How Abbott is making good on investor promises

Abbott (NYSE: ABT) has won FDA approval of MR-compatible ICDs – an indication that it could be making good executing on key priorities it inherited when it acquired St. Jude Medical for $25 billion early this year. The news today “lends incremental credibility to our thesis that ABT can and will have a positive impact on STJ

DeviceTalks Boston: Here’s what you need to know

DeviceTalks Boston on Oct 2. will give attendees the chance to see some of the best minds in medtech live. There will be learning and networking opportunities galore. Read on and meet some of the top medical device leaders and experts who will be speaking – and discover other highlights from the upcoming show.   Next>> (See

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The 10 largest medical device companies in the world

Mergers & acquisitions continue to change the medical device landscape, as reflected in Medical Design & Outsourcing’s new Big 100 list. We pulled financial regulatory filings and reached out to major companies in some cases to create a list of the 100 largest medical device companies in the world, ranked by annual revenue for their

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How to design a successful embolic protection devices clinical trial

Embolic protection devices could reduce risks of interventional cardiac procedures such as TAVR, but their efficacy is hard to prove. David Novotny, Novella Clinical The embolic protection device (EPD) market is expected to grow into a billion-dollar industry if the device becomes the standard safety protocol for transcatheter aortic valve replacement (TAVR) and other interventional

China has a new medical device classification catalog: what you need to know

Grace Fu Palma, China Med Device The China Food and Drug Administration (CFDA) recently unveiled its new “Medical Device Classification Catalogue” – which has significant implications for medical devices registrations or renewals. The new catalog, announced Aug. 31 after a previous draft release and feedback period, goes into effect in less than a year – on Aug. 1, 2018.

Medtech complaint handling: Is there something to complain about?

Medtech complaint handling appears to be a work in process, according to Sparta Systems’s recent quality management market survey. The 2017 survey – which had 148 respondents in highly regulated industries including medical devices (23%) – found that nearly a quarter of those who answered did not have a well-defined and adopted complaint handling process. Only

The 20 largest medical device companies in the world

When it comes to the largest medical device companies, it’s a changing cast of players – as demonstrated once again in Medical Design & Outsourcing’s latest Big 100 list. We pulled financial regulatory filings and reached out to major companies in some cases to create a list of the 100 largest medical device companies in

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How Boston Scientific is boosting medical device value

Boston Scientific over the summer unveiled a new value-add for its implantable cardio devices: an online Trugevity calculator that lets physicians predict battery life. The idea is to help health providers quickly grasp the benefits of Boston Sci’s longer lasting EnduraLife battery technology, which the company touts has nine clinical studies and eight years of real-world

Here’s how GE wants to make anesthesia machines smarter

GE officials think their Mini Field Agent – a plug-and-play connectivity device used in many industries – could enable smarter use of anesthesia machines and other medical devices. The Boston-based conglomerate (NYSE: GE) is in the process of rolling out an implementation of the Field Agent to health providers as part of GE Healthcare’s Carestation

Medical device value: Here’s how you work it into your design

Public and private payers are increasingly demanding that health providers manage their patient populations more effectively and efficiently. That means that medtech companies can no longer merely rely on the strength of their technology to achieve reimbursement. They need to demonstrate “value,” too. “There’s a lot going on with the healthcare payment delivery systems to reform

RightEye raises $7.3 million from VSP Global, angel investors

Eyecare company VSP Global said today that it has made an investment in RightEye and its game-based vision tests. VSP (Rancho Cordova, Calif.) did not disclose the amount it provided RightEye (Bethesda, Md.) in the Series A round. But an SEC Form D that RightEye filed in June shows a roughly $7.3 million money-raise, which a spokesperson for

Heraeus Medical Components acquires Biotectix

Heraeus Medical Components is acquiring conductive polymer materials maker Biotectix. The deal, announced yesterday, will allow Heraeus to boost its medical electrode coating capabilities. Better electrode coatings equal better performance of sensing and stimulation electrodes used in diagnostic and therapeutic medical devices. Financial terms of the deal were not disclosed. “We constantly work with our medical

Did Congress just kill medical device innovation?

The Medical Device User Fee Amendments bill that Congress passed this year is more than an FDA fees hike for device companies; it could inhibit innovation, says Michael Drues, a regulatory consultant based outside Boston. That’s because MDUFA 2017 includes new user fees – about $23,000 for small companies and $93,000 for large companies – for

Gerresheimer gets new CEO

Gerresheimer (Düsseldorf, Germany) recently announced that Christian Fischer is its new CEO, effective September 1. Fischer succeeds Uwe Röhrhoff, 55, who left the company as of Aug. 31. Fischer joined Gerresheimer’s management board as a regular member on Aug. 1; he was previously president of performance chemicals at BASF in Ludwigshafen, Germany, where he spent 24 years. “The supervisory

How medical device risk management is connected with design controls

Medical device design controls play an important role when it comes to risk management, but the relationship isn’t always immediately clear. Intended use is especially important, says Jon Speer, founder of Greenlight.guru (Indianapolis), which markets a cloud-based quality management software. “If you don’t have a clear order or boundaries for conducting your risk management activities,