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Importer And Distributor Repackaging And Relabeling In The EU: New Guidance Published

It is vital that importers and distributors in the EU who are repackaging and relabeling medical devices know their responsibilities under the new MDR and are aware that they could be moving into manufacturer territory. New guidance spells out the new rules.

Guidance Documents Manufacturing EU

EMA Consults On Proposed Framework For Patient Preference Studies

The EMA is inviting feedback on its plans to ratify, with some caveats, a new framework on how to use patient preferences as input in medical product decision-making. The framework was developed under the EU’s public-private Innovative Medicines Initiative.

Europe Regulation Medical Device

Delving Deeper Into How EU Rules For Legacy Device Apply

Guidance has been issued on exactly how the Medical Device Regulation requirements apply to ‘legacy’ and ‘old’ devices which remain on the market in compliance with the medical device directives.

Regulation EU Europe

CTA’s Standards For Digital Therapeutics Clears Up ‘Industry Confusion’

The Consumer Technology Association hopes its newly developed standard for digital therapeutics will clear up industry confusion and encourage the adoption of these treatments.

Digital Health Artificial Intelligence Consumer

FDA Panel Recommends Against Approval Of Integra Mesh For Breast Reconstruction

The data supporting SurgiMend PRS ABDM isn’t enough to fully prove safety and effectiveness for that indication, the US FDA’s General and Plastic Surgery Devices Advisory Committee says.

Advisory Committees FDA Regulation

Market Intel: Lessons Learned From COVID-19: A Global Perspective On Digital Health Transformation

Health leaders in Sweden, Norway, Australia, Canada and Taiwan predicted the universal impact of digital solutions during the pandemic and lessons learned that will impact future care.

Market Intelligence Coronavirus COVID-19 Digital Health

Device Week, 21 October 2021 – Post-Pandemic Perspectives; Good And Bad News For Medtronic

In this edition of Device Week, Medtech Insight’s Reed Miller discusses some important news from Medtronic and Marion Webb reviews the first of two feature articles on the impact of the pandemic on the medtech industry around the world.

Device Week Coronavirus COVID-19 Diversity & Inclusion

Device Week Podcast


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EN ISO 13485 and EN ISO 14971: Next Wave Of EU Standards Now Due ‘By December’

Listen to Medtech Insight podcasts for our perspectives on regulation, policy, quality, R&D and key commercial topics. >More Podcasts


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Policy & Regulation Explore this Topic

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UK To Up Transparency By ‘Auto Registering’ Trials

The UK Health Research Authority (HRA) has partnered with an international clinical trials registry to make it easier for sponsors and researchers to comply with the mandatory requirement of registering their studies in an established public database within a specific time frame.

Clinical Trials Compliance Regulation

Speaking Of Medtech, Ep. 2 – Breakthrough Medical Devices

In this episode of our new deep-dive podcast Speaking Of Medtech, former US FDA device center compliance chief Steve Silverman and Medtech Insight executive editor Shawn M. Schmitt talk about the agency’s Breakthrough Devices Program – what it is, how it operates, how device makers can take full advantage of the pathway, and more.

FDA Innovation Review Pathway

Latest From Policy & Regulation

Settlements Announced In Three “Electro-Acupuncture” False Claims Cases; Charges Filed Against Billing Consultant

Fraudsters have reportedly billed the government for the treatment, which uses electric impulses to replace the traditional needles of acupuncture.

Policy Enforcement

Hear! Hear! Industry Responds To FDA Proposal On OTC Hearing Aids

The FDA’s recent proposal to allow hearing aids to be sold over the counter without a prescription has mostly been met with approval. Many Americans, however, are unaware of the plan.

FDA OTC Devices

Not Sure If You’re Making Hearing Aids Or PSAPs? FDA’s New Draft Guidance Should Help

A guidance document proposed by the US agency on 20 October explains the difference between hearing aids, which are regulated as medical devices, and personal sound amplification products – or PSAPs – which aren’t.

Guidance Documents FDA

EU Has Now Designated 30 Notified Bodies For Medtech Products

Latest EU MDR notified body designation brings total in Italy to six, the same as Germany.

EU Europe

UK’s Ambitious Plan For Medtech Regulation Merits Attention

The MHRA’s efforts to give the UK a nimble, responsive, innovation-facing medtech regulatory system earnt high marks from Bristows’ Alex Denoon, who assessed the opportunity at hand during the MedTech Summit.

United Kingdom Regulation

No Prescription? No Problem: FDA Draft Rule Gives Green Light To OTC Hearing Aids

The US FDA’s proposed reg, released on 19 October, aims to get more hearing aids into the ears of those who need them by allowing the devices to be purchased over the counter.

OTC Devices Regulation

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

Rust Cause: Cook Medical Recalls Medical Needles Because They Might Be Rusty

The company recalled its Transseptal Needle and Transseptal Needle with Catheter on 18 October because there could be rust on the outside or inside of the product.

Recalls Safety

EU Has Now Designated 30 Notified Bodies For Medtech Products

Latest EU MDR notified body designation brings total in Italy to six, the same as Germany.

EU Europe

FDA Clarifies Software Link In Abbott COVID-19 Lab Test Recall

The recall is related to the software’s mixing parameters, which may cause false positives if test samples contaminate each other.

Recalls Safety

OUTLOOK 2021

Forward-looking features and special content, including Scrip 100, Medtech 100 and Generics Top 50 industry rankings

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Commercial Explore this Topic

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Execs On The Move: Promotions At Intuitive

Intuitive has appointed new chief financial, commercial and strategy and growth officers.

Executive Changes Commercial Companies

Latest From Commercial

Cardiovascular Catch-Up: TAVR Withstands Delta Virus So Far; Stereotaxis Robot Succeeds In Trial

The impact of the Delta variant of COVID-19 on procedure volumes remains a major concern for transcatheter valve makers, Abbott launches a new PFO closure device, and more highlights from the cardiovascular technology market in early October.

Cardiovascular Approvals

Inivata Continues Trials Of Its Liquid Biopsy Platform

The partnership with the Princess Margaret Cancer Center will support two studies of liquid biopsy testing for lung cancer.

In Vitro Diagnostics Cancer

Exec Chat: Abionic Is Accelerating Diagnostics To Save Lives

Abionic CEO Nicolas Durand explains how Abionic is filling unmet needs in diagnostics and the Swiss company’s plans for expansion.

Innovation In Vitro Diagnostics

Exec Chat: MeMed Improves Diagnostics To Combat Antimicrobial resistance

Kfir Oved, co-founder and CTO of MeMed, talked to Medtech Insight about diagnostic testing that can differentiate bacterial and viral infections to fight antimicrobial resistance.

C-Suite Speaks Innovation

Hologic Adds Vessel Sealing Tech By Acquiring Bolder Surgical For $160M

Colorado-based Bolder recently announced the global launch of the CoolSeal vessel sealing platform, which will complement Hologic’s obstetrical/gynecological surgery product line.

M & A Gynecology & Urology

Execs On The Move: A Relatively Quiet Week For Executive Appointments

Invent Medic Sweden has appointed a new chief executive officer and OncoCyte appointed a new chief operating officer.

Executive Changes Commercial

Clinical R&D Explore this Topic

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J&J Pushes Back Launch Of Ottava Robotic Platform By Two Years

The company originally expected the first-in-human trial of the soft-tissue robotic surgery system to begin in late 2022 and reach the market by 2023, but the company now expects those trials to begin in 2024.

Robotic Surgery Clinical Trials Approvals

Latest From Research & Development

Cardiovascular Catch-Up: TAVR Withstands Delta Virus So Far; Stereotaxis Robot Succeeds In Trial

The impact of the Delta variant of COVID-19 on procedure volumes remains a major concern for transcatheter valve makers, Abbott launches a new PFO closure device, and more highlights from the cardiovascular technology market in early October.

Cardiovascular Approvals

Exec Chat: Abionic Is Accelerating Diagnostics To Save Lives

Abionic CEO Nicolas Durand explains how Abionic is filling unmet needs in diagnostics and the Swiss company’s plans for expansion.

Innovation In Vitro Diagnostics

FDA Reminds Diagnostics Makers Of Rules On Research Using Human Specimens

Even research using leftover, deidentified specimens must be reviewed by an IRB, the US agency said in a letter to industry.

In Vitro Diagnostics Medical Device

Medtronic Pushes Completion Of Pivotal Renal Denervation Trial To Late 2022

The company announced that results from the pivotal SPYRAL HTN-ON MED trial of its Symplicity renal denervation system will not be available until the trial completes enrollment next year. The company previously expected to be able to present favorable interim results from the trial in November.

Clinical Trials Approvals

Dexcom Announces CGM Real-Time Data Now Available On Garmin Wearables, Bike Computers

Dexcom is making CGM data available through consumer devices starting with Garmin’s smartwatches and bicycle computers.

Diabetic Care Digital Health

Medtronic ‘Refreshes Brand,’ Announces New Environmental, Social, and Governance Targets

The company reported its progress in key environmental, social, and governance areas over the past year along with some new performance targets related to sustainability and inclusion. Medtronic also added a new “tagline” to its brand.

Sustainability Diversity & Inclusion
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