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.

FDA Clears Remote Programming for Nucleus Cochlear Implant

By November 20, 2017

Cochlear implants often require regular programming visits with an audiologist.

Enbrel Mini With AutoTouch Now Available

By November 17, 2017

The needle stays hidden during injection and a sensor can detect placement on skin. It also includes 3 difference injection speeds, a progress bar and a speaker.

New Drug-Free Therapy Available for Arthritis Pain

By November 16, 2017

The device has 14 pre-set therapy modes designed to block acute or chronic pain or to imitate exercise recovery, endurance and muscle strength.

Device to Help Reduce Symptoms of Opioid Withdrawal Gets FDA Approval

By November 16, 2017

The FDA approval is supported by a single-arm clinical study of 73 patients undergoing opioid physical withdrawal.

FDA Clears First Smartphone Compatible Insertable Cardiac Monitor

By October 23, 2017

Patients can also track and monitor their heart rhythms at any time and view the history of their clinician transmissions without having to contact their clinic.

FDA Steps Up Efforts to Aid Med Device Production in Puerto Rico

By October 20, 2017

The FDA is working with these suppliers to secure fuel and aiding in logistical support to move critical products onto and off the island. Importing devices from outside the U.S. is also an avenue that the agency is leaving open for at-risk products, as well as allowing manufacturers to move production to alternate sites.

Robotically-Assisted Device Cleared for Surgery Use

By October 16, 2017

The device is intended to enhance the accuracy of laparoscopic instruments in manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction in laparoscopic colorectal surgery and laparoscopic gynecological surgery.

FDA Clears First Seven Tesla MRI Device

By October 12, 2017

The FDA reviewed a 510(k) premarket submission for the device by Siemens and based its clearance on comparison to a predicate device and sample clinical images.

New Implant Approved for Moderate to Severe Central Sleep Apnea

By October 10, 2017

The implantable device works by stimulating a nerve in the chest that is involved in transmitting signals to the diaphragm to stimulate breathing.

Breath Sensor, App Combo Provide Novel Approach to Smoking Cessation

By October 06, 2017

The Carbon Monoxide Breath Sensor System (COBSS) informs the user how breath carbon monoxide levels are affected by their smoking behavior.

New Glucose-Sensing Device Eliminates Need for Routine Finger Sticks

By September 29, 2017

A trial (Dunn T et al. 2017) of ≥50,000 diabetes patients, that lasted 18 months, found that FreeStyle Libre users checked their glucose on average 16 times a day.

Portable DVT Prevention Device Now Available

By September 21, 2017

As well as preventing DVT the company indicates that PlasmFlow can be used to enhance blood circulation, reduce post-operative pain and swelling, aid in the treatment of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiently and reduce of edema in the lower limbs.

FDA Clears Cefaly Device for Use During Migraine Attack

By September 21, 2017

Cefaly Acute is an external trigeminal nerve stimulator (e-TNS) approved for use under prescription.

First Duodenoscope with Disposable Distal Cap Cleared by FDA

By September 20, 2017

The Pentax ED34-i10T duodenoscope is intended to provide visualization and access to the upper gastrointestinal tract to treat bile duct disorders and other upper GI problems.

Intellis SC Stimulator Approved for Chronic Pain

By September 18, 2017

The Intellis platform records and monitors patient activity 24/7, which can be accessed by physicians to track and make treatment adjustments as needed.

Researchers Develop Portable Food Allergen-Detection System

By September 07, 2017

Most products were accurate to their stated label, however most products did contain at least 1 unspecified antigen, for instance, "brand of nut-free cookies contained gluten, whereas a gluten-free brand contained a peanut allergen," the authors write.

FDA Approves Inhaler Monitoring Device for Symbicort

By September 06, 2017

The SmartTouch for Symbicort is a monitoring device that is installed onto the patient's inhaler to track and improve medication adherence.