An implantable neurostimulator for adjunctive therapy in adults with partial-onset seizures refractory to at least 2 antiepileptic medications.
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.
Lariat Suture Delivery Device
A percutaneously delivered suturing device for closure of the left atrial appendage intended for stroke prevention in patients with atrial fibrillation, especially those who cannot tolerate anticoagulant medications.
Gardasil 9 (Formerly V503) 9-Valent Prophylactic Human Papillomavirus Vaccine
A 9-valent prophylactic human papillomavirus vaccine.
Ibrance (Palbociclib)
An oral cyclin-dependent kinase 4 and 5 inhibitor to treat metastatic breast cancer, in combination with letrozole.
APPY1 Screening Test
A blood-based test that uses multiple biomarkers and a proprietary algorithm; intended for adjunctive use in the emergency setting for screening or triage of children and adolescents with suspected acute appendicitis.
Triferic (Soluble Ferric Pyrophosphate)
A dialysate-administered iron supplementation product to treat anemia in patients receiving maintenance dialysis for end-stage renal disease.
Rytary (IPX066)
An extended-release capsule formulation of carbidopa/levodopa for the treatment of Parkinson’s disease.
CardioMEMS HF System
A permanently implantable sensor that wirelessly monitors pulmonary artery pressures and other hemodynamic parameters, and transmits data to clinicians managing patients with New York Heart Association Class III heart failure.
Maestro Rechargeable System for Vagal Blocking for Obesity Control (VBLOC)
An intra-abdominal implantable device for the treatment of obesity in adults who have failed at least 1 supervised weight loss program within the past 5 years.
Savaysa (Edoxaban) to Reduce Risk of Stroke in Patients with Atrial Fibrillation
An oral factor Xa inhibitor for preventing stroke in patients with atrial fibrillation.