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Ava Begins Evaluation of its Fertility Tracking Sensor Bracelet in COVID-19 Detection
Pilot study data shows Ava's algorithm accurately detected 71 percent of COVID-19 positive infections two days before symptom onset.Michael Barbella, Managing Editor 04.27.21
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Software & IT
Three Ways to Fast-Track the Total Product Lifecycle
Here are three ways leaders including Alcon, Baxter Healthcare, Boston Scientific, Epredia, and Illumina are driving innovation in medtech.Seth Goldenberg, Ph.D., Vice President, MedTech, Veeva Systems 03.04.21
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FDA Clears Ava Fertility Tracking Wearable Device
The wearable is clinically proven as effective as LH tests in predicting ovulation—and with more fertile days detected.Michael Barbella, Managing Editor 02.26.21
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Summit Medical, Practico Solutions Develop Tracking Module for Robotic Instrument Reprocessing
Medical device manufacturer responds to recent FDA guidance update to ensure hospital compliance.Business Wire 10.22.20
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Surgical
FDA OKs Philips, B. Braun's Onvision Needle Tip Tracking
Onvision gives anesthesiologists the confidence to accurately position the needle tip inside the body for peripheral nerve blocks.GlobeNewswire 08.26.20
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Rising to the Challenge: Six Innovators Win Fast-Track Support to Market
These six winning submissions reflect a keen awareness of patient needs during the unique and surprising circumstances of the COVID-19 pandemic.Dawn A. Lissy, Founder & President, Empirical 07.21.20
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Fitness Tracker Company Manufacturing Face Masks to Fight Pandemic
The masks will be distributed to healthcare workers, law enforcement, food handlers, and the general public.PR Newswire 06.10.20
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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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Patient Monitoring
Wearable Sensor Tracks Vitamin C Levels in Sweat
Non-Invasive tech could support dietary adherence, detect nutritional deficiencies.Alison Caldwell, Bigelow Science Communication Fellow, UC San Diego Jacobs School of Engineering 05.19.20
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Keeping Compliance on Track Through Testing
The beginning of 2020 has left the industry strained and delayed implementation of the Medical Device Regulation by one year.Sandi Schaible, WuXi Medical Device Testing 05.01.20
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R&D & Design
COVID-19 Pandemic Brings Fast-Track Innovation to Forefront
A look at the ways in which The Innovation Institute and its community is introducing new technologies for the effort against the virus.Online Exclusives Joe Randolph, President and CEO, The Innovation Institute 04.28.20
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Electronics | Patient Monitoring
Sensors Woven into a Shirt Can Monitor Vital Signs
Comfortable, form-fitting garments could be used to remotely track patients' health.Massachusetts Institute of Technology 04.24.20
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Diagnostics
Siemens Healthineers to Expand SARS-CoV-2 Testing
With a demonstrated sensitivity and specificity of more than 99 percent, the test is expected to exceed the stringent FDA quality guidelines.Siemens Healthineers 04.23.20
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Endonovo Therapeutics Introduces Support of SofPulse With New Patient Brace
The brace allows site-specific application and promotes ease of use for patients and medical professionals when using the SofPulse device.Globe Newswire 04.23.20
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Itamar Medical to Evaluate Impact of CPAP Therapy on Patients with COVID-19
The clinical trial will assess the efficacy of CPAP in COVID-19 confirmed or suspected patients.Globe Newswire 04.22.20
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Integrity Applications Closes $15 Million Private Placement
Shares were sold for 40 cents each.Globe Newswire 04.22.20
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Patient Monitoring | Surgical
Brainlab's ExacTrac Dynamic Patient Positioning, Monitoring Gains CE Mark
New 4D thermal surface tracking combined with flagship X-ray technology increases versatility.Business Wire 04.21.20
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Diagnostics
FDA Update: COVID-19 Antibody Test Validation and Education
Results from these tests can help identify who has been infected and developed antibodies.U.S. Food and Drug Administration 04.20.20
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Diagnostics
Gold Standard Diagnostics Releases Three COVID-19 Antibody Tests
The IgA, IgG, and IgM assays are formatted for optimal functionality in diagnostic laboratories.Business Wire 04.17.20
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LocatorX Launches National Medical Device Registry to Track Ventilators
Free registry enables any hospital to log and track ventilators with a simple scan.Globe Newswire 04.17.20
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Diagnostics
CRISPR-Based Test Kit Can Diagnose COVID-19 in Under an Hour
DETECTR test can be performed in virtually any lab, using off-the-shelf reagents and common equipment.Jason Alvarez, University of California - San Francisco 04.16.20
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Non-Invasive Microcirculatory Device Could Help COVID-19 Patients
Product provides non-invasive, transdermal microcirculation to improve overall oxygen-rich blood flow and treat underlying medical conditions.Circularity Healthcare LLC 04.14.20
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3M Files Lawsuit Alleging N95 Price Gouging in NYC
Defendant offered to sell $45m in N95 respirators to NYC officials at prices 500-600 percent over 3M list price.Business Wire 04.13.20
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Fitness Tracker Company Manufacturing N95 Equivalent Face Masks
The masks will be distributed to health care workers, law enforcement, food handlers, and the general public.PR Newswire 04.13.20
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Circadia Health Commits $3 Million in Respiratory Monitors to Combat COVID-19
Effort is in response to FDA’s latest guidance to expand the availability and capability of non-invasive remote respiratory monitoring devices.Globe Newswire 04.02.20
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Diagnostics
Siemens Healthineers Releases Test Kit for Coronavirus COVID-19
Test kit will help detect SARS-CoV-2, the cause of COVID-19; company is pursuing EUAs from WHO and FDA for clinical use.Siemens Healthineers 04.02.20
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Software & IT
Validating Your QMS the ‘EZ Way’
Securing approval for an eQMS solution is only the beginning; ensuring it’s properly installed and set up is arguably more significant.James Shore and Roxana Rosales 04.01.20
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Digital Health
Digital Defenders: COVID-19 Creates a Spotlight on Digital Health Tools
Digital health tools like telemedicine, AI algorithms, and connectivity are playing an increasingly important role in helping prevent and manage disease.Michael Barbella, Managing Editor 04.01.20
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R&D & Design
Why Outsourcing Is in: Piecing Out Projects Makes Sense
Getting outside help is a trend both large and small medical device companies are following as outsourcing engineering services continues to gain traction.Dawn A. Lissy, President & Founder, Empirical 04.01.20
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R&D & Design
Top 10 Considerations for Medtech Inventors
If you or your employer is interested in protecting an invention, then filing a patent application may be the way to go.Ryan Connell and Doug Portnow, Schwegman Lundberg & Woessner 04.01.20
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Diagnostics
FDA OKs Sectra's Digital Pathology Module
Available for primary diagnostics and remote reading in the U.S.PR Newswire 04.01.20
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Former Boston Scientific Marketing Director Joins CorWave Board
New board member also worked for Medtronic and Avedro.Business Wire 04.01.20
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Trump Signs $2 Trillion Coronavirus Stimulus Package
Legislation requires the strategic national stockpile to include certain medical devices necessary for diagnosing and treating COVID-19.Staff and Wire reports 03.27.20
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Patient Monitoring
Medtronic Launches New Solutions to Monitor COVID-19
Helps assess, monitor, and triage support for patients concerned about COVID-19 and respiratory symptoms.GlobeNewswire 03.27.20
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Patient Monitoring
Butterfly Network Welcomes New CEO
Butterfly iQ point-of-care ultrasound is "proving to be a powerful weapon" against COVID-19 according to new CEO Laurent Faracci.PR Newswire 03.26.20
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GenMark Diagnostics Promotes COO to Interim President and CEO
Search is underway for a permanent replacement to retiring chief executive.Globe Newswire 03.26.20
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Diagnostics
World's First Ultrasound Biosensor Created in Australia
Potential cheap and portable disease sensor on horizon.Monash University 03.25.20
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Former Boston Scientific Exec Named DYSIS Medical Board Chairman
New leader also served on the boards of Clinical Innovations and Therakos.Business Wire 03.25.20
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Former Visiogen Chief Executive Tapped to Lead PROCEPT BioRobotics
New CEO also held the top position at Avedro, which was acquired by Glaukos in November 2019.Business Wire 03.19.20
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R&D & Design
Pediatric Medical Device Pitch Competition Announces 30 Semi-Finalists
Thirty innovators will compete on March 23, 2020 in a virtual showcase.National Capital Consortium of Pediatric Device Innovators 03.19.20
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4 Medical Manufacturing Trends Driving Growth in 2020
Medical device manufacturing is poised for 5.6 percent growth each year between 2017 and 2023.Online Exclusives Megan Ray Nichols, Science Writer; Editor, Schooled By Science 03.17.20
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Surmodics Names New Vice President of Clinical Affairs
Former Edwards Lifesciences executive has more than 20 years of medical affairs, medtech, and healthcare experience.Business Wire 03.13.20
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R&D & Design
Four Considerations for Developers of Next-Generation Combination Products
Bringing together real-time monitoring, telemedicine, AI, interventions, and pharmaceuticals into a single device produces a number of potential pitfalls.Mark Goodman and Barry Thompson, Baker & McKenzie LLP 03.04.20
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Software & IT
Realizing Production Efficiency Through ERP Solutions
Medical product outsourcers share insights and best practices through a survey of manufacturers that’s centered around their outlook for 2020.Louis Columbus, Principal, IQMS/DelmiaWorks 03.04.20
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Optimizing Medtech Founder Value
Would optimizing valuation at seed and A rounds minimize founder dilution for better outcomes?Scott Phillips, CEO, StarFish Medical 03.04.20
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Contract Manufacturing
The Seychelles—A Solution for Niche Production
Geographic location, free trade agreements, and an educated workforce make the location an excellent fit for the right manufacturer.Jude Shroff, Managing Director, Chelle Medical Ltd. 03.04.20
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Software & IT
Expanding Quality Beyond the Four Walls of Your Organization
As suppliers can impact product quality, device manufacturers must oversee them as though they were an extension of the company and not an outside entity.Seth Goldenberg, Ph.D., and Carl Ning, Veeva Systems 03.04.20
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R&D & Design
Lessons Learned in Developing an Award-Winning Healthcare Product
Finding the right design partner helped ensure the proper pieces fell into place.Online Exclusives Brandy George, Content Strategist, Zen Media 03.03.20
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Patient Monitoring
Researchers Develop Algorithm to Track Epidemiology of Sepsis
Allows for the collection of more accurate data about outcomes and incidence of the condition over time.Children's Hospital of Philadelphia 03.02.20
