Devices

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.

One-Step Drug Test Cup Gains FDA Clearance for OTC Use

By August 16, 2017

The FDA's marketing clearance applies to 13 commonly abused drugs; there are multiple cut-off options available for certain drugs.

FDA: Deaths Following Intragastric Balloon Placement for Obesity

By August 10, 2017

Two additional reports of death within the same time period may possibly be related to balloon placement as well.

'Groundbreaking' Technology Heals Serious Injuries with a Single Touch

By August 09, 2017

"By using our novel nanochip technology, injured or compromised organs can be replaced. We have shown that skin is a fertile land where we can grow the elements of any organ that is declining," said Dr. Chandan Sen.

Non-Invasive ECG Device Gets FDA Clearance

By August 09, 2017

Clinical data from the Turbulence study (n=1,807) showed CADence had comparable performance to a SPECT nuclear stress test in excluding obstructive CAD in patients with chest pain and risk factors.

FDA Clears Non-Invasive Device to Treat Chronic Intractable Pain

By August 03, 2017

The Stimpod NMS460 includes a nerve-mapping pen-like probe which allows practitioners to locate nerves and evaluate the treatment progress.

'Smart' Undergarment Helps Reduce Stress on the Lower Back

By August 02, 2017

When wearing the clothing lower back activity was reduced by an average of 15 to 45%.

FDA Clears First MRI Device for Neonatal Imaging in NICU

By July 21, 2017

The Embrace Neonatal MRI System is specifically designed for imaging of the neonatal head (head circumference up to 38cm and weight of 1 - 4.5kg).

Drug-Free Cluster Headache Therapy Now Available

By July 18, 2017

The Food and Drug Administration (FDA) approved gammaCore in April after efficacy was demonstrated in two clinical trials involving over 200 patients with episodic cluster headaches (ACT1 and ACT2).

FDA Clears At-Home Light Therapy Device for Psoriasis

By July 13, 2017

A clinical trial (Pfaff S et al. 2015) of 47 individuals with mild psoriasis found significant improvement in change from baseline of Local Psoriasis Severity Index in patients receiving UV-free blue light home treatment.

Cooling Cap FDA-Cleared to Reduce Chemotherapy-Associated Hair Loss

By July 05, 2017

A study of 122 women with Stage I and Stage II breast cancer undergoing chemotherapy particularly associated with hair loss. The study showed that over 66% of patients using DigniCap reported losing less than half their hair.

Novel Tear Production Stimulator Given All Clear by FDA

By April 25, 2017

Safety and efficacy of the TrueTear device were demonstrated in two clinical studies in a total of 145 individuals with aqueous deficient dry eye.

Medical Device Recalls Assessed for Judgement Bias

March 06, 2017

The characteristics of the signal in user feedback of adverse events associated with medical devices and the situated context of decision makers correlate with judgement bias in reacting to these adverse events.

Is High-Frequency Stimulation Superior for Back Pain?

November 10, 2016

High-frequency electrical stimulation of the spinal cord may relieve severe chronic back pain more effectively than conventional low-frequency stimulation, according to research published in the November issue of Neurosurgery.

Drug-Free Therapy for RLS Available in Pharmacies

By November 08, 2016

Medi USA announced the availability of the restiffic compressive foot wrap for the treatment of restless legs syndrome (RLS).