The WiSE CRT system is a wireless left ventricular pacing system that works with an implanted right ventricular pacemaker and/or defibrillator for patients in whom cardiac resynchronization therapy (CRT) is indicated.
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.
Genicular Artery Embolization With Embozene Microspheres (Varian, a Siemens Healthineers Company) for Symptomatic Knee Osteoarthritis
Embozene Microspheres (Varian, a Siemens Healthineers company) are biocompatible, nonresorbable, hydrogel particles under investigation for genicular artery embolization (GAE) to treat symptomatic knee osteoarthritis (KOA).
Edison System (HistoSonics) for Histotripsy of Liver Tumors
The Edison System (Histosonics Inc.) is a nonthermal focused ultrasound system with real-time image guidance intended for the noninvasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy.
Respiratory Syncytial Virus Vaccine (Abrysvo; Pfizer Inc.) for Prevention of Respiratory Syncytial Virus Disease in Infants Through Maternal Immunization
Abrysvo (respiratory syncytial virus vaccine; Pfizer Inc.) is a vaccine indicated for active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age.
Spring Distraction System (Cresco Spine) for Early Onset Scoliosis
The Spring Distraction System (Cresco Spine) is an investigational, growth-friendly implant in development for the treatment of early onset scoliosis (EOS). It is designed to provide continuous distraction and avoid the need for repeated lengthening procedures as the patient grows.
Palovarotene (Sohonos; Ipsen Biopharmaceuticals Inc.) for Fibrodysplasia Ossificans Progressiva
Palovarotene (Sohonos; Ipsen Biopharmaceuticals Inc.) is an oral retinoid indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for female persons and 10 years and older for male persons with fibrodysplasia ossificans progressiva.
Hepzato Kit (Melphalan/Hepatic Delivery System; Delcath Systems Inc.) Liver-Directed Therapy for Metastatic Uveal Melanoma
The Melphalan/Hepatic Delivery System (Hepzato Kit; Delcath Systems Inc.) is a melphalan drug pack and catheter-based chemofiltration delivery kit indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymp…
Avasopasem Manganese (Galera Therapeutics Inc.) for Radiotherapy-induced Oral Mucositis
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.
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.