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Diagnostics
Breakthrough Device Designation Granted for Skin Cancer Diagnostic
Veriskin also secures funding from the National Cancer Institute for its TruScore device.Business Wire 07.28.21
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Electronics
Electronic Medical Device Design Considerations—A Medtech Makers Q&A
Ensuring the proper connections are made can be a greater challenge than device manufacturers may realize.
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Catheter and Medical Design Hires Two Industry Experts
Rich Abraham and Scott Olson will lead business development and customer relationships in the East Coast and Midwest markets.Catheter and Medical Design LLC 07.16.21
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R&D & Design
Medical Device Development: Three Tips for Success
Analyzing the design phase of the medical device development process.Online Exclusives Shrinidh Joshi, medtech consultant on Kolabtree 07.01.21
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FDA Breakthrough Device Designation Granted for Revita DMR
Study is underway to evaluate the effectiveness of Revita DMR in improving glucose control while reducing or eliminating the need for insulin.Business Wire 06.24.21
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The Makings of a Successful Medical Device Design:
10 Dimensions of Excellence
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Diagnostics
FDA Breakthrough Device Designation Granted for OCT Imaging System
Designation provides potential pathway to expedite adoption of transformative medical imaging technology combined with AI.Business Wire 06.09.21
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Digital Health
FDA Grants Breakthrough Device Designation to Woebot Health’s WB001
A digital therapeutic for the treatment of postpartum depression.Charles Sternberg, Assistant Editor 06.03.21
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R&D & Design
5 Steps to Minimize the Impact of Product Development Scope Creep
This article will cover signs of scope creep and a suggested method and approach to minimize that impact.Shaher Ahmad, Partner, Factor 7 Medical 06.02.21
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Packaging & Sterilization
Packaging Design Considerations to Ensure a Safe, Sterile Medical Device
Choosing the right packaging configuration for a medical device is critical to ensure safety and sterility to the end user.Britt Jones, Manager, Chemistry & Package Testing, WuXi AppTec Medical Device Testing 06.02.21
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Materials | R&D & Design
5 Things You Need to Know about Metals Traceability
McMaster-Carr discusses the importance of metal traceability in medical device design.
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Chemence Medical Receives FDA Approval for Exofin Fusion Redesign
Product line now features mesh that has curved ends.Michael Barbella, Managing Editor 05.25.21
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Chronic Disease
Avenda Health’s Male ‘Lumpectomy’ Receives Breakthrough Device Designation
The AI-based focal therapy system is designed to treat prostate cancer.Charles Sternberg, Assistant Editor 05.13.21
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R&D & Design
Overview of the Medical Device Design History File, Technical File, and Design Dossier
The FDA requires manufacturers to follow design control principles to ensure that specified design requirements are met.Online Exclusives David Butcher, Staff Writer, MasterControl 05.06.21
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Breakthrough Device Designation Granted to Tempus’ Afib ECG Analysis Platform
The platform was developed in collaboration with Geisinger.Michael Barbella, Managing Editor 05.03.21
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R&D & Design
Medical Device Design for Smaller and Smarter Medtech
Developers of medtech are asked to reduce the size of devices, and fortunately, can take advantage of newer tools that better enable them to do just that.Mark Crawford, Contributing Writer 05.03.21
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R&D & Design
User Evaluation in the Absence of User Data with Platform Devices
Accurate identification of the intended user population is not an option here.Finola Austin, Human Factors Engineering Manager, Owen Mumford 05.03.21
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Diagnostics | R&D & Design
5 Guidelines for Productizing an Optically Based Medical Device
Pitfalls most relevant to optical medical devices, but many are applicable to medical devices without optics.Online Exclusives Brian King, Principal Optical Systems Engineer, StarFish Medical 04.29.21
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R&D & Design
5 Ways Medical Device Prototyping Improves Manufacturing
Prototyping can help improve profits, reduce risks, and even save lives.Online Exclusives Emily Newton, Editor-in-Chief, Revolutionized 04.29.21
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Chronic Disease
Medtronic’s Emprint Ablation Catheter Kit Receives FDA Breakthrough Designation
Minimally invasive option has potential to provide long-term management of lung malignancies while protecting lung function.Charles Sternberg, Assistant Editor 04.28.21
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FDA Breakthrough Device Designation Granted for pdSTIM System
Product from Stimdia Medical is designed to facilitate weaning patients from mechanical ventilation.Michael Barbella, Managing Editor 04.21.21
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Contract Manufacturing | R&D & Design
Moving from Concept to Design—MPO Videobites
Mike Schultz of Spectrum Plastics Group speaks with MPO’s Sean Fenske about the Launch Pad Engineering Service the firm offers for medical device manufacturers.Videos Sean Fenske, Editor-in-Chief
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FDA Breakthrough Device Designation Granted to Machine Learning Diagnostic Method
Algorithm developed for earlier detection of gastrointestinal bleeding.Michael Barbella, Managing Editor 03.18.21
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Catheter and Medical Design Acquires VitalDyne Medical Inc.
Provides customers with greater speed, flexibility, and value.Charles Sternberg, Assistant Editor 03.16.21
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R&D & Design
Six Questions to Consider in Developing a Home Healthcare Device
These design decisions stem from questions relative to in-home use and 60601-1-11 compliance.Rachael Scott, Lead Electrical Engineer, Key Tech 03.03.21
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FDA Breakthrough Device Designation Awarded to BrainCool AB's Cooral System
The Cooral System was CE marked in June 2020 as an invasive medical device.Michael Barbella, Managing Editor 03.02.21
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Mike on Medtech: Update on FDA's STeP Designation
Mike Drues and Sean Fenske discuss the final guidance for the FDA’s STeP designation and who should use it.Sean Fenske, Editor-in-Chief 02.26.21
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Cardiovascular
FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump
Puzzle Medical Device's ModulHeart helps patients avoid open-heart surgery and reduces blood trauma.Michael Barbella, Managing Editor 02.25.21
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Contract Manufacturing | R&D & Design
SteriPack Acquires HS Design
Provides flexible and responsive design, development, and contract manufacturing solutions.Sam Brusco, Associate Editor 02.23.21
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Where Component Design Functionality and Cost Reduction Converge
Cold Formed Medical Devices vs. Traditional Manufacturing Techniques
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Qosina Offers Vast Selection of Critical Care Components for Respiratory Medical Device Design
Qosina offers countless off-the-shelf solutions for oxygen and respiratory medical device projects
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R&D & Design
Innovation Incubators: An R&D Roundtable
Eight experts discuss the myriad factors affecting the outsourced medtech research and development industry.Sam Brusco, Associate Editor 02.03.21
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R&D & Design
Pandemic-Level Playing Field: How COVID-19 Made Space for Progress
Pandemic restrictions may have diminished certain advantages large companies hold over small and mid-sized competitors.Dawn A. Lissy, President & Founder, Empirical 02.03.21
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Cardiovascular | Surgical
Twist on Heart Valve Design Boosts Blood Flow, Prevents Clots
UBC Okanagan research could transform the current gold standard for heart valves.Sam Brusco, Associate Editor 01.27.21
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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
