Medical Devices

FDA Expands Age Range for VNS Device in Drug-Resistant Epilepsy

By June 29, 2017

Study patients reported a 50% reduction in seizure severity as well as an improvement in mood among 49% of patients. Improvements in memory and achievement were seen in 38% and 39% of patient, respectively. Moreover, patients reported a 64% reduction in seizure worry.

The Stork OTC, an FDA-Cleared, At-Home Conception Device

By June 13, 2017

Cervical cap insemination has demonstrated a pregnancy success rate of up to 20%.

Diagnostic Patch Effectively IDs Sleep Apnea

By June 05, 2017

This lightweight skin-adhesive diagnostic patch is able to record nasal pressure, blood oxygen saturation, pulse, respiratory effort, sleep time, and body position.

First-of-its-Kind Device Cleared to Treat Esophageal Birth Defect

By May 12, 2017

All 16 infants in the clinical trial of the device demonstrated a successful joining of their esophagus within 3-10 days after receiving it.

FDA Approves New MRI-Compatible Pacemaker

By February 01, 2017

Abbott announced that the Food and Drug Administration (FDA) has approved the MRI-compatible Assurity MRI pacemaker, as well as the Tendril MRI pacing lead.

Spinal Cord Stimulation May Cut Opioid Use in Chronic Pain

By January 23, 2017

Spinal cord stimulation was found to help decrease or stabilize opioid use in patients with chronic pain.

FDA: Caution with Implantable Infusion Pumps in MRI Setting

By January 11, 2017

The FDA has received reports of serious adverse events which describe medication dosing inaccuracies and other mechanical problems with the pump that have led to patient injury and death.

FDA Grants Clearance for Smallest CPAP Device

January 09, 2017

ResMed announced that the Food and Drug Administration (FDA) granted clearance for ResMed AirMini, the smallest continuous positive airway pressure (CPAP) device for patients with sleep apnea.

New Single-Use Forehead Sensor Measures Oxygen Saturation, Pulse Rate

By December 19, 2016

Masimo announced that the Food and Drug Administration (FDA) has granted clearance for the TFA-1 Single-Patient-Use Adhesive Forehead Sensor that allows clinicians to monitor patients using Masimo SET Measure-through Motion and Low Perfusion pulse oximetry from the forehead instead of a finger.

Self-Regulating 'Smart' Patch Delivers Anticoagulant As Needed

By November 28, 2016

A new study published in Advanced Materials reports on the development of a "smart" patch that can monitor a patient's blood and release blood thinners as needed to prevent the occurrence of thrombosis.

New Medical Devices FDA-Cleared for Cognition Assessment Post-Concussion

By August 22, 2016

The Food and Drug Administration (FDA) has approved the marketing of the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric medical devices to assess a patient's cognitive function immediately after a suspected brain injury or concussion.

Transcatheter Heart Valves Now Approved for Intermediate Risk Patients

By August 19, 2016

The FDA has approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves (Edwards Lifesciences) for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery.