A soluble guanylate cyclase stimulator for the promotion of vasodilation in adult patients with pulmonary arterial hypertension.
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.
UroLift System
Permanent prostatic urethral lift implants to relieve blocked urine flow in men age 50 and older with benign prostatic hypertrophy.
Adempas (Riociguat) for Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
A soluble guanylate cyclase stimulator for the treatment of persistent or recurrent chronic thromboembolic pulmonary hypertension after pulmonary endarterectomy or for inoperable chronic thromboembolic pulmonary hypertension in adult patients.
Dominion Vi Scanner (DViS)
A mobile “O-arm” for real-time 3-dimensional imaging with potential applications in critical care, trauma and emergency, orthopedic, image-guided, and interventional imaging.
MAKOplasty Total Hip Arthroplasty
A preoperative 3-dimensional image reconstruction system with a surgeon-interactive robotic arm used to assist in planning and placing the joint implant during total hip arthroplasty.
MAKOplasty Partial Knee Resurfacing
A preoperative 3-dimensional image reconstruction system with a surgeon-interactive robotic arm used to assist in planning and performing partial knee resurfacing.
Xofigo, formerly Alpharadin (Radium-223 Chloride)
An injectable alpha-emitting radiopharmaceutical to treat patients with bone metastasis from castration-resistant prostate cancer.
Apixaban (Eliquis) for Treatment of Acute Venous Thromboembolism (VTE) and VTE Secondary Prevention
An oral factor Xa inhibitor for the treatment and secondary prevention of venous thromboembolism.
Apixaban (Eliquis) for Prevention of Venous Thromboembolism Following Total Hip or Knee Replacement
An oral factor Xa inhibitor for the prevention of venous thromboembolism following hip or knee surgery.
Neuropsychiatric EEG-Based Assessment Aid (NEBA) System
An electroencephalographic test that uses a biomarker to assist in the diagnosis of attention-deficit/hyperactivity disorder in children and adolescents.