Devices

'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.

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).