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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.
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.
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.
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.
Spotlight On Recalls & Safety
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.
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.
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.
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.
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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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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
OUTLOOK 2021
Forward-looking features and special content, including Scrip 100, Medtech 100 and Generics Top 50 industry rankings
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Execs On The Move: Promotions At Intuitive
Intuitive has appointed new chief financial, commercial and strategy and growth officers.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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