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FDA Advisory Panel Debates Science On Human Adverse Biological Reactions To Metal-Containing Devices

US FDA scientists and immunological experts discussed the latest science regarding patients’ biological reactions to metal implants and mercury in dental amalgam at a 13-14 November agency advisory committee meeting. The get-together was held to determine what additional actions the FDA can take to make sure certain patients are protected from immunological risks of the implants. The panel ultimately backed a transition away from mercury amalgam dental fillings and pushed for more research into risks associated with metal implants.

Safety FDA Advisory Committees

FDA Expands Indication For Axonics’ Incontinence System; Medtronic Claims Patent Infringement

The US FDA approved Axonics’ r-SNM sacral neuromodulation system for treating overactive bladder and urinary retention on 14 November. The agency approved the same device for treating chronic fecal incontinence on 9 September. Axonics expects r-SNM to rival Medtronic's InterStim II non-rechargeable sacral neuromodulation system, but Medtronic claims the r-SNM technology infringes on Medtronic’s intellectual property.

Approvals Legal Issues Intellectual Property

Process Validation Can Be Problematic For Device-Makers. Here’s Why – And What Companies Can Do About It

Medical device manufacturers often stumble when conducting process validation activities. In this Q&A, former US FDA investigations branch director Ricki Chase explains what those hurdles are and offers tips to firms to make sure they’re on the road to compliance.

Quality Compliance Regulation

Device Week, 14 November 2019 – Medtech Leaders Look To The Future At XMed 2019; Abbott Names New CEO

In this week's podcast, Medtech Insight managing editor Marion Webb summarizes her recent interviews with Ted Tanner, CTO of IBM Watson Health, and Catherine Mohr, president of the Intuitive Foundation, during the Exponential Medicine conference in San Diego. And deputy editor Reed Miller discusses the appointment of Robert Ford as the new CEO of Abbott Laboratories, the latest in a recent series of high-profile CEO appointments in medtech.

Device Week Artificial Intelligence Digital Health

Spotlight On Exec Chats

Exec Chat: XMed2019: How IBM Watson Health's CTO Uses Blockchain To Eliminate 'Friction Points' In Health Care

Ted Tanner, the new chief technology officer and chief architect of IBM Watson Health, recently sat down with Medtech Insight to discuss his plans for the company. In 2020, IBM will start testing the first use cases of its blockchain-based data information exchange network, a partnership with several health-care organizations, aimed to reduce administrative errors and save costs. Tanner refers to blockchain as an "enablement platform" that augments computing power.

Exec Chat Artificial Intelligence

QUOTED. 18 November 2019. Raymond Cohen.

Medtech giant Medtronic filed a patent infringement suit against Axonics, alleging Axonics' sacral neuromodulation technology infringes four of Medtronic's patents for implantable electrical stimulation lead fixation methods and transcutaneous inductive charging for implantable medical devices. See what Axonics CEO, Raymond Cohen, said about it here.

Quoted Approvals Legal Issues

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Medtech IT: How To Stay Ahead As Technology Accelerates

Outdated medtech IT solutions are stopping people from efficiently performing their jobs, a survey has found. Read this whitepaper to view more survey results and discusses how tech is changing Medtech.

Read the Whitepaper

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Will UK's Own Registration Plans Be Affected By Two-Year Delay To Eudamed Database?

With the UK still in political turmoil and due a general election on December 12, the future of Brexit is still uncertain. But if the UK exits the EU on 31 January, will the two-year delay in Eudamed be of less significance to the country in terms of registering medical devices, or is it more complicated than that?

EU Europe Policy

A Softer, Gentler FDA Inspectorate? It’s Possible With QSR/ISO 13485 Harmonization, Auditing Expert Says

Let’s be blunt: Device-makers aren’t particularly fond of facility inspections by the US FDA. From audits that can sometimes drag on for weeks to nightmarish inspections well-documented by industry experts, there’s no shortage of tales of investigators that were difficult to handle. But the agency’s ongoing rewrite of its Quality System Regulation to harmonize it with international standard ISO 13485 could “soften FDA’s inspectorate,” NSF International’s Brian Ludovico says. Also: How might the FDA’s Quality System Inspection Technique (QSIT) change, post-harmonization?

FDA Enforcement Compliance

FDA Issues Final Export Certificate Guidance, Explains What To Do If Your Firm Is Turned Down For One

An 8-page final guidance from the US agency lays bare reasons why it would deny an export certificate to a company. It also explains how a firm can appeal if it is turned down for a certificate. The guidance was developed because the FDA Reauthorization Act of 2017 – FDARA – required the agency to provide a rationale when it turns down a request for a Certificate to Foreign Government (CFG), including listing any specific grounds for a finding of noncompliance.

Guidance Documents Compliance

Senators Question FDA’s Proposed Progressive Approval Pathway For Devices

US Democratic Sens. Elizabeth Warren of Massachusetts and Patty Murray of Washington State recently sent a letter to FDA officials Brett Giroir and Jeff Shuren that raises doubts about a planned bill calling for a progressive approval pathway for medical devices.

Policy Regulation

FDA Will Have To Scrape By On Continuing Resolution Funding Through December, Legislative Experts Predict

While a government agency shutdown due to lack of agreement between Congress and the Trump administration over funding for the US Food and Drug Administration and other federal agencies seems less likely this year than last, the FDA will still have carry out its 2020 mission in the short term on 2019 continuing resolution funding – probably through December – legislative experts say.

Policy FDA

Warning Letter Roundup & Recap – 12 November 2019

No device-related warning letters were released by the US FDA the week of 12 November.

Device Warning Letters FDA

How The Rest Of The World Is Reeling From The EU's Regulatory Upheaval

Medtech consultant Arthur Brandwood explains why the EU’s medtech regulations are sending shockwaves through so many other countries, and why CE marking may be unlikely to return to its previous position as the preeminent international certification.

Europe EU

International Regulators Update Advice On Clinical Investigation, Evaluation And Evidence

Three global guidances dating back 10 years or more have been updated by the International Medical Device Regulators Forum (IMDRF). 

Clinical Trials Post Market Regulation & Studies

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

FDA Issues Final Export Certificate Guidance, Explains What To Do If Your Firm Is Turned Down For One

An 8-page final guidance from the US agency lays bare reasons why it would deny an export certificate to a company. It also explains how a firm can appeal if it is turned down for a certificate. The guidance was developed because the FDA Reauthorization Act of 2017 – FDARA – required the agency to provide a rationale when it turns down a request for a Certificate to Foreign Government (CFG), including listing any specific grounds for a finding of noncompliance.

Guidance Documents Compliance

Software Issue Brings Recall Of Zimmer ROSA

Zimmer Biomet has issued a recall on its ROSA Brain 3.0 software platform due to a software issue that could cause patient injury.

Recalls Safety

FDA’s Case For Quality Head Explains The Agency’s 2020 Maturity Model Pilot For Naughty Manufacturers

Cisco Vicenty tells how the US agency will structure its pilot program for device-makers with less-than-stellar compliance histories that want to use the CMMI maturity model framework to improve the quality and maturity of their manufacturing organizations – and clean up their compliance problems along the way. The FDA – which is partnering with the Medical Device Innovation Consortium (MDIC) and Pittsburgh’s CMMI Institute on the voluntary pilot – will offer the opportunity to 10 firms “that have had a negative inspection outcome, a warning letter, or possibly other regulatory action,” Vicenty explains to Medtech Insight. The pilot launches next year.

FDA Quality

Commercial Explore this Topic

Set Alert for Commercial

Medtech Veteran Robert Ford Will Take Over As Abbott CEO From Miles White

Abbott’s current COO Robert Ford will become the company’s new CEO on 31 March, 2020. Miles White is stepping down after 21 years leading the diversified health-care products company.

Appointments Commercial Companies

Nypro Experts: Adaptability And Agility Are More Critical Than Ever In Medtech

Nypro, a Jabil Company, offers design, engineering, supply chain and manufacturing services for the medical device, diagnostics, pharmaceutical and consumer health markets. In a contributed analysis, Jabil/Nypro's Joe McBeth, Erich Stein, Brad Womble and Doug Bond suggest the medical device industry has been relatively slow to adopt connected technologies, and must be ready to adapt more quickly in the future.

Analysis Business Strategies

QUOTED. 14 November 2019. William Osborn.

Abbott's CEO Miles White will step down at the end of March 2020 after 21 years on the job. Robert Ford, Abbott's president and COO, will succeed White as Abbott's CEO. See what William Osborn, chair of Abbott's board of directors' nominations and governance committee, said about it here.

Quoted Appointments

Execs On The Move: Management Changes In Marketing And Strategy At OmniGuide Holdings

Energy surgical tools developer OmniGuide Holdings welcomes a new VP of global marketing to manage worldwide marketing activities and a managing director for its OmniGuide Surgical Strategic Business Unit to guide technology innovation strategy.

Appointments Commercial

QUOTED. 13 November 2019. Ted Tanner.

Ted Tanner, CTO of IBM Watson Health, recently sat down with Medtech Insight to talk about his plans for developing a blockchain-based data information exchange network in partnership with health organizations to create 'frictionless' computing. See what Tanner said about it here.

Quoted Digital Health

Exec Chat: XMed2019: How IBM Watson Health's CTO Uses Blockchain To Eliminate 'Friction Points' In Health Care

Ted Tanner, the new chief technology officer and chief architect of IBM Watson Health, recently sat down with Medtech Insight to discuss his plans for the company. In 2020, IBM will start testing the first use cases of its blockchain-based data information exchange network, a partnership with several health-care organizations, aimed to reduce administrative errors and save costs. Tanner refers to blockchain as an "enablement platform" that augments computing power.

Exec Chat Artificial Intelligence

QUOTED. 12 November 2019. Catherine Mohr.

Catherine Mohr, president of the Intuitive Foundation, recently sat down with Medtech Insight to talk about her plans for the foundation including building a global, data-based network to train future surgeons who will be caring for millions of new patients in Asia and Africa. See what Mohr said about it here.

Quoted Artificial Intelligence

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Medtronic’s Micra Transcatheter Pacemaker Improves Cardiac Function In MARVEL 2

New clinical trial results show accelerometer-based atrial sensing with an automated, enhanced algorithm delivered by Medtronic’s leadless ventricular pacemaker can significantly improve atrioventricular synchrony in patients with sinus rhythm and atrioventricular block.

Clinical Trials Research & Development Cardiovascular

AHA 2019: Cardiawave Sees Positive Early Results For Non-Invasive 'Alternative' to TAVR

The French start-up claims first-in-man success for heart valve “softening” treatment and plans further trials for an EU launch.

Clinical Trials Innovation

QUOTED. 15 November 2019. Krishna Rocha-Singh.

On-going scrutiny has not explained an apparent link between paclitaxel-coated cardiac devices and an increased mortality rate, speakers said at the Vascular Interventional Advances (VIVA) 2019 conference in Las Vegas. See what Krishna Rocha-Singh, a VIVA board member, said about it here.

Quoted Research & Development

VIVA 2019: New Paclitaxel Data Shows Consistent Mortality Signal, No Clear Cause

Research investigating outcomes in patients treated with paclitaxel-coated devices demonstrated a consistent if modest mortality signal when compared to bare-metal stents. However, the signal was not seen in real-world data, and some researchers question whether the signal might stem from problems in the original trials. 

Research & Development Safety

VIVA 2019: Penumbra’s Indigo Effectively Treats PE In Pivotal Trial

Results of the EXTRACT PE trial, presented at the Vascular Interventional Advances Annual Meeting in Las Vegas, will support an application to the US FDA for Penumbra’s Indigo system for aspiration mechanical thrombectomy in patients with acute pulmonary embolism.

Clinical Trials Research & Development

QUOTED. 11 November 2019. Thomas Zeller.

Thomas Zeller of Germany’s Universitäts-Herzzentrum Freiburg-Bad Krozingen presented study data at the VIVA 2019 conference that showed peripheral artery disease (PAD) patients treated with paclitaxel-coated balloons for four years found good results – even in more complex cases. See what Zeller said here.

Quoted Cardiovascular

R&D Roundup, October 2019: TCT Brings More Transcatheter Valve Results, New Product Launches, Reassuring Data On Paclitaxel Risk

An overview of October’s ten most-read Medtech Insight articles on topics related to research and development of new medical technology.

Research & Development Innovation
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