The Portable Neuromodulation Stimulator (PoNS) device is a portable neuromodulation stimulator for short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis for use by prescription only as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and older.
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.
Finerenone is an investigational nonsteroidal, selective mineralocorticoid receptor antagonist for treatment of patients with chronic kidney disease and type 2 diabetes.
Abecma (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after 4 or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Anifrolumab is an investigational fully human monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor, blocking the activity of all type I IFNs. It is proposed for the treatment of adults with moderately to severely active systemic lupus erythematosus (SLE) who are receiving standard care.
Ryplazim is an investigational intravenous plasminogen replacement therapy for treatment of congenital plasminogen deficiency in children and adults. Ryplazim is recovered from healthy donor plasma; plasminogen is extracted using a proprietary process. Purified isolated plasminogen is administered by intravenous infusion.
Mavacamten is an investigational oral myosin inhibitor that targets the underlying molecular mechanisms of hypertrophic cardiomyopathy (HCM). It is proposed for the treatment of patients with symptomatic obstructive HCM.
Evrysdi (risdiplam; formerly RG7916) is an oral small molecule splicing modifier of the survival motor neuron 2 (SMN2) gene indicated for the treatment of spinal muscular atrophy (SMA) in patients 2 months of age and older.
Retifanlimab is an investigational intravenous humanized monoclonal antibody that inhibits the activity of programmed death-1 (PD-1). By blocking PD-1, retifanlimab acts as an immune checkpoint inhibitor, freeing T cells to kill cancer cells and boosting immune system response against certain cancers. Retifanlimab is proposed as a monotherapy for locally advanced and metastat…
Amondys 45 (casimersen) is an intravenously administered antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping.
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.