NeuroAD is noninvasive system that combines repetitive transcranial magnetic stimulation with cognitive training to treat mild-to-moderate Alzheimer disease. Transcranial magnetic stimulation (TMS) is a neurostimulation and neuromodulation method that uses electromagnetic induction of electric fields in the brain. TMS works by passing a current through a wire coil placed on t…
Horizon Scanning
It is a challenge for health plans and clinicians to know what emerging technologies are in the preapproval phase and what their clinical, financial, and risk impacts might be. This is where we come in.The Hayes Horizon Scanning Solution identifies innovative and potentially disruptive health technologies that are in various stages of the regulatory approval process. Our Research Analysts continually investigate new technologies that are on the horizon or in the early stages of clinical investigation, as well as the testing of existing technologies that may be seeking approval for new clinical applications. Hayes Horizon Scanning helps you track emerging technologies before you need to make decisions. Accessed through the Hayes Knowledge Center, Hayes Horizon Scanning addresses the following fundamental questions to help our clients forecast emerging technologies:
- Is this emerging technology new or replacing an existing technology?
- Where is this technology in the FDA regulatory process?
- When will this technology be commercially available in the market?
- What is the projected use, cost, and financial impact of this technology?
NeuroAD Therapy System for Alzheimer Disease
NeuroAD is noninvasive system that combines repetitive transcranial magnetic stimulation with cognitive training to treat mild-to-moderate Alzheimer disease. Transcranial magnetic stimulation (TMS) is a neurostimulation and neuromodulation method that uses electromagnetic induction of electric fields in the brain. TMS works by passing a current through a wire coil placed on t…
DownStream System for SuperSaturated Oxygen Therapy
The SSO2 therapy system is intended for use in acute anterior myocardial infarction patients following percutaneous coronary intervention (PCI) performed within 6 hours of symptom onset. The system delivers supersaturated oxygen mixed with the patient’s own blood to the left anterior descending coronary artery, with the goal of further reducing…
Early Bird Bleed Monitoring System
The Early Bird Bleed Monitor System (EBBMS) is comprised of a standard vascular access sheath with embedded sensors that measure the electrical resistance across the blood vessel. By sensing a change in the vessel’s electrical resistance, the EBBMS is designed to detect and monitor bleeding from a blood vessel accidentally injured during endovascular procedures. When there is…
Early Bird Bleed Monitoring System
The Early Bird Bleed Monitor System (EBBMS) is comprised of a standard vascular access sheath with embedded sensors that measure the electrical resistance across the blood vessel. By sensing a change in the vessel’s electrical resistance, the EBBMS is designed to detect and monitor bleeding from a blood vessel accidentally injured during endovascular procedures. When there is…
Ryplazim (Plasminogen) for Congenital Plasminogen Deficiency
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.
Epidiolex (Cannabidiol) for Epilepsy
Epidiolex is an oral liquid formulation of a highly purified extract of cannabidiol (CBD). CBD is a non-psychoactive component of Cannabis sativa (marijuana). It is approved by the Food and Drug Administration for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients 2 years of age and older.
Braftovi (Encorafenib) plus Mektovi (Binimetinib)
Braftovi (encorafenib) plus Mektovi (binimetinib) is new BRAF-MEK inhibitor combination regimen approved by the Food and Drug Administration (FDA) for the treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
Xhance Fluticasone Propionate Exhalation Delivery System
Xhance (formerly OPN-375) is a drug-device product for the treatment of nasal polyposis in adults. The product combines a novel, closed palate, bidirectional drug delivery platform with fluticasone propionate, which is a topical steroid. The drug delivery device is powered by the user’s own breath. It has both a mouthpiece and a sealing nosepiece designed to expand the upper part of the nasal …
Tibsovo (Ivosidenib) for Acute Myeloid Leukemia
Tibsovo is a first-in-class oral targeted small-molecule inhibitor of mutant isocitrate dehydrogenase-1 (IDH1) designed to decrease accumulation of the oncometabolite D-2-hydroxyglutarate (2-HG), resulting in reduced blast counts and increased percentages of mature myeloid cells in patients with relapsed or refractory acute myeloid leukemia (AML).