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Featured Stories

HHS Policy Move Means FDA Must Publish More Documentation To Support Rulemaking Decisions

To be more transparent and allow more public discourse, the HHS now requires all its agencies to publish documents it uses to rationalize proposed rules and demonstration projects.

Policy Regulation FDA

Market Brief: Tissue-Engineered Wound Care Market Expected To Reach $1.9Bn By 2024 Amid Rising Chronic Disease

The skin replacement market is led by three key players who have all been impacted by COVID-19, but the sector may see a quicker rebound than others as treatments cannot be deferred for a long time.

Wound Management Wound Healing & Tissue Repair Market Intelligence

APACMed 2020: Healthineers Evolves Therapy Remit And Makes All Asia An Equal Priority

Siemens Healthineers' product mix of diagnostics and imaging products meant it was in the middle of a very dynamic situation when COVID-19 struck.

Asia Pacific Medical Device Commercial

‘Ready For Day 1’ – UK MHRA’s Statement Of Intent For Post-Brexit Medtech Regulatory System

The MHRA has been working all hours to ensure the standalone medtech UKCA mark works operationally and procedurally in the UK as of 1 January 2021.

United Kingdom Regulation Medical Device

Spotlight On R&D

COVID-19: Could Lateral Flow Test Using Glycan Recognition Be A Rapid Testing Breakthrough?

UK start up Iceni Diagnostics has secured funding to develop its test for the live, intact SARS-CoV-2 virus and the UK government is evaluating a lateral flow device based on the technology for testing saliva samples as part of efforts to step up rapid testing in the country.

Coronavirus COVID-19 Research & Development

ASTM Developing Standard To Tackle Dried Blood On Steel Devices

ASTM International is proposing a new standard that will provide a cleaning agent formula for removing dried blood from stainless steel medical devices.

International Standards Safety

Execs On The Move: New CEO For Humacyte; Internal Moves At Trinity Biotech, CVRx, Oventus Medical And Cancer Genetics

Trinity Biotech's new CFO is an internal move; Humacyte replaces CEO; chief strategy officer role for former CVRx CFO; and more.

Appointments Commercial Medical Device

QUOTED. 30 November 2020. David Hoffmeister.

A recent Department of Health and Human Services proposal to review regulations every 10 years may mean good things for the device industry, said David Hoffmeister, partner, Wilson Sonsini Goodrich & Rosati.

Quoted FDA Medical Device

Infographic: COPD Market To Reach $23.7Bn By 2022

The market for devices to treat chronic obstructive pulmonary disease (COPD) is set to grow by 5.0% annually i...

Device Week Podcast



Discussed in this episode:


Boston Scientific Gives Up On Lotus Edge TAVR

The company is recalling all unused Lotus Edge inventory and will stop developing the Lotus platform while shifting resources to support its Acurate n...

Business Strategies Cardiovascular






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Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Post-Brexit MHRA Will Embrace Medtech ‘Innovation Pull’ In The UK

The national regulator is to undergo a review in 2021 as the UK begins life as a former EU member, presenting opportunities to be seized.

United Kingdom Brexit Regulation

10 Predictions On How Health Policy Could Change Under A Biden Presidency

Health policy changes that President-elect Joe Biden will likely make during his four-year term include Medicaid expansion and a greater reliance on medical science, among others, experts say.

Policy Leadership Telehealth

Latest From Policy & Regulation

COVID-19 Serology Templates: FDA Updates Sponsor Template, Adds Home Test Document

The templates from the US agency provide guidance to manufacturers developing antibody tests for clinical or at-home use.

Coronavirus COVID-19 In Vitro Diagnostics

COVID-19: New Emergency Guidance From AAMI Targets Remote-Controlled Devices

Consensus report CR511 from the Association for the Advancement of Medical Instrumentation highlights common system elements for engineers, and outlines safety and risk-control measures that manufacturers and caregivers should consider.

Guidance Documents Coronavirus COVID-19

Hologic Aptima Assay Cleared For HIV Detection

Already cleared to monitor the viral load in HIV-positive individuals, the test has now been approved for initial diagnosis as well.

Approvals FDA

Experts: HHS Review Proposal May Free Industry From Regulatory Red Tape

Attorneys tell Medtech Insight a recent proposal to review regulations every 10 years could lift some burdens from the medical device industry, but warned that the full effects may not be seen for some time.

Regulation FDA

Warning Letter Roundup & Recap – 24 November 2020

No device-related warning letters were released by the US FDA the week of 24 November.

Device Warning Letters FDA

CMS Removes Some Stark Law ‘Bureaucratic Barriers’ In Final Rule

The Stark Law ban on self-referrals wouldn’t apply to some physician owners of advanced imaging facilities under a CMS final rule.

Policy Reimbursement

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Recent eMDR Change By FDA Asks Adverse Event Reporters About Third-Party Servicers

The addition of the question “Was this device serviced by a third party servicer?” to adverse event reports filed through the US FDA’s electronic Medical Device Reporting system could prove helpful for the agency and device makers, experts tell Medtech Insight. Industry has long complained about poor work performed by servicers – and loudly groused that they’re not regulated.

FDA Safety

Notified Body Pain Points: The Challenges And Obstacles Industry Needs To Avoid

Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, and can the sector manage the new regulatory requirements successfully?

Europe EU

Q3 Recalls Snapshot: It’s Good News For Industry And Patients As Recall Events, Recalled Units Fall

Medical device manufacturers initiated fewer recalls in the third quarter of 2020. Check out our Q3 recalls infographic.

Recalls FDA

Commercial Explore this Topic

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Advancing The Precision Mission At RSNA 2020

The RSNA is the next global medtech exhibition and conference event to be run under a virtual format this fall.

Commercial Diagnostic Imaging Artificial Intelligence

Latest From Commercial

GT Medical Technologies Raises $16M To Expand Brain Tumor Therapy

The company will use the proceeds to fund clinical trials, expand commercialization of its targeted radiation therapy, and file for CE marking in Europe.

Cancer Financing

Revitalized Conmed Pushes The Increments In Ortho And Says ‘Innovation Always Wins’

COVID-19 put a dampener on Conmed’s 50th anniversary of operations, but CFO Todd Garner says the company is poised to resume its growth strategy, post-pandemic.

Commercial Strategy

Johnson & Johnson Unveils Details On Ottava Soft-Tissue Robot, Chasing Intuitive, Medtronic

J&J said its Ottava robotic platform has six robotic arms, “zero footprint,” and can be used for various procedures.

Robotic Surgery Surgical Procedures

Device Week, 19 November 2020 – Glooko Exec Chat; Boston Scientific Kills Lotus TAVR

In this week’s podcast, Marion Webb reviews her interview with Glooko CEO Russ Johannesson and Reed Miller explains how Boston Scientific is restructuring its transcatheter aortic valve business.

Device Week Business Strategies

Pear Therapeutics Launches Digital Insomnia Telehealth App

The pandemic has led to a rise in sleep problems. Somryst seeks to address chronic insomnia by training the body and brain to fall asleep faster and stay asleep longer.

Digital Health Launches

Abbott Becomes First Anchor Sponsor For American Diabetes Association Health Equity Now Initiative

Abbott will commit $5m to support the ADA’s efforts to bring diabetes technologies and education to underserved diabetes populations.

Diabetic Care Coronavirus COVID-19

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

AMS Acquires Raleigh Adhesive Coatings For £22M To Expand Wound-Care Biz

Advanced Medical Solutions said it will buy Raleigh Adhesive Coatings for £22m in cash to bring silicone coating technology in-house. 

Wound Healing & Tissue Repair M & A Financing

Latest From Research & Development

COVID-19: Could Lateral Flow Test Using Glycan Recognition Be A Rapid Testing Breakthrough?

UK start up Iceni Diagnostics has secured funding to develop its test for the live, intact SARS-CoV-2 virus and the UK government is evaluating a lateral flow device based on the technology for testing saliva samples as part of efforts to step up rapid testing in the country.

Coronavirus COVID-19 Research & Development

GT Medical Technologies Raises $16M To Expand Brain Tumor Therapy

The company will use the proceeds to fund clinical trials, expand commercialization of its targeted radiation therapy, and file for CE marking in Europe.

Cancer Financing

Johnson & Johnson Unveils Details On Ottava Soft-Tissue Robot, Chasing Intuitive, Medtronic

J&J said its Ottava robotic platform has six robotic arms, “zero footprint,” and can be used for various procedures.

Robotic Surgery Surgical Procedures

US FDA Adds 14 New Regulatory Tools To Help It Review Medical Devices

The tools include new laboratory methods, and computational models and simulations give the agency more capabilities to test and validate data in premarket submissions.

Regulation FDA

Three Studies Support Medtronic’s Cryoablation Systems As ‘First Line’ AFib Treatment

Data from the EARLY AF First, Cryo-FIRST and STOP AF trials show cryoablation is a better option than drugs for patients with symptomatic atrial fibrillation.

Clinical Trials Research & Development

Medical Imaging Disruptor Nano-X Pushes On With Launch Plans In Face Of Shareholder Lawsuit

Nano-X Imaging is on a mission to disrupt the market for X-ray imaging equipment by offering a low-cost medical imaging service to untapped markets through a network of equipment dotted around the world. However, some shareholders are claiming the company mislead investors.

Research & Development Diagnostic Imaging
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