Viaskin Peanut is an investigational daily immunotherapy patch for treatment of peanut allergy in children aged 1 to 3 years.
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.
Alleviant (ALV1) System (Alleviant Medical Inc.) for Heart Failure
The Alleviant (ALV1) System is a radiofrequency catheter used to create an implant-free interatrial shunt for the treatment of heart failure with preserved ejection fraction (HFpEF) or heart failure with mildly reduced ejection fraction (HFmrEF).
Beremagene Geperpavec-svdt (Vyjuvek; Krystal Biotech Inc.) for Dystrophic Epidermolysis Bullosa
Vyjuvek is a topical gene therapy indicated for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
RSVpreF for Prevention of Lower Respiratory Tract Disease due to Respiratory Syncytial Virus in Older Adults
RSVPreF is an investigational recombinant RSV antigen vaccine for adults ≥ 60 years of age.
Revivent TC Transcatheter Ventricular Enhancement System (BioVentrix Inc.)
The Revivent TC Transcatheter Ventricular Enhancement System is a micro-anchor and tether system intended for minimally invasive left ventricular (LV) restoration in patients with LV scar/aneurysm and heart failure.
Reducer Coronary Sinus Implant (Shockwave Medical Inc.) for Refractory Angina
The Reducer (Shockwave Medical Inc.) is a catheter-delivered, hourglass-shaped, stainless steel mesh device implanted into the coronary sinus to improve blood flow to ischemic myocardial tissue in patients with refractory angina pectoris who are unsuitable for revascularization by coronary artery bypass grafting or percutaneous coronary intervention.
Varipulse Pulsed Field Ablation Catheter (Biosense Webster Inc.) for Atrial Fibrillation
Varipulse is an investigational pulsed-field ablation catheter for treatment of paroxysmal atrial fibrillation.
VE303 (Vedanta Biosciences Inc.) for Prevention of Recurrent Clostridioides Difficile Infection
VE303 is an investigational oral microbiome restoration therapy proposed to prevent recurrent Clostridioides difficile infection (CDI) in adults following antibacterial treatment for CDI.
Fezolinetant (Veozah; Astellas Pharma) for Vasomotor Symptoms Due to Menopause
Veozah is an NK3 receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
Globe Pulsed Field Mapping and Ablation System (Kardium Inc.) for Atrial Fibrillation
The Globe Pulsed Field Mapping and Ablation System is an investigational pulsed-field ablation system for treatment of atrial fibrillation.