Avasopasem manganese (Galera Therapeutics Inc.) is an investigational intravenous superoxide dismutase mimetic intended to reduce the incidence and severity of radiation-induced oral mucositis in patients undergoing radiotherapy for head and neck cancer.
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.
Nirsevimab-alip (Beyfortus; AstraZeneca and Sanofi) to Prevent Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus
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.
Bulevirtide (Gilead Sciences Inc.) for Chronic Hepatitis Delta Virus
Bulevirtide (Gilead Sciences Inc.) is an investigational, first-in-class, subcutaneously injected virion entry inhibitor proposed for the treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease.
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).
Nelli System (Neuro Event Labs) for Seizure Detection
The Nelli System (Neuro Event Labs) is an investigational video- and audio-based seizure detection system may be used in a healthcare facility or in a patient’s home.
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.