The Vibrant vibrating capsule is an investigational device designed to alleviate symptoms of chronic idiopathic constipation (CIC) by inducing a bowel movement through mechanical vibration of the colon.
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?
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.
AMX0035 is an investigational co-formulation of sodium phenylbutyrate (PB) and taurursodiol (TURSO). PB is a prescription drug use to treat urea cycle disorders and TURSO (also known as tauroursodeoxycholic acid [TUDCA]) is a widely available non-prescription supplement. AMX0035 is proposed for the treatment of amyotrophic lateral sclerosis (ALS).
Elivaldogene autotemcel (eli-cel) is a lentiviral-based gene therapy for treatment of childhood cerebral adrenoleukodystrophy (CALD).
Betibeglogene autotemcel (beti-cel; brand name Zynteglo outside U.S.; formerly Lentiviral Autologous Beta-Globin Gene Therapy, LentiGlobin) aims to reduce or eliminate the need for regular blood transfusions in patients with transfusion-dependent beta thalassemia by replacing the faulty HBB gene in the patient’s DNA with a healthier copy of the …
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.
Pegzilarginase is an investigational recombinant form of the human enzyme arginase 1 (ARG1) proposed for the treatment of pediatric and adult patients with ARG1 deficiency. It is administered by intravenous infusion or subcutaneous injection.