials.
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.