Devices

RECELL System Approved to Treat Severe Burns

By September 21, 2018

At Week 8 post-treatment, 92% of the burn sites treated with RECELL System achieved complete healing vs 85% of sites treated with standard-of-care, demonstrating non-inferiority.

FDA Approves New Stent System to Treat Acute Coronary Artery Perforations

By September 17, 2018

The Agency reviewed real-world data from 80 patients who received the PK Papyrus Stents, finding that the stents were delivered successfully to the perforation site in 95% of patients with successful seals seen in 73 patients 91.3% of patients.

Bloodless Hyperkalemia Test Gets FDA's Breakthrough Device Designation

By September 12, 2018

The KardiaK Platform works through a deep neural network trained to detect hyperkalemia based on data from electrocardiograms (ECG) similar to those captured by the Company's KardiaMobile and KardiaBand devices.

TMS Device Cleared to Treat Obsessive Compulsive Disorder

By August 17, 2018

Transcranial magnetic stimulation (TMS) uses magnetic fields to stimulate nerve cells in the brain.

FDA Approves Minimally-Invasive, Non-Drug Therapy for Pain Management

By August 17, 2018

Several clinical trials have demonstrated the SPRINT PNS System to be effective in reducing pain and improving quality of life.

FDA Approves First Mobile App for Use in Preventing Pregnancy

By August 13, 2018

The algorithm was designed to account for sperm survival, variation in cycle length, ovulation day, temperature fluctuations and the length of the follicular and luteal phases of the menstrual cycle.

New Device Available for Patients With Episodic Cluster Headache, Migraine

By August 02, 2018

The Sapphire has a rechargeable and reloadable fill capacity; it can be activated monthly by inputting a unique, prescription-only authorization code, delivered via a radio-frequency identification card that is mailed to the patient.

FDA Approves FreeStyle Libre 14 Day Flash Glucose Monitoring System

By July 30, 2018

The new Flash Glucose Monitoring System enables patients to wear the sensor for up to 14 days compared with the existing FreeStyle Libre System that was approved for 10-day wear.

Hailie Sensor Gets FDA Clearance for Additional Asthma Inhalers

By July 27, 2018

The Hailie sensor attaches to the asthma or chronic obstructive pulmonary disease (COPD) inhaler to monitor and help patient adherence.

FDA Clears Smartphone-Enabled Urinalysis Kit for Home Use

By July 25, 2018

The Dip.io kit works in tandem with existing smartphone cameras and a dedicated app.

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.