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Hong Kong Medtech Regulators Face Need For System Update

Speed and efficiency are apparently on the minds of Hong Kong's regulators, who have proposed to shorten approval times for medical device registrations, and are considering granting earlier approvals, subject to certain criteria. Stakeholders are showing guarded optimism in early responses.


Hong Kong Regulation Medical Device

Market Intel: Digital Tech At The Heart Of Cardiology Innovation

Digital health technologies from smartphone applications, wearables, digital weight scales and telehealth are rapidly changing the landscape of cardiac care, offering new tools for engaging cardiology patients and enhancing cardiologists' workflows. There is a lot of hype, but also some real promise. Here's a look at what's happening and some expert insights on the benefits and challenges these new innovations represent, as well as market projections. Digital health was a major topic of discussion by cardiologists and entrepreneurs during this year's Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego. This is the second in a series of articles on the future of cardiovascular technology, spotlighting discussion and presentations from TCT.

Digital Health Cardiology Innovation

Medtronic Vet Christopher Barry Takes Helm At Nuvasive

About three years after becoming CEO of NuVasive, Gregory Lucier is ceding the role to Barry, who has led Medtronic's Surgical Innovations business, effective Nov. 5. Lucier will continue to serve as chairman of the board for the San Diego-based minimally-invasive spine surgery technology company.

Appointments Commercial Companies

Q&A: Ireland's Success In Attracting Medtech Companies

Medtech Insight talked to Rachel Shelly, the Head of Medical Technologies for IDA Ireland, about the Irish government's continuing efforts to attract medtech companies, the implications of Brexit, and the growing emphasis on data-analytics within the medtech industry in Ireland.

Ireland Brexit Market Access

Voters Likely To Pick And Choose Among Device Industry Favorites In Close Races

Among the very tight Republican and Democrat contests anticipated in this November’s US midterm elections are more than a few device industry-favored candidates, according to a review of the incumbents’ voting records and recent polling data.

Elections Legislation United States

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Getting The Words Right: Device Documentation And Translation in Asia

Oracle Health Sciences

Although the medical device sector has seen increasing harmonization of regulations both globally and regionally, market-entry requirements in Asia still retain a significant degree of localization, particularly as they relate to product labeling and documentation.

Download the article to learn more about the challenges and potential rewards of device documentation and translation in Asia.

The article reviews:

  • New regulatory reforms and their impact
  • The role and limitations of localizing software
  • Opportunities to translate for growth

Read Article

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Policy & Regulation Explore this Topic

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Only Health-Care Case At US Supreme Court This Fall Looks At Preemption

The Supreme Court will hear arguments this fall in a lawsuit concerning whether FDA decisions can protect drug manufacturers from lawsuits filed under state failure-to-warn clauses. Device companies should also watch it, some attorneys say.

Medical Device Legal Issues Policy & Regulation

European Commission Sheds Light On MDR/IVDR Progress In Vital Update

A new "rolling plan" provides deadlines for implementing actions, and other efforts, that are necessary to get the new EU Medical Device and IVD Regulations off the ground.

Europe Regulation Medical Device

Device-Makers Need Open Up More On Cybersecurity In Pre-Market, Draft Guidance Says

A new update to the pre-market cybersecurity guidance issued four years ago reflects how US FDA's thinking on the issue has evolved, as more cases of device vulnerabilities have surfaced. Among the key updates are recommendations for sponsors to submit a cybersecurity "bill of materials" in product labeling to better coordinate with end-users and to use a two-tiered risk management approach.

Cybersecurity Digital Health

Proposed 510(k) Changes Elicit Some Industry Skepticism

Two 510(k) pilots from US FDA indicate the agency's desire for faster, easier clearances. But some observers aren’t sure if they’ll lead to real improvements.

Regulation Medical Device

US FDA Shelves Proposal To Mandate Home-Use Device E-Labeling

A controversial 2016 proposed rule that would have required manufacturers of many class II and class III home-use devices to electronically submit device labeling information to US FDA will not be finalized, the agency affirmed in the Oct. 17 HHS Unified Agenda document. The agency also signaled plans to imminently finalize a broad device classification rule, and other updates.

Regulation Medical Device

Warning Letter Roundup & Recap – Oct. 17, 2018

No device-related warning letters were released by US FDA the week of Oct. 17.

Device Warning Letters FDA

Alzheimer's Is A Repeat Target For FDA Breakthrough Device Path

NeuroDiagnostics LLC said its investigational Alzheimer's disease test had been designated by US FDA as a Breakthrough Device. This is at least the third company to achieve that recognition for technology targeting Alzheimer's this year.

Neurology In Vitro Diagnostics

Australia Requires Patient Cards With All New Implants From Dec. 1

Requirements relating to patient cards and information leaflets for all implantable medical devices are based on the new EU medtech rules, but Australia has chosen to implement these earlier to address consumer information gaps.

Australia Policy & Regulation

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

FDA Hasn't Publicly Released A Device-Related Close-Out Letter For 5 Months, Defeating Purpose Of Program

Medical device manufacturers under the dark cloud of a US FDA warning letter work hard to close them out, and, importantly, receive a close-out letter from the agency that is posted online for everyone to see. Yet FDA hasn't publicly released such a missive to device companies since May – the longest gap since the close-out program began in 2010. FDA says it's aware of the problem.

FDA Compliance

Device Week, Sept. 21, 2018 – Medtech’s Next Top Maturity Model, Part 4

Medtech Insight’s Shawn M. Schmitt talks about Part 4 of “Medtech’s Next Top Maturity Model,” his feature series on the appraisal of device-makers’ manufacturing capability and maturity. This episode focuses on appraisers affiliated with Pittsburgh's CMMI Institute and describes the hurdles they must clear to be part of a US FDA pilot program that uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) framework.

Device Week Quality Control

Assessing A Device-Maker's Manufacturing Capability Is Serious Business For These 2 Longtime CMMI Appraisers. Here’s Their Story

From training classes to onsite observations, two lead appraisers affiliated with Pittsburgh's CMMI Institute describe the high hurdles they jumped to be part of a flourishing US FDA pilot program that aims to elevate product, manufacturing and process quality at device firms. The pilot uses an industry-tailored version of the tried-and-true Capability Maturity Model Integration (CMMI) framework that's been around for decades. Beth Layman, an appraiser who has assessed more than a hundred companies in a variety of industries, says appraisers can't just be book-smart – rather, they must also possess a select set of personal skills, including flexibility and open-mindedness. Her fellow appraiser Thayne Hill, who "was there in the early days" of the Capability Maturity Model, says device-makers are often leery of appraisers because of past negative interactions with regulators, which can make his job challenging.

The fourth of a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry.

Quality Control FDA

Commercial Explore this Topic

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Device Week, Oct. 18, 2018 – Digital Health Market Intelligence; New Blood Therapies Harvested From The Ocean

In this edition of Device Week, Medtech Insight's Marion Webb gives an overview of her new Market Intelligence article on innovative digital technologies applied to cardiology and Catherine Longworth reports on a Hermarina – a company in Brittany helping to build France's "blue economy" based on marine resources – which has developed several products, including a blood-replacement therapy, from a certain type of sandworm.

Device Week France Biologics

Philips Goes Fishing For Start-Ups With Healthtech AI Ambitions

Royal Philips has launched a global artificial intelligence collaboration program with start-up companies that will allow innovators in the area to work with the group's global innovation hubs. The company is looking to build and scale promising ideas and consider them for further collaboration.

Digital Health Artificial Intelligence

Apple And Zimmer Biomet To Study Patient Experience With Joint Replacement Surgery

The study will evaluate Zimmer Biomet's mymobility app on the Apple Watch and iPhone to guide patients undergoing knee or hip surgery through both pre- and post-op care.

Clinical Trials Digital Health

Sequana Medical Pumped About NASH's Market Potential

Following a fresh injection of funding, Sequana Medical is gearing up to grow its European business and begin a pivotal US study for alfapump, its implantable, automated pump for the continual removal of ascites. The Belgian company is positioning itself as a key player in the growing liver disease treatment market.

Financing Liver & Hepatic

Execs On The Move: Promotions At BD, Abbott, LuxCath and Varian Medical

Recent moves up the ladder: new COOs at Beckton Dickinson and Abbott, a chief technology officer at LuxCath, and a chief growth officer at Varian Medical. In addition, the chairman of BTG announced his decision to depart at the end of the year.

Appointments Commercial

Robert Ford Steps Up At Abbott Labs

The company's device business chief is expanding his portfolio as Abbott's new president and chief operating officer, leading to some speculation that he is being positioned to be the next CEO.

Appointments Commercial

Medtech Money Flow: M&A And VC Deals, Oct. 8 - 14, 2018

This edition of Medtech Money Flow rounds up the M&A and venture financing deals, as recorded in our M&A and VC Deal Trackers, between Oct. 8 and Oct. 14. 
M & A Deals

Clinical R&D Explore this Topic

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Results Recap: Neovasc's Tiara TMVR Succeeds In 12 Patients

Results Recap is Medtech Insight's exclusive summary of clinical trial results that have been announced or published in the past week, based on information collected by Meddevicetracker. This week's edition covers the week of Oct. 12 - Oct. 18, including trial announcements from PositiveID, Smart Meter, Access Vascular, and Neovasc.

Tracking Trials Innovation Clinical Trials

Global Device Approvals, Weekly Snapshot: Diabetes Tech In Canada

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Among the four added this week, Tandem Diabetes and Medtronic both gained integrated insulin pump system approvals in Canada.

Approvals Diabetic Care

Starts & Stops: Abbott And Edwards Update TAVR Trials; Enrollment Complete In Medtronic Resolute Onyx High-Risk Trial

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made Oct. 8 through Oct. 14, including trial announcements from Abbott Laboratories, Medtronic, Edwards Lifesciences, Carag AG, DJO Global, RTI Surgical, and Terumo.

Starts & Stops Tracking Trials

Temple Hopes To Be Center Of New Medtech Boom In Texas

Temple, Texas, is not the first place that comes to mind as a medtech industry hotspot, but the small city wants to be the anchor of a "medtech triangle" in central Texas. It currently boasts the 5,000-square foot Temple Health and Bioscience District facility with space, equipment, guidance and networking opportunities for medtech start-ups. The hope is it will grow and attract investment and more high-paying jobs.

US States Business Strategies

Exec Chat: Billy Cohn Talks About His J&J Play In Texas

The surgeon and serial device inventor has been getting Johnson & Johnson's Center for Device Innovation off the ground this year on the vast Texas Medical Center complex, and he says it's like nothing he has ever experienced.

Exec Chat Innovation

Q3 US Device Approvals Snapshot: Apps Up, Original PMAs Down

Mobile apps made major headway into the world of US FDA regulation in the third quarter, with de novo go-aheads for two Apple Watch heart-rhythm apps and the first FDA approval of a smartphone app to support contraception. Meanwhile, original PMA-approval volumes continue to lag in 2018. Here's an infographic to spotlight US device approval trends during the third quarter, July through September.

Approvals FDA

Global Device Approvals, Weekly Snapshot: Seeing And Hearing

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. A smart contact lens, self-fitting hearing aid and laser eye surgery device are among the new additions to the tracker.

Approvals Innovation