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Medtech Insight

Inside Toyota's 'Cult' Car-Makers Quality VP Tells Device-Makers How To Adopt 4-Pronged Quality Strategy

By Shawn M. Schmitt 14 Nov 2022

Toyota Motor North America's Kristen Tabar told a roomful of medical device quality and regulatory professionals at a Case for Quality forum that they can infuse quality concepts into every nook and cranny of their firms by adopting the car-maker's quality strategy of reflection, education, celebration and planning. "I don’t want to make it sound like it’s sort of cult-y, but it’s kind of cult-y," Tabar quipped.

Medtech Insight

FDA, Industry To Miss MDUFA V Congressional Deadline; Insiders At Odds Over Future Of Deal

By Ferdous Al-Faruque 14 Jan 2022

The US agency and the medtech industry still have significant disagreements, which means they will miss a 15 January deadline to send the MDUFA V user-fee deal to Congress. Insiders disagree, however, on how severe those disagreements are and when a deal can be reached.

Medtech Insight

Execs On The Move: Acarix And Paige Appoint New CEOs

14 Jan 2022

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Paige, an AI-for-digital-pathology company, and Acarix AB, developers of an acoustic cardiac diagnostic both have new chiefs.

Medtech Insight

JPM 2022: Abiomed, Penumbra, Renalityx

By Reed Miller 13 Jan 2022

The annual J.P. Morgan Healthcare Conference includes presentations from major medtech companies describing their experience in 2021 and expectations for 2022 as they continue to cope with the impact of the Omicron surge. Here are some of the highlights from the presentations on the fourth day of the meeting.

Medtech Insight

US FDA-Sponsored Cybersecurity Threat Modeling Playbook Tries To Make It Simple

By Ferdous Al-Faruque 30 Nov 2021

The MITRE corporation and MDIC have produced a manual on how to use cybersecurity threat modeling to make safer medical devices. The document asks four basic questions and provides helpful examples.

Medtech Insight

Exec Chat: CMR Surgical Prepares For Intensifying Competition In RAS

By Barnaby Pickering 30 Nov 2021

In an interview with Medtech Insight, Per Vegard Nerserth, CEO of CMR Surgical, discusses how the company adapted to the pandemic, its future plans, and how the competition for market dominance is shaping up.

Medtech Insight

Leading Medtech CEOs Say Health Equity, Environmental Work Will Outlast Pandemic

By Marion Webb 02 Nov 2021

The medtech sector’s drive to create a fairer health care system and a greener world will go on after the COVID pandemic, which has brought such issues into sharp relief. CEOs at leading companies discuss environmental, social and governance imperatives for their companies and the larger industry.

Medtech Insight

Former US FDA Commish Califf Endorses ‘Tortoise’ Approach To Clinical Trials

By Brenda Sandburg 02 Nov 2021

The once and likely future FDA commissioner emphasized the value of randomized controlled trials, the fact that not all trials are good for people, and how decentralization and digitization are leaving people behind during a panel discussion.

Medtech Insight

Digital Health Roundup, August/September 2021: Record Digital Health Funding Q1-3 Of $21.3Bn, AAOS Highlights, Regulatory Updates

By Marion Webb 12 Oct 2021

In this roundup of developments in digital health, we highlight the key news and announcements from August and September.

Medtech Insight

Medtech Companies Face Challenges And Choices When Going Public

By Barnaby Pickering 12 Oct 2021

In a panel discussion at The Medtech Conference, hosted by AdvaMed, CEOs discussed the challenges, benefits and technicalities surrounding an IPO.

Medtech Insight

CMS Dashes Industry Hopes For MCIT Rule Any Time Soon

By Ferdous Al-Faruque 14 Sep 2021

The US Medicare agency has proposed to withdraw a rule that would give temporary automatic coverage to breakthrough devices, stating the rule doesn’t meet its evidence threshold and could put patients at risk.

Medtech Insight

Industry Needs Direction And Support As Notified Body Powers Strengthen

By Amanda Maxwell 14 Sep 2021

Gone are the days when notified bodies needed to promote themselves to gain business. Now industry is left struggling to find services ̶ and the EU regulatory outlook is becoming worrisome.

Medtech Insight

2 Deaths Linked To Missing IFU For Cardinal Health Scalpel Used For Newborns

By Shawn M. Schmitt 20 Aug 2021

The Safety Scalpel N11 is a component of Cardinal Health’s Argyle UVC Insertion Tray, which was recalled because it didn’t include the scalpel’s instructions for use. The recall has been labeled high-risk class I by the US FDA.

Medtech Insight

Countdown To 2022 EUEA System As Russia Increases Post-Market Medtech Controls

By Ashley Yeo 13 Aug 2021

There are just 4.5 months left until the new harmonized Eurasian Economic Union medtech system becomes mandatory, signifying major changes in regional market access. EAEU member Russia is meanwhile strengthening its post-market medtech controls.