The Barostim neo System is an implantable neuromodulation device designed to improve cardiac function by delivering electrical stimulation to baroreceptors in the wall of the carotid artery. The system is designed to take advantage of the body’s natural baroreflex system. Activation of baroreceptors in the wall of the carotid artery with baroreflex activation therapy stimulat…
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.
Rozlytrek (Entrectinib)
Rozlytrek (entrectinib) is an oral tumor-agnostic agent intended to selectively inhibit the tyrosine kinase activity of TRKA, TRKB, TRKC, and ROS1 (ROS proto-oncogene 1 receptor tyrosine kinase) rearrangements. Rozlytrek is indicated for the treatment of adult and adolescent patients whose cancers have NTRK (neurotrophic tyrosine receptor kinase) gene fusion, and for whom the…
Balversa (Erdafitinib) for Urothelial Carcinoma
Balversa is an oral kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma that has susceptible fibroblast growth factor receptor 3 (FGFR3) or FGFR2 genetic alterations and has progressed during or following at least 1 line of prior platinum-containin…
Rozlytrek (Entrectinib)
Rozlytrek (entrectinib) is an oral tumor-agnostic agent intended to selectively inhibit the tyrosine kinase activity of TRKA, TRKB, TRKC, and ROS1 (ROS proto-oncogene 1 receptor tyrosine kinase) rearrangements. Rozlytrek is indicated for the treatment of adult and adolescent patients whose cancers have NTRK (neurotrophic tyrosine receptor kinase) gene fusion, and for whom the…
Balversa (Erdafitinib) for Urothelial Carcinoma
Balversa is an oral kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma that has susceptible fibroblast growth factor receptor 3 (FGFR3) or FGFR2 genetic alterations and has progressed during or following at least 1 line of prior platinum-containin…
Sunosi (Solriamfetol)
Sunosi is an oral phenylalanine-derived selective dopamine and norepinephrine reuptake inhibitor (DNRI). Norepinephrine inhibits rapid eye movement sleep and promotes wakefulness. Dopamine plays a role in areas of the brain responsible for sleep regulation. Sunosi is indicated for the improvement in wakefulness in adult patients with excessive sleepiness associated with narco…
Sunosi (Solriamfetol)
Sunosi is an oral phenylalanine-derived selective dopamine and norepinephrine reuptake inhibitor (DNRI). Norepinephrine inhibits rapid eye movement sleep and promotes wakefulness. Dopamine plays a role in areas of the brain responsible for sleep regulation. Sunosi is indicated for the improvement in wakefulness in adult patients with excessive sleepiness associated with narco…
Turalio (Pexidartinib) for Tenosynovial Giant Cell Tumor
Turalio (pexidartinib) is an oral small molecule kinase inhibitor of colony stimulating factor-1 receptor (CSF1R) for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations, and which is not amenable to improvement with surgery.
Turalio (Pexidartinib) for Tenosynovial Giant Cell Tumor
Turalio (pexidartinib) is an oral small molecule kinase inhibitor of colony stimulating factor-1 receptor (CSF1R) for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations, and which is not amenable to improvement with surgery.
Nubeqa (Darolutamide) for Nonmestastatic CRPC
Nubeqa is a nonsteroidal second-generation androgen receptor inhibitor that competes with androgen by binding to the androgen receptor. It reduces the ability of androgen to promote the growth of prostate cancer cells. Nubeqa is indicated for the treatment of patients with nonmetastatic castration-resistant prostate cancer.