An intravenous antibody-drug conjugate for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.
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.
Argus II Retinal Prosthesis System
An implantable retinal stimulation system to induce visual perception in selected patients with peripheral retinal degeneration due to retinitis pigmentosa.
Pomalyst (Pomalidomide)
An oral thalidomide analog for third-line treatment of multiple myeloma.
Brainsway Deep TMS System
A noninvasive device-based therapy for treatment-resistant depression.
Amyvid (Florbetapir F 18)
A positron emission tomography radiotracer for ruling out the presence of beta-amyloid aggregates in the brains of living adults with signs and symptoms of cognitive impairment.
Acadia Anatomic Facet Replacement System
An implant consisting of 2 cobalt-chrome, pedicle screw-based articulating components designed for facet joint replacement in patients with lumbar spinal stenosis and facet joint degeneration.
Zecuity (Sumatriptan Iontophoretic Transdermal Patch, Formerly Zelrix)
A single-use, battery-powered patch that uses a mild electrical current to deliver sumatriptan through the skin to treat acute migraine headache.
MarginProbe System
A handheld device that utilizes radiofrequency spectroscopy to provide intraoperative information on the malignancy status of lumpectomy specimen margins.
Apixaban (Eliquis) for the Prevention of Stroke in Patients with Atrial Fibrillation
An oral factor Xa inhibitor for the prevention of stroke in patients with atrial fibrillation.
NeuroFlo Catheter
A single-use, intravascular, occluding catheter that is designed to temporarily divert some blood flow from the lower body to the brain, to increase cerebral perfusion in patients with acute ischemic stroke who present within 14 hours of symptom onset but too late for current care therapy.