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.

Ultrasafe Plus Passive Shielding Rc Ps Psp 0616 0126
BD: Passive Needle Guard
New system extends BD UltraSafe Plus™ needle guard platform capabilities to deliver up to 2 mL and 30 cP biologics – enhancing self-administration.
Nov 17th, 2021
Screen Shot 2021 11 11 At 3 44 35 Pm
BIOMEDevice Silicon Valley Sets Speaker Lineup to Address Infusion of Digital Health, IVD, and Automation in Healthcare
Returning to Silicon Valley, the event geared toward advancing the digital health and personal diagnostics development sector reveals a robust lineup of speakers from Google, Oracle, Stanford University, Samsung SDSA, MedSec, and more.
Nov 11th, 2021
Hp 111701 Udi 0 png
Safety Factors for Ethylene Oxide Sterilization: Patient, Worker, and Environment
The common medical device sterilization method requires optimization, particularly with potential regulatory changes on the horizon. Emissions limits could become more stringent by as much as 90% per one technical affairs VP.
Oct 28th, 2021
Boehringer Ingelheim - Aservo EquiHaler
Pharmapack Europe 2021 Award Winners Announced
The Pharmapack Awards celebrate the latest innovations in connected devices, wearables, packaging, sustainability, eco-design, patient-centric design, and animal health. Scroll through the gallery to see the winners.
Oct 22nd, 2021
Paris-based Laboratoires VIVACY develops, produces, and distributes medical injectables. Due to a boom in aesthetic procedures, production volume is growing strongly, necessitating packaging automation.
Laboratoires VIVACY Reduces Production Waste by 17%, Cuts Logistics Costs with New Packaging Line
The new blister packaging line for aesthetic medical products from KOCH boosts quality and while cutting waste.
Oct 18th, 2021
Download: Life Science Logistics Playbook
Sponsored
Download: Life Science Logistics Playbook
Get tips on preventing excursions and waste, developing a validation master plan, characterizing shipping lanes, and more.
Oct 17th, 2021
Charbel Tengroth, MD of Tengroth Consulting will speak at Pharmapack Europe on “Current trends in biosimilars and impacts on autoinjector development.”
Q&A: Trends Impacting Autoinjector Development
A consultant says the rise of drugs that treat or help alleviate chronic conditions 'has meant that there is also an increase in competition from device manufacturers looking to develop therapy-specific devices.”
Sep 22nd, 2021
Sustainability index for packaging markets
Pharmapack Report 2021: U.S. Leads on Drug Device Innovation but Trails Europe on Sustainability
Event agenda to track trends in sustainability, patient-centered device design and biosimilars and autoinjectors
Sep 20th, 2021
Trend 5 At 615
Technipaq Partners with DuPont™ Tyvek® and Freepoint Eco-Systems to Reduce and Recycle Medical Packaging Plastic Waste
Sep 19th, 2021
Lidding
Lidding Technology for Combination Products
Amcor launches a proprietary healthcare lidding technology designed for use with combination products—those consisting of two or more regulated components (device, drug, or biologic).
Aug 26th, 2021
'The Nelipak Healthcare Packaging team is grateful to be acknowledged in the AmeriStar Awards for our innovative design,' said Bob Jacobs, team leader product design, Nelipak.
Nelipak Healthcare Packaging Honored with a 2021 AmeriStar Award
Company’s Miltenyi CliniMACS Prodigy tubing set recognized in medical device category
Aug 16th, 2021
Hp 107536 Surgical Tools Copy
Manufacturers To Highlight Medaccred Accreditation At Medical Design And Manufacturing (West) 2021
Aug 11th, 2021
7cfac987 27ff 2ecd 06fb 8d5674922a2a
Vacuum Sealer
The PVT Plus Med from PAC Machinery is a validatable vacuum sealer designed for medical and other critical packaging applications that require precise control of all sealing process parameters.
Aug 3rd, 2021
Hp 107536 Surgical Tools Copy png
3 Fast Facts: Cohesive Peel Technology
How can a cohesive peel system help with variability in peel strength?
Jul 27th, 2021
Screen Shot 2021 07 22 At 12 53 32 Pm
BIOMEDevice Boston Reveals 2021 Center Stage Content
The in-person experience will feature keynotes, sessions, and panels from MEDX Ventures Group, Johnson & Johnson Innovation Center, Vanguard Health, and E25Bio.
Jul 22nd, 2021
Prior to the MGS assembly module, bulk actuators are dumped into a hopper; a centrifugal bowl is utilized to singulate and orient them.
Metered Dose Inhaler Line Centralizes Control from Canisters Through Pallets
A deep dive into a “one machine” concept for a metered dose inhaler line, with system integration for 18 pieces of machinery and components from a variety of OEMs.
Jul 20th, 2021
Westfall Chicago Building Pic Hr Webready
Westfall Technik Opens New Medical Molding Plant, Clean Room in Chicago
Move is the latest in its expansion of North American clean-room capabilities.
Jul 16th, 2021
Devices Getty Images 624567292 Sep Oct 2018
FDA Final Guidance: Form and Content of the Unique Device Identifier (UDI)
The document is intended to assist labelers and FDA-accredited issuing agencies in complying with unique device identifier (UDI) labeling requirements, including by clarifying FDA’s interpretation of certain requirements under 21 CFR 801.40.
Jul 10th, 2021
Tekni Plex Healthcare
Tekni-Plex Presents Webinar on Breathable Packaging Microbial Barrier and Coating Options
Webinar will cover using coating options to specify the right microbial barrier for specific breathable sterile medical packaging applications.
Jul 1st, 2021
Biome Device
BIOMEDevice Returns to Boston This September 21-22
Jun 28th, 2021
More in Medical device/Packaging
Pharmapack 2020 0040
Drug Delivery Innovation Across Europe Improves for Third Consecutive Year Ahead of Pharmapack Europe
Explosion of innovation expected with Pharmapack Awards now open for entries.
Jun 28th, 2021
The new document is a freely available and peer-reviewed supplement to AAMI’s journal, BI&T.
AAMI: New Paper on Industrial Sterilization of Reusable Medical Devices
Says J&J's Terra Kremer: This covers the reproducibility of device processing extraction efficiencies during validation and how to control test variables to deliver a consistent testing outcome during cleaning validation of reusable medical devices, .
Jun 24th, 2021
Iso Logo
Aptar CSP Technologies Earns ISO Quality Certifications for Medical Device Production
Certification affirms the company’s quality management systems meets ISO requirements.
May 4th, 2021
3
Celebrating Sterile Packaging Day with Dr. Henk Blom and Marie Tkacik
“Sterile Packaging Day will broadly communicate the message that packaging is critical and aims to elevate packaging engineers in the product development cycle,' says Henk Blom. A series of educational webinars will also be provided.
Mar 10th, 2021
Screen Shot 2021 03 04 At 10 25 32 Am
PAXXUS: Visual Seal-Assurance System
PAXXUS’ patented Chameleon technology is now available for use with uncoated Tyvek .
Mar 4th, 2021
I Stock 000021206803 Large
Modular: The Modern Way of Manufacturing Injectables
Flexibility allows manufactures to meet the needs of the growing and versatile injectables market.
Mar 4th, 2021
Pro Mach Logo 600b0fdbdf105
ProMach Acquires Serpa Packaging Solutions
The acquisition of Serpa Packaging Solutions expands ProMach’s secondary packaging solutions for pharmaceutical applications and enhances its turnkey line integration capabilities.
Feb 2nd, 2021
World Star Award 01
Placon Steps into 2021 with WorldStar Award
Placon has been announced as WorldStar award winner in the medical and pharmaceutical category for the second consecutive year.
Jan 20th, 2021
Getty Images 1268181219
Med Device Market Shifting Business Models to Automation and Technology
Four out of five medical device companies interviewed for a new PMMI white paper believe automation and other technological advances are one of the biggest changes to manufacturing in recent years.
Jan 4th, 2021
Nurse Panel 1 Copy 5eab1b2e13ea2
Counting Down the Top 10 Articles of 2020 - #6: Nurses Reveal Their Packaging Pain Points
Join us as we look back at the most-read Healthcare Packaging stories of 2020. Coming in at #6: we cover the ever-popular nurses’ panel at HealthPack, in which device packaging is reviewed from the user perspective.
Dec 25th, 2020
Screen Shot 2020 12 07 At 9 22 05 Am
Pharmaceutical & Medical Devices | Webinar | Dec. 9
3 out of 4 pharmaceutical and medical devices companies predict spending more on capital equipment in the next 12-24 months. Learn more about PMMI Business Intelligence findings for this market.
Dec 7th, 2020
Production of a metal-free syringe: The pin used to shape the cone with the new technology is no longer made from the tungsten usually used or an alternative metal, but instead of a specific ceramic.
Gerresheimer: Syringes for Biotechnologically Manufactured Active Ingredients
Metal-free glass syringes produced with a patented innovative production technology designed to handle the needs of these ingredients.
Dec 3rd, 2020