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Neurological | Surgical
FDA OKs Minnetronix's MindsEye Neurosurgical Access Platform
MindsEye Port is first minimally invasive, expandable port to treat of stroke, cancer, and other conditions.Business Wire 09.09.20
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Chronic Disease | Diagnostics | Software & IT
Eyenuk's Autonomous AI for Diabetic Retinopathy Screening Wins FDA Nod
First FDA cleared AI technology for autonomous detection of both more than mild and vision-threatening diabetic retinopathy.Business Wire 08.07.20
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Diagnostics
University Working on a Bulls-Eye Anemia Assessment
Smartphone app in development would detect condition via inner eyelid photo.Purdue News Service 07.23.20
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World's First Spherical Artificial Eye with 3D Retina
May actually offer sharper vision than a human eye in the future.Hong Kong University of Science and Technology 06.11.20
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Ocutrx Eyes Telemedicine Market With Advisory Boards Appointment
New board member will serve as a visionary for the company as it moves forward with new innovations in medical data, artificial intelligence, and telemedicine.Ocutrx Vision Technologies LLC 06.01.20
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Diagnostics
FDA OKs SMART Medical's G-EYE Colonoscope
Balloon technology helps control endoscope's field of view and positioning during colonoscopy.PR Newswire 05.26.20
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Diagnostics
BGI Expands EUA Label for SARS-CoV-2 RT-PCR Test
Adds automated extraction methods and additional PCR systems.PR Newswire 04.27.20
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Study: UV Technology Raises Standard in Disinfecting ORs, Medical Equipment
Hospitals use established protocols for cleaning and disinfecting ORs and medical equipment with chemical wipes after each case.Business Wire 04.20.20
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Chronic Disease | Patient Monitoring
FDA OKs Abbott's FreeStyle Libre CGM Use in Hospitals
Remotely monitors patients with diabetes to minimize exposure to COVID-19.PR Newswire 04.08.20
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FDA OKs Outset's Table System for Home Dialysis
First new device cleared for home hemodialysis in 15 years.PR Newswire 04.02.20
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R&D & Design
Supercharge Medical Device Innovation Using Effective User Preference Studies
User preference and evaluation studies have been a mainstay design tool for medical device development for decades.Philip Remedios, Principal, Director of Design & Development, BlackHägen Design 04.01.20
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Diagnostics
COVID-19 Rapid Testing Technology Developed by Oxford Scientists
The new test is based on a technique that provides results in just half an hour, over three times faster than the current method.University of Oxford 03.18.20
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FDA Suspends Foreign Inspections
The agency has postponed most foreign inspections through April, effective immediately.Food and Drug Administration 03.10.20
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FDA Approves Allergan's Durysta Glaucoma Implant
Lowers intraocular pressure in patients with open-angle glaucoma or ocular hypertension.PR Newswire 03.06.20
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Materials
A Matter of Substance: Medical Device Materials
Medtech manufacturers are leveraging cleaner, more lightweight materials to meet increasing demand for home healthcare solutions and wearable devices.Michael Barbella, Managing Editor 03.04.20
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Cardiovascular
Getting to the Heart of the Matter: An Examination of Transcatheter Heart Technologies
Transcatheter structural heart therapies stand to replace their open-heart counterparts thanks to technological innovations and expanded patient access.Sam Brusco, Associate Editor 03.04.20
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Mojo Vision Developing First True Smart Contact Lens
Company is working to bring invisible computing to consumers, enterprises and more.Business Wire 02.26.20
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FDA Offers Coronavirus Update Regarding Product Safety
The agency outlines the steps it will take to ensure the quality of foreign products.U.S. Food and Drug Administration 02.25.20
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Diagnostics | Neurological
Handheld Eye Scanner Could Help Spot Autism Earlier
New eye scan could help identify autism in children years earlier.Flinders University 02.24.20
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Patient Monitoring
Contact Lens Shows Real-Time Eye Moisture, Pressure Changes
Could be used for point-of-care diagnosis of xerophthalmia and high intraocular pressure disease.Chinese Academy of Sciences Headquarters 02.20.20
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STAAR Surgical Gains Supplemental Lens Approval for EVO Visian ICL
CE Mark addresses post-cataract-surgery myopia, hyperopia and astigmatism patients with residual refractive error.Business Wire 02.19.20
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Silk Road Medical CEO Appointed to Alydia Health Board
Newest board member holds five issued and 15 pending U.S. patents in medical devices and nanotechnology.Business Wire 02.18.20
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Surgical
TransEnterix Gains CE Mark for Senhance Pediatric Indication
TransEnterix is first to offer robotic 3 mm microlaparoscopic surgery for pediatric patients.TransEnterix 02.13.20
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Unlocking the Mystery of Corneal Healing
University of Texas bioengineers have developed a way to fabricate tiny strands of collagen in the eye.University of Texas 02.13.20
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Cardiovascular
Patient Enrollment Completed in Trial for Suture Delivery Device
Study will determine whether AtriCure's LARIAT device can help reduce the incidence of recurrent Afib.Business Wire 02.11.20
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Tryton Medical CEO Takes Temporary CFO Job at TransEnterix
Executive will temporarily assume financial duties as company looks for permanent replacement.Business Wire 02.06.20
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Machining & Laser Processing
Machining Moves to Modernize with Industry 4.0
Lasers and traditional machining are advancing and implementing Industry 4.0 features, requiring expanded skill sets.Sam Brusco, Associate Editor 01.29.20
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R&D & Design
Inventive Interaction: Medtech Research and Development in 2020
Engaging with all stakeholders—patients, clinicians, and community members alike—is key to effective medtech R&D.Michael Barbella, Managing Editor 01.29.20
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Recalibrating for 2020: Tips for a Better New Year
In 2019, I had to take a long, hard look at both my businesses and my industry to find balance and a way forward through the ripple effects of big changes.Dawn A. Lissy, President & Founder, Empirical 01.29.20
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Self-Moisturizing, Battery Powered Contact Lens
System uses electroosmotic flow (EOF), which causes liquid to flow when a voltage is applied across a charged surface.Tohoku University 01.22.20
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Patient Monitoring
Vygon Group Acquires Advanced Perfusion Diagnostics
The combination will provide physicians with a complete monitoring solution for critical care and operating rooms.Vygon Group 01.22.20
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Diagnostics | Software & IT
Signal Boost: This AI Can Help Take Magnetic Resonance Images to the Next Level
GE Healthcare's AIR Recon DL software separates signal from noise without compromising diagnostic quality or increasing scan time.Chris Noon, GE Reports 01.08.20
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ELT Sight Acquires Assets and IP of MLase AG Excimer Ophthalmic Laser System for Glaucoma Surgery
U.S. clinical trials are expected early this year.Business Wire 01.07.20
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Diagnostics | Digital Health | Surgical
Sounding Board: Looking Back at 2019 and Gazing at 2020
MPO editorial advisory board members share their thoughts on the most significant events of 2019 and what they expect to watch in 2020.Online Exclusives Sean Fenske, Editor-in-Chief 12.10.19
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Diagnostics | Neurological
Eye Test for Parkinson's Gains Breakthrough Designation
The RightEye Vision System identifies ocular tremors that may help to detect the disease at an earlier stage.PR Newswire 12.05.19
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Surgical
J&J's New Monofocal IOL for Cataract Patients with Astigmatism
TECNIS Toric II 1-Piece IOL features more surface texture and friction on IOL haptics.PR Newswire 12.05.19
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Materials
Understanding Key Processes for Mixing APIs with Silicone
The pros and cons of drug delivery and device enhancement.Online Exclusives Andrew Gaillard, Healthcare & Medical Segment Manager, Trelleborg Sealing Solutions 12.05.19
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R&D & Design
How to Minimize Color Variations in Your Medical Device
The key to making a medical device look great is to minimize obvious defects that catch the eye.Online Exclusives Dana Trousil, Medical NPI Team Lead, StarFish Medical 12.03.19
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Electronics | Software & IT | Surgical
Don’t Touch: Gesture Tech Is Reshaping How We Interact with Devices
Where can the technology improve procedures and interactions in the healthcare and medtech space?Online Exclusives Stephanie Van Ness, Sr. Marketing Communications Manager, Integrated Computer Solutions 12.02.19
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Software & IT
Survey Identifies Challenges to Improving Product Development Processes
81% of medical device companies are not using tools designed for the medical device industry in their quality management processes.PRWeb 11.26.19
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Visioneering Technologies Inc. Hires Quality Specialist
Candidate brings more than 25 years of experience working in FDA regulated environments, including FDA inspection interaction.Business Wire 11.21.19
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Glaukos Completes Patient Enrollment in U.S. IDE Trial for iStent infinite
Trial is designed to evaluate the safety and performance of the company's Three-Stent System in a standalone procedure for advanced glaucoma.Business Wire 11.21.19
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Ocutrx Unveils ORLenz for Surgery Visualization Technology in ARWear Headset
The Oculenz AR Wear headset now provides the technology surgeons have been missing for use during medical procedures.Ocutrx Vision Technologies LLC 11.20.19
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Data Show Glaukos’ iStent inject Delivers Greater IOP Reduction vs. iStent
iStent inject achieved greater absolute IOP declines with 93 percent of subjects medication-free vs. 76 percent of iStent subjects.Business Wire 11.20.19
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Contract Manufacturing | R&D & Design
5 Questions for Viant at Medica/CompaMed 2019
End-to-end capabilities, from design and development through to manufacturing, assembly, and packaging.Online Exclusives Sean Fenske, Editor-in-Chief 11.15.19
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Cardiovascular | Patient Monitoring | Software & IT
FDA OKs Ultromics' AI-Powered Decision Support System
AI automates cardiac analysis helping earlier detection of cardiovascular disease, enabling clinicians to improve patient care and outcomes.PR Newswire 11.14.19
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Ceek Women's Health Appoints Two New Board Members
Both members have more than two decades of experience in healthcare.PR Newswire 11.14.19
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Second Sight Receives $2.4 Million Grant to Develop Spatial Localization and Mapping Technology
Initiative is a joint collaboration with the John Hopkins University Applied Physics Laboratory.Business Wire 11.12.19
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Contract Manufacturing | Materials | R&D & Design
Delivering the Goods: The Evolving World of Combination Products
This extremely diverse market fosters relationships between medical device and pharmaceutical companies.Sam Brusco, Associate Editor 11.04.19
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‘If You’re Reading This, You Need to Be at This Meeting’
The AAOS/FDA/Industry Townhall is taking place March 24, 2020, at the AAOS annual meeting in Orlando.Dawn A. Lissy, President & Founder, Empirical 11.04.19
