A surgically implanted hypoglossal nerve stimulator for the treatment of moderate to severe obstructive sleep apnea in patients who do not adequately benefit from continuous positive airway pressure therapy.
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.
PillCam Colon 2 Capsule Colonoscopy
A wireless endoscopic video capsule intended for imaging of the colon.
AigisRx and AigisRx R Antibacterial Envelope
An antibiotic-eluting polymer-based mesh pouch designed to hold an implantable cardiac rhythm management device and intended for the prevention of surgical site infection.
Reveal LINQ Leadless Miniaturized Insertable Cardiac Monitor
A miniature subcutaneous leadless electrocardiogram implantable loop recorder to detect infrequent cardiac arrhythmias.
Biventricular Pacing for Mild-to-Moderate Heart Failure: Expanded Indication for Medtronic Cardiac Rhythm Management Devices
Implantation of leads in both the right and left ventricles of the heart (with or without a third lead in the right atrium) in patients with mild-to-moderate heart failure who require cardiac rhythm management.
Cefaly Device to Prevent Episodic Migraine Headache
A cranial transcutaneous electrical nerve stimulator for prevention of episodic migraine headache.
Nucleus Hybrid L24 Implant System
An electric-acoustic hybrid cochlear implant system for adults with residual low-frequency hearing and bilateral severe to profound high-frequency sensorineural hearing loss, and who obtain limited benefit from bilateral hearing aids.
Laparoscopic Magnetic Sphincter Augmentation with the LINX Reflux Management System
A laparoscopically implanted sphincter augmentation device to prevent gastroesophageal reflux in symptomatic patients not achieving adequate results from current care medical therapy.
Sovaldi (Sofosbuvir)
Once-daily oral polymerase inhibitor for the treatment of hepatitis C genotypes 1, 2, 3 and 4.
Olysio (simeprevir)
A once-daily oral NS3/4A protease inhibitor for the treatment of HCV genotype 1 infection.