An interferon/ribavirin-free direct-acting antiviral regimen chronic hepatitis C virus genotype 1 or 3 infection.
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.
Enroute Transcarotid Neuroprotection System (NPS)
The Enroute NPS (formerly the MICHI Neuroprotection System) protects the brain from plaque and debris dislodged during carotid artery angioplasty and stenting (CAS) by reversing blood flow and capturing the material in its in-line filter. It is the first and only embolic protection device for CAS designed for neck rather than groin access. The Enroute NPS device was introduced to the U.S. mark…
ReShape Integrated Dual Balloon System
The ReShape Dual Balloon is an endoscopically placed, temporary dual intragastric balloon. It is intended as an adjunct to diet and exercise in the treatment of obesity.
aura6000 Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy System
An implantable hypoglossal neurostimulator system for treatment of moderate to severe obstructive sleep apnea (OSA) in individuals who have failed or do not tolerate continuous positive airway pressure therapy or alternative OSA treatments.
Uptravi (Selexipag)
Selexipag is a first-in-class oral, nonprostanoid selective IP receptor agonist for treatment of pulmonary arterial hypertension.
Evera MRI SureScan ICD System
The Evera MRI SureScan system is an implantable cardioverter-defibrillator system designed to enable implanted patients to undergo full-body magnetic resonance imaging examinations under prescribed conditions.
Wearable Artificial Kidney
A wearable miniaturized dialysis system proposed for treatment of patients with end-stage renal disease.
Keytruda (Pembrolizumab) for First-Line Treatment of Advanced Melanoma
An intravenous programmed death-1 inhibitor for the first-line treatment of patients with unresectable or metastatic melanoma.
Tagrisso (Osimertinib; Formerly AZD9291)
Tagrisso is a third-generation oral tyrosine kinase inhibitor (TKI) for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR TKI therapy.
Tafinlar (Dabrafenib) and Mekinist (Trametinib) Combination Therapy
An oral BRAF and MEK inhibitor combination therapy for unresectable or advanced melanoma with BRAF V600E or V600K mutations.