FDA Approves First Prosthetic Iris

The FDA has approved the first stand-alone prosthetic iris that could improve the vision and appearance of damaged eyes.

Jun 7th, 2018

Artificial Iris / Image: HumanOptics

Artificial Iris / Image: HumanOptics

A recent CBS News article contained good news for anyone with a damaged iris in their eye: the FDA has just approved the first artificial iris. The iris is responsible for regulating how much light enters the eye, and those with compromised irises often suffer from light sensitivity and other vision problems. The CustomFlex Artificial Iris can be surgically inserted into the eye to correct the issues and improve the appearance of the eye.

The artificial iris is composed of thin, foldable medical-grade silicon that’s custom-fitted and colored for each individual patient. The device was deemed safe and effective after a study found that it decreased light sensitivity and improved health-related quality of life in 70% of participants.

Partnership to Manufacture the Emergency-use ‘Maverick’ Auto-injector

Partnership to Manufacture the Emergency-use ‘Maverick’ Auto-injector

The glass cartridge-based auto-injector possesses a needle-retraction safety feature and is mechanically robust.

Hulio wins PDA award for device innovation.

PDA’s First Drug Delivery Innovation Award Winners at 2019 Universe of Pre-Filled Syringes and Injection Devices Conference

One award winner includes a thinner needle to reduce injection pain, while a partnership resulted in a precise microliter dosing syringe.

Stevanato Inspection

Competitive Drugs Demand Innovative Delivery Devices

Vial and syringe might be fine if you’re the only game in town. But as competition grows, so does the demand to make drug delivery easier and more convenient for patients. In many cases, your best bet is to partner for that innovation.

FDA Comments on Potential Device Shortages in the Face of ETO Facility Interruptions/Closures

FDA Comments on Potential Device Shortages in the Face of ETO Facility Interruptions/Closures

Acting Commissioner Sharpless: “…in addition to our shortage mitigation efforts, we have also been addressing the broader need for innovation and improvements to medical device sterilization techniques in general.”

2-for-1 Prosthetic Control / Image: Johns Hopkins

Man Mind-Controls 2 Prosthetics at Once For the First Time

For the first time, researchers have proven that it’s possible to simultaneously control two separate prosthetic arms via brain-machine interface.

Haselmeier's Axis D pen-injector

Stevanato Group signs an Exclusive Agreement with Haselmeier to License Axis-D Pen-injector Technology and Intellectual Property for the Therapeutic Area of Diabetes Care

Sub-assembly and final assembly equipment to be supplied by Stevanato Group Operations in Denmark in preparation for global launching.

Aptar's Nasal Unidose Device

Aptar Pharma: Nasal Unidose Device

The device has been approved for Tosymra Sumatriptan Spray by the FDA.

Wearable VR Skin / Image: EHFPL

New Wearable Skin Enhances VR

Swiss scientists have developed an ultra-thin second skin that gives the wearer touch feedback without vibration.

MemorEMTM / Image: NeuroEM

New Alzheimer’s Helmet Reverses Memory Loss

A new wearable head device offers in-home non-invasive treatment to reverse memory loss suffered by patients with Alzheimer’s disease.

Medical Drone / Image: nurse.org

Montreal is Testing Drones as Medical Delivery Vehicles

Emergency physicians in Montreal are testing unpiloted robotic aircrafts to deliver blood supplies and defibrillators.

NUsurface Meniscus Implant / Image: Active Implants

First Artificial Meniscus is an FDA Breakthrough Device

The FDA has designated the first artificial meniscus implant a breakthrough device, expediting its review process.

Anti-Balding Cap / Image: Alex Holloway

New Electric Patch Aims to Reverse Male Balding

A team at UW Madison has developed a wireless patch that adheres to the scalp and generates electric pulses to combat balding.

Live at PACK EXPO Las Vegas: IOPP Fundamentals of Medical Device Packaging Course Development

More than 45 members of the medical device community took Monday afternoon at the show to attend a FORUM session to help shape a new course for junior engineers and new entries to the medical device community.

Self-Lubricating Condom / Image: Shutterstock

Bill Gates Funded a New Condom to Fight Sexually Transmitted Diseases

Scientists have developed a new self-lubricating condom that could increase usage and decrease STDs and unwanted pregnancies.

Cap-Lock from Schreiner MediPharm protects syringes against undetected tampering attempts.

Schreiner MediPharm: Opening Indication for Prefilled Syringes

The Cap-Lock is designed to seal prefilled syringes to prevent undetected opening of the cap.

Dreem 2 Headband / Image: Dreem

This New Wearable Treats Insomnia

The Dreem 2 headband measures sleep activity and delivers sound vibrations to sooth patients to sleep.

Smart Inhalers Market Growth Expected to Skyrocket according to report

Smart Inhalers Market Growth Expected to Skyrocket

The global smart inhalers market size was valued at $34 million in 2018 and is estimated to reach $1.4 billion by 2026, growing at a CAGR of 58.4% from 2019 to 2026.

Skin Patch / Image: EurekAlert!

New Skin Patch Delivers Vaccines and Drugs in Under 1 Minute

Researchers have created a fast-acting skin patch that delivers medication to attack melanoma cells.

FDA / Image: FiercePharma

FDA Says No More Reusable Duodenoscopes

After years of sterilization issues, the agency is urging device makers to transition to disposable duodenoscopes.

Medical Drone / Image: Ali Al-Naji

Medical Drones are Faster Than Ambulances

A drone system reached fake patients 90 to 120 seconds faster than an ambulance in trials conducted in a busy city in Iraq.

More in Medical device packaging

Prosthetic made from plastic bottles. / Image: DMU

Researchers Upcycle Plastic Bottles into Prosthetic Limbs

Artificial limbs made from water bottles kill two birds with one stone: combatting pollution and saving on costs.

EpiPen / Image: Getty

Illinois Now Requires Insurance Companies to Cover EpiPens

Illinois will become the first state to require insurance companies to cover EpiPen injectors for kids.

Tekni-Plex's lameplast vials

Tekni-Plex exhibits unit-dose pharma packaging solutions, new films for medical devices at Pack Expo Las Vegas

The latest pharmaceutical unit-dose package capability and new films for medical device applications will be featured by Tekni-Plex’s Tekni-Films business unit at Pack Expo Las Vegas, September 23-25, Las Vegas Convention Center, Booth N206.

SoomSafety Mobile App for Medical Device Recalls

New Mobile App Notifies Patients, Caregivers, and Nurses of Medical Device Recalls

Using barcode and knowledge graph technologies, the app sits on top of all other databases to provide complete and current information to users.

Ever Pharma's Micro-Infusion Pump, D-mine

Ever Pharma Improves Parkinson Patients’ Experience through Micro-Infusion Pump

Wearable micro-infusion pump D-mine is designed to be more easily handled and safe for patient use to promote greater independence.

Digital Heart / Image: Shutterstock

The FDA Wants a Virtual Heart to Test Medical Devices

The FDA is seeking computational software that models the human heart to test medical devices and therapies.

Wearable Throat Device / Image: Artificialth

Wearable Artificial Throat Aims to Help Mute People ‘Speak’

Scientists have developed a wearable artificial graphene throat that attaches to the neck and transforms throat movements into sound.

Red Wine / Image: Public Domain

Scientists Are Using Red Wine to Make Wearables. Wait, What?

Tannic acid extracted from red wine is helping a team at University of Manchester create more durable and flexible wearable devices.

Elon Musk / Image: Teslarati

Elon Musk and Neuralink Are Making Progress

The tech billionaire announced his controversial startup Neuralink is planning to test their brain-computer interface in 2020.

Moxi, the hospital robot / Image: Fast Company

Hospitals Are Using Robots to Aid Nurses

Diligent Robotics created a robot named Moxi to help nurses complete tasks that don’t involve patient interaction.

Spine Injury / Image: Michigan Engineering

University of Michigan Creates EpiPen for Spine Injuries

Injecting nanoparticles into the spine can dampen the body’s immune response to spinal cord injuries and prevent paralysis.

E-Tongue / Image: IBM

IBM Created an ‘E-Tongue’ That Identifies Flavors

IBM Hypertaste is a portable device equipped with sensors that can taste and identify different liquids.