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Neurological
Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation
Next-generation digital therapeutic is designed for the treatment of Alzheimer’s disease.Business Wire 01.14.21
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Exero Medical’s Smart Sensor Granted FDA Breakthrough Designation
The product provides data on internal tissue healing in the gastrointestinal tract.Exero Medical 01.11.21
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Preparing Your Design Controls for FDA Approval
Design controls are a set of procedures to build into medical device design and development.Online Exclusives Adam Freeman, Freelance Medical Device and Combination Product Design Specialist, Kolabtree 12.09.20
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R&D & Design
New Project-Based Rapid Precision Prototyping Program
Your First Step Is the Most Important
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Machine Solutions Acquires Beahm Designs
Expands its catalog of catheter manufacturing equipment and broadens its engineering resources.Machine Solutions Inc. 11.20.20
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Sommetrics' aerSleep II Sleep Apnea Treatment Earns Breakthrough Designation
aerSleep II applies negative pressure over the external surface of the neck to hold airway open during sleep.Business Wire 11.17.20
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R&D & Design
How Design Controls Can Prevent Medical Device Recalls
Incorporating risk management early in development will help eliminate problems before they impact the product’s manufacturing lifecycle.Online Exclusives Ramya Sriram, Digital Content Manager, Kolabtree 11.16.20
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FDA Grants Breakthrough Device Designation for Magnetic Anastomosis Technology
The innovation is designed to help surgeons deliver less invasive solutions through magnetic compression anastomosis.GI Windows Medical Corp. 11.13.20
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R&D & Design
Medtech Makers: Collaborating with Full-Service Design and Development Providers
Spectrum Plastics Group’s Paul Melnychuck speaks about the advantages of working with a full-service supplier and contract manufacturer.
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Electronics
Big Data's Role in Sensor Design
Insight into device use is driving trends in miniaturization, low-power options, and conversion to digital sensing.Online Exclusives Michael Barbella, Managing Editor 11.09.20
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3D/Additive Manufacturing
Additive Manufacturing: Debinding Fluids Must-Haves
As the pressure to produce more complex biomedical parts increases, medical device manufacturing using 3D printing is gaining widespread acceptance.Venesia Hurtubise, Technical Chemist, MicroCare Medical 11.04.20
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Chronic Disease
FDA Grants Breakthrough Device Designation to Cala Trio
Aims to treat action tremors in the hands of adults with Parkinson's disease.Cala Health 10.22.20
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Considerations in Designing 'Fail-Safe' Motor Drive Circuits
Products must be constructed to fail in a safe manner to protect both patients and physicians.Online Exclusives Michael Barbella, Managing Editor 10.15.20
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Randall Sword Named CEO of Catheter and Medical Design
Joins following his previous position as president and CEO of N2 Biomedical.Catheter and Medical Design LLC 10.07.20
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Materials
Beyond the Status Quo: Eight Often-Overlooked Areas of Medical Textile Product Development
Companies have been successful in bringing devices to market that support MIS approaches in part because of biomedical textile materials.Shanzeh Farooqui, Development Engineering Lead, Cortland Biomedical 10.01.20
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Device Success Contingent Upon Flexible Circuit Design
Defining the requirements unique to the medical application is essential before starting the design.Online Exclusives Michael Barbella, Managing Editor 09.30.20
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R&D & Design
AdvaMed and StartX Announce Partnership
Helps medtech entrepreneurs accelerate innovation.AdvaMed 09.21.20
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Patient Monitoring
Abbott Introduces World's First Glucose Biosensor Designed for Athletes
The firm is collaborating with Supersapiens in launch of the Libre Sense Glucose Sport Biosensor in Europe.PR Newswire 09.18.20
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Electronics
Designing for Safety with Specialist Resistors
How resistors for high voltage and surge medical applications reduce risk in the new ‘healthcare anywhere’ scenario.Online Exclusives Stephen Oxley, Business Development Engineer, TT Electronics 09.14.20
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Digital Health
FDA Breakthrough Device Designation Granted for Algorithm to Predict Acute Kidney Injury
The algorithm monitors hospitalized patients and can predict acute kidney injury more than a full day before patients meet the clinical criteria for diagnosis.Business Wire 09.08.20
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Researchers Redesign the Face Mask to Improve Comfort and Protection
Combines a barrier filtration material with a stretchable fabric to hold it in place.John Toon, Georgia Institute of Technology 09.04.20
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Cardiovascular
PQ Bypass Earns Breakthrough Designation for Fully Percutaneous Femoral-Popliteal Bypass Device
First device of its kind to treat extremely long, complex blockages in the superficial femoral artery, according to the company.Business Wire 09.03.20
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R&D & Design
The Human Factors of Aesthetics
Exploring the relationship between a device’s aesthetic, human factors engineering, and purposeful design.Sean Hägen, Principal, Director of Research & Synthesis, BlackHägen Design 09.01.20
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Contract Manufacturing | R&D & Design
Trends for Medtech Contract R&D and Manufacturing
Over the past 10 years, medtech manufacturers from startups to giants have grown their levels of outsourcing to contract R&D and manufacturing partners.Maria Shepherd, President and Founder, Medi-Vantage 09.01.20
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Machine Solutions Acquires Crescent Design
The deal marks Machine Solutions’ fifth acquisition since joining the BW Forsyth Partners family of companies in 2012.Machine Solutions Inc. 08.28.20
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FDA Breakthrough Device Designation Granted for Fully Implanted Cochlear Implant
The Acclaim device offers the benefits of traditional partially implanted cochlear implants without the external components and associated disadvantages.Business Wire 08.28.20
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Mike on Medtech: Breakthrough Designation Program Update
Mike Drues and Sean Fenske revisit the breakthrough designation program and talk about the changes that have occurred since its inception.Sean Fenske, Editor in Chief 08.28.20
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R&D & Design | Software & IT
COVID-19 Marks a Need for Virtual Development Tech
Medical device developers can gain benefits from the use of MR/AR, but challenges need to be addressed first.Online Exclusives Dijam Panigrahi, Co-Founder and COO, Grid Raster Inc. 08.10.20
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Surgical
Olympus Buys Arc Medical Design
Underscores Olympus' commitment to expanding its offering in gastrointestinal therapeutic devices.PR Newswire 08.07.20
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Cardiovascular | Neurological
New Design Principle Could Prevent Brain Shunt Catheter Failure
Major challenge in hydrocephalus catheters—clogging—could be overcome by leveraging catheter geometry.Mindy Blodgett, Institute for Medical Engineering and Science, MIT 07.31.20
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Surgical
FDA Grants Breakthrough Device Designation for Ethicon’s Microwave Ablation Technology
Provides a minimally invasive option for soft tissue lesions.Ethicon 07.30.20
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R&D & Design
Design for Manufacturability Requirements
Planning for a Successful DFM Partnership
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R&D & Design
From the Experts: Best Practices to Ensure Device Success
Experts break down the issues device makers are faced with.Online Exclusives Jon Speer, Founder and VP of QA/RA at Greenlight Guru 07.27.20
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R&D & Design
‘COVID-19-Edition’ of Medical Device Competition Announces Finalists
Winners will receive grant awards of up to $50,000.Children's National 07.13.20
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R&D & Design
Catheter Ablation Technology and the Circular Economy
How device manufacturers can benefit from this different methodology.Online Exclusives Lars Thording, VP of Marketing & Public Affairs at Innovative Health LLC 07.09.20
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Cardiovascular
FDA Breakthrough Device Designation Granted for Thoraflex Hybrid Graft
The product combines a gelatin-sealed woven polyester graft with a Nitinol self-expanding stent graft.Terumo Aortic 06.25.20
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R&D & Design
Heraeus Collaboration Hub Begins Operations
Enables medical device customers and partners to work on-site with Heraeus Medical Components.Heraeus Medical Components 06.24.20
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An Open-Source Ventilator System Reference Design to Fight COVID-19
Renesas’ engineers have followed several open-source ventilator designs to come up with an easy to assemble three board ventilator plan.Business Wire 06.11.20
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How Are MPO’s Top 30 Addressing COVID-19?
J&J's Janssen moves the start of its Phase 1/2a vaccine clinical trial from September to the first half of July.Online Exclusives Sam Brusco, Associate Editor 06.09.20
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FDA Grants Breakthrough Device Designation to Vapotherm's Oxygen Assist Module
Vapotherm's OAM is a module for use with most versions of its Precision Flow systems.Business Wire 06.05.20
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R&D & Design | Surgical
Sparking Innovation as We Struggle to Find the New Normal
The goal is to find the best ideas to support orthopedic patients adjusting to additional pain and immobility while they wait for elective surgeries.Dawn A. Lissy, Founder & President, Empirical 06.04.20
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R&D & Design
Disposable Design: Consider All Interfaces
The disposable component is becoming more challenging as products get smaller and more complex.Will DeMore, Mechanical Engineer, Key Technologies Inc. 06.04.20
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Packaging & Sterilization
Six Key Design Features to Ensure Medical Device Packaging Meets ASTM D4169
Well-thought-out packaging is an oft-delayed but essential part of ensuring a medical device operates safely and effectively in the field.Nigel Syrotuck, Mechanical Engineering Team Lead, StarFish Medical 06.04.20
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R&D & Design
Human Factors Activities at a Safe Distance
How to keep medical device development on track during the COVID-19 pandemic.Online Exclusives Timothy Visich and Kate MacNamee, Program Managers, Senior Human Factors Engineers at Farm, a Flex company 06.03.20
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Digital Health | R&D & Design
The Four Steps of Design Acceleration
How to meet the needs of manufacturers, clinicians, healthcare workers, and patients in the ‘new normal.’Online Exclusives Ken Olewiler, Founder and Managing Director of Punchcut 06.01.20
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R&D & Design
6 Questions To Ask When Developing a Wearable Medical Device
How to design around skin—the unique substrate your device will adhere to.Online Exclusives Del R. Lawson, Ph.D., and Kris Godbey 05.28.20
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FDA Grants EUA to UMass' Simpler Ventilator Design
UMass Amherst physicist, global team advance practical device for COVID-19.University of Massachusetts Amherst 05.14.20
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R&D & Design
Medtech R&D Process Aided by Big Data, AI
Digital health allows researchers and engineers to incorporate data sets of user behaviors into their prototypes during the early phases of R&D.Online Exclusives Michael Barbella, Managing Editor 05.13.20
