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.
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.
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.
Fidanacogene elaparvovec is an investigational single-infusion gene therapy proposed for the treatment of hemophilia B.
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 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. ...
Exagamglogene autotemcel is an investigational gene therapy delivered by autologous hematopoietic stem cell transplantation for the treatment of transfusion-dependent beta thalassemia.
TAK-755 (Takeda Pharmaceutical Co. Ltd.) is an investigational, intravenous recombinant ADAMTS13 enzyme replacement therapy proposed for treatment of congenital thrombotic thrombocytopenic purpura.
Sepiapterin is an investigational oral synthetic precursor to tetrahydrobiopterin in development for treatment of phenylketonuria.