A single-use, ambulatory, electrocardiographic monitor configured as an adhesive patch and capable of collecting data continuously for up to 14 days, intended as an alternative to Holter monitoring for patients with symptoms of arrhythmia.
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.
Tafinlar (Dabrafenib)
Also being developed for second-line treatment of metastatic BRAF V600E mutation-positive non-small cell lung cancer.
Mekinist (Trametinib)
An oral drug for the treatment of advanced melanoma in patients with BRAF V600E and V600K mutations.
NovoTTF-100A System
A noninvasive portable device that delivers alternating electrical fields to the brain via electrodes applied to the scalp to treat adult patients with glioblastoma multiforme after standard therapies fail.
Watchman Left Atrial Appendage (LAA) Closure Technology
A percutaneously implanted left atrial appendage closure device to reduce risk of stroke in patients with atrial fibrillation who cannot take warfarin.
Mobi-C Artificial Cervical Disc
An artificial cervical disc for the treatment of single-level and 2-level total disc replacement in patients with symptomatic cervical degenerative disc disease unresponsive to conservative treatments.
Imbruvica (Ibrutinib) for Mantle Cell Lymphoma
An oral once-daily monotherapy for pretreated patients with relapsed or refractory mantle cell lymphoma.
HeartWare Ventricular Assist System
A third-generation ventricular assist device for a bridge to cardiac transplant.
MitraClip Delivery System
A catheter-delivered implantable device used to perform percutaneous mitral valve repair in patients with moderately severe to severe mitral regurgitation.
Otrexup (Auto-Injector Delivery Device with Injectable Methotrexate)
Subcutaneous methotrexate delivered with a proprietary single-dose, disposable, self-administration device.