Devices

FDA Permits Marketing of Devices to Create Arteriovenous Fistula

July 05, 2018

Two devices designed to create arteriovenous fistula in patients with CKD in need of hemodialysis

Cleared Blood Glucose Monitor Systems Not Always Accurate

June 19, 2018

"Cleared BGMs do not always meet the level of analytical accuracy currently required for regulatory clearance," the authors write.

Wearable Device Cleared for Use During Opioid Detoxification

By June 12, 2018

Electrical pulses are sent through small needles that are inserted in the ear to combat the early stages of detoxification, leading to stabilization.

First Artificial Iris FDA-Approved for Aniridia, Other Iris Defects

By May 31, 2018

In a clinical trial of 389 individuals with iris defects, 70% of patients reported a significant decrease in light sensitivity and glare.

Heart Device Recalled Due to Assembly Malfunction

May 25, 2018

The HeartMate 3™ Left Ventricular Assist System has been recalled because of a potential malfunction in the outflow graft assembly that may cause it to twist and close up over time.

Lightning Can Affect Deep Brain Stimulation Devices

May 03, 2018

Case report of 66-year-old woman whose implantable pulse generator switched off after lightning strike

FDA Approves Deep Brain Stimulation Therapy for Refractory Epilepsy

By May 02, 2018

The approval is specifically for bilateral anterior thalamic nucleus stimulation and is based on results from the SANTE study (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy).

Wearable Acid Reflux Device Now Available Over-the-Counter

By May 02, 2018

The Reza Band is worn around the neck while sleeping and applies slight external pressure to the cricoid cartilage area, which increases the internal pressure of the upper esophageal sphincter (UES).

Can Smartphone App Help Med Adherence in Hypertension?

April 18, 2018

The researchers found that the mean score on the Morisky medication adherence scale improved by 0.4 among intervention participants and remained unchanged among controls (between-group difference, 0.4; 95% confidence interval, 0.1 to 0.7; P=.01) after 12 weeks

FDA Approves Unique Device for Diabetic Retinopathy Screening

By April 11, 2018

This is the first device authorized for marketing that provides a screening decision without the need for clinician interpretation.

Contact Lenses With Light-Adaptive Technology Get FDA Approval

By April 11, 2018

The contact lenses contain a photochromic additive that adapts the amount of visible light filtered to the eye based on the amount of UV light to which they are exposed.

Noninvasive Brain Stimulation May Help Prevent Migraines

April 04, 2018

"This open label study suggests that sTMS may be an effective, well-tolerated treatment option for migraine prevention," the authors write.

Dexcom G6 Integrated Continuous Glucose Monitoring System Gets FDA Approval

By March 27, 2018

The Dexcom G6 iCGM system determines blood glucose levels in patients 2 years of age and older.

Smartwatch May Be Able to Passively Detect Atrial Fibrillation

March 23, 2018

In the external validation cohort of 51 patients undergoing cardioversion, the algorithm's sensitivity and specificity were 98.0 and 90.2%, respectively. Using self-report of persistent AF in ambulatory participants for exploratory analysis, the C statistic was 0.72, sensitivity was 67.7%, and specificity was 67.6%.

Wearable System Provides 24-Hour Ambulatory GI Monitoring

By March 22, 2018

The wearable system was found to work as well as more invasive methods.

Tiny Tooth Sensor Monitors Dietary Intake, Sends Info to a Mobile Device

By March 22, 2018

When the central layer of the sensor comes in contact with 1 of the pre-defined nutrients (in the current case salt, glucose or alcohol), it's electrical properties change and the sensor absorbs and transmits a different spectrum of radio waves with varying intensity.

Implantable Sensor Relays Real-Time Personal Health Info

March 22, 2018

The researchers described the use of functionalized soft, porous hydrogel scaffolds with luminescent chemistries and demonstrated their functionality in the body for over 4 years.

Virtual Reality Distraction May Help Reduce Procedural Pain

March 15, 2018

The researchers found that VR was effective for reducing procedural pain, even in patients subjected to extremely painful procedures, such as those with burn injuries undergoing wound care and physical therapy.

Researchers Develop Smartphone Device to Measure Blood Pressure

By March 09, 2018

When the app is turned on, users press their fingertip against the sensor while the app informs them if the pressure being applied is requisite, and in turn the app provides the blood pressure reading.

FDA Approves Smallest Ever Mechanical Heart Valve

By March 07, 2018

Findings from a single-arm study (N=20) of pediatric patients with serious heart failure (aged 1.5 weeks to 27 months) at the time of mitral valve implant were reviewed by the Agency. Study data showed a 69.3% probability of survival post-implant and a 66.8% probability of not experiencing a valve-related adverse event.

Treatment Window for Using Clot Retrieval Device Now Expanded

By February 15, 2018

The Trevo device is inserted via a catheter into the blood vessel to the site of the clot. The end portion of the device expands (up to 3-6mm diameter) and grips the clot, allowing the physician to pull it back through the vessel along with the device.

FDA Clears Smart Watch for Epilepsy Management

By February 06, 2018

Embrace uses advanced machine learning to monitor for grand mal or generalized tonic-clonic seizures, and sends an alert to summon caregivers' help.

GammaCore Approved for the Acute Treatment of Migraine Pain

By January 29, 2018

The new approval for migraine patients was supported by the PRESTO trial, a multicenter, randomized, double-blind, sham-controlled trial.

MRI Seems Safe for Patients With Legacy Pacemaker, ICD System

December 28, 2017

No long-term clinically significant adverse events reported among 1,509 patients

'Smart' Insulin Pen System for Humalog, Novolog Available

By December 14, 2017

The InPen is for use with U-100 Lilly Humalog and Novo Nordisk Novolog rapid-acting insulin and indicated for persons aged 12 years and older.

Vercise Deep Brain Stimulation System Approved for Parkinson's Disease

By December 12, 2017

The FDA's approval was based on results from the 'Intrepid' study, the first multi-center, prospective, double-blind, randomized sham-controlled study of DBS for Parkinson's Disease in the U.S.

FDA Expands Use of DESCRIBE PFD Patch for Laser Treatment of Tattoos

By December 04, 2017

The Patch, which is placed over tattoos prior to removal with a laser, allows physicians to treat tattoos more efficiently by enabling rapid multiple laser passes in a single treatment session.

FDA Approves KardiaBand for Apple Watch

By November 30, 2017

The first FDA-cleared medical device accessory for Apple Watch, KardiaBand can record an EKG in 30 seconds with just a touch of its integrated sensor.

Two New Migraine Treatment Devices Available

By November 29, 2017

The Food and Drug Administration (FDA) approval was based on several studies that demonstrated 1 hour of use with Cefaly Acute could relieve or stop the migraine headache.

FDA Approves Intraocular Lens That Can Be Adjusted Post-Cataract Surgery

By November 27, 2017

First medical device system that can make small adjustments to the artificial lens' power after cataract surgery so that the patient will have better vision when not using glasses.