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Medtech Insight: global medical technology news & analysis

Access extensive coverage of global medical technology news and insight. Grasp global trends and gauge the impact of technologies like diagnostic imaging, drug delivery, 3-D printing and more.

You’ll instantly connect to the latest in global medtech developments with industry news, trends, deals, product developments, opinions, analysis, and context behind the headlines and more – all available at your fingertips.

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Real-time news and analysis
Regulatory development news
Company development news

Uncover medtech opportunities

Create your business-building strategy with Medtech Insight. Get the latest medical technology news and expert opinion on product developments, investment trends, deals, and shifts in industry dynamics, gaining insight into the evolving breakthrough medical technologies that will impact the industry. Plus, keep on top of regulatory changes and policy issues to see how these will impact the industry. Stay in touch with what your competitors are up to with news about manufacturing and approvals.

How it helps

Medtech Insight gives you quality news and insight into medical technologies in surgical, orthopedic, cardiovascular, and other markets.

Keep up to date with medtech and diagnostic developments across the globe
Search for competitor intelligence
Find investment and partnership opportunities
Understand M&A activity in the medical technology industry
Evaluate regulatory changes

How it works

As a subscriber, you’ll enjoy any-time, any-device access to the industry’s critical thinkers and opinion leaders. You’ll also receive access to Medtech Insight trackers, which monitor M&A and venture capital financing deals, product approvals, global regulatory guidance documents, US legislation, and US FDA warning letters.

Global content from trusted experts

More than a dozen experienced journalists and analysts based in Europe, US, and Asia bring you real-time analysis, news and opinion across the medtech landscape – covering regulatory, product and company developments.

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What's included

Real-time news and analysis

Analysis, news, and opinion from experienced journalists across the globe

Regulatory development news

Approvals, compliance & enforcement data, regulatory documents, & other data

Company development news

Information on M&A, deals, financial results, partnerships, and more

Product development news

The latest developments in clinical trial results, approvals, launches, & more

Tailored email alerts

Create and control email alerts tailored to your specific needs

Ask-the-Analyst™

Unlimited support for your research from experienced industry analysts

In-depth company coverage

Expert coverage of leading-edge companies, from large players to start-ups

Medtech Insight

Start-Up Spotlight: Creavo Medical, Diagnosing Myocardial Ischaemia With MCG

By Cathering Longworth 12 Sep 2018

UK medtech company Creavo Medical is trying to bring its magnetocardiography (MCG) technology to emergency departments worldwide for speedier diagnosis of heart disease. Distinguishing between ischemic heart disease and non-cardiac chest pain remains a challenge in emergency departments. Currently, all patients presenting with chest pain are assessed with electrocardiography and blood tests to rule out heart disease, but almost three-quarters of patients with chest pain do not have a cardiac-related condition.

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Medtech Insight

Medtronic Slapped With 2 FDA Warning Letters For Problems At Minnesota, Puerto Rico Sites

By Shawn M. Schmitt 12 Sep 2018

Two Medtronic facilities that make cardiac rhythm management devices were sent warning letters by US FDA because of quality systems issues. The sites were inspected by the agency after the firm initiated high-risk class I recalls for an array of CRM products earlier this year.

Topic FDA

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Medtech Insight

'Quik' Review Program Builds On US FDA eSubmission Efforts

By David Filmore 06 Sep 2018

The agency says 510(k)s submitted via an electronic template for any of about 40 product types might get a speedier review under a new pilot program.

Topic FDA

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Medtech Insight

CMR Surgical Launches Robotic System To Rival Intuitives Da Vinci

By Catherine Longworth 06 Sep 2018

UK-based CMR Surgical has debuted its new portable robotic system Versius. "Inspired by the human arm,” it is expected to assist in surgeries on European patients beginning next year. Versius is set to rival Intuitive Surgical’s da Vinci robot systems, the current market leader in robotic surgery.

Topic Digital Health

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Medtech Insight

Top Medtech Lobbyist Doubts Legislative Repercussions Of New Netflix Documentary

By Ferdous Al-Faruque 30 Aug 2018

AdvaMed's top lobbyist says a new documentary critical of the medical device industry and US FDA's device review pathways is unlikely to result in Congressional action. However, the group is talking to members on Capitol Hill to make sure they fully understand the context within which devices are reviewed and marketed.

Topic FDA Medtech

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Medtech Insight

Notified Body Capacity: TEAM-NB Members Way Ahead But Picture Clouded By Brexit

By Amanda Maxwell 30 Aug 2018

With the pressure increasing on manufacturers to have their products reassessed under the current EU medical devices directives or under the new EU regulations, where can capacity be found?

Topic Brexit Business strategies

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Medtech Insight

TrialScope Anticipates FDA Will Begin Inspecting Companies For Trial-Reporting Compliance

By Reed Miller 23 Aug 2018

US FDA will soon ramp-up enforcement of the clinical trial transparency provisions of Title VIII of the Food and Drug Administration Amendments Act of 2007, according to TrialScope Chief Strategy Officer Thomas Wicks. Those that fall foul of these new requirements will face penalties – and it looks like SMEs will be hardest hit.

Topic FDA

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Medtech Insight

Belgium Ushers In Complex New Country-Specific Registration Requirements Pending Eudamed

By Amanda Maxwell 22 Aug 2018

Belgium is introducing new registration requirements for medical device and IVD operators June 17, ahead of the full application of the EU's medtech regulations and new Eudamed medical device database.

Topic Business strategies

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Medtech Insight

Pathogen-Reduction Tech Gets Some Focus At FDA Panel Meeting, But Not Enough, Cerus Says

By Ferdous Al-Faruque 22 Aug 2018

While a panel of US FDA experts agreed pathogen reduction technology is a promising strategy for reducing blood platelet contaminations, they raised concerns about the cost of implementing the technology. The maker of the technology, Cerus, says the panel was under-briefed and distracted.

Topic FDA Policy and regulation

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Medtech Insight

New Reasons Not To Use EU MDR's Four-Year Extension, But Comply Earlier Or Retire Products Instead

By Amanda Maxwell 22 Aug 2018

The new EU Medical Device Regulation offers companies an option to market CE-marked devices for an extra four years under current directives. But more hurdles are being identified that make this option less attractive.

Topic Brexit Business strategies

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Medtech Insight

Mock Audits: Has Ambiguity In EU Led To Unfair Advantage?

By Amanda Maxwell 22 Aug 2018

There's been confusion and conflicting opinions about notified bodies conducting mock audits on companies' documentation to prove conformity with the impending EU Medical Device and IVD Regulations. Has the lack of clarity led to different and unfair practices? Does it matter?

Topic Medtech

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Medtech Insight

Higher Medtech Fees In Philippines Will Support Ongoing Regulatory Improvements

By Ashley Yeo 22 Aug 2018

Medtech regulatory fees in the Philippines are being increased for the first time since 2001. The country's FDA says the new fees will support quality improvements.

Topic Policy and regulation

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Medtech Insight

Exec Chat: JNJ's Innovation Partnering Strategy Goes Broad And Beyond 'Pinpoint Intervention'

By Tina Tan 22 Aug 2018

Medtech's biggest companies are becoming more hands-on in supporting early-stage technologies; their no longer just looking to pick up ready-to-buy assets. Among the most active in this approach is Johnson & Johnson, which has established several vehicles through which it supports and scouts external innovation. Medtech Insight chats with Mirren Mandalia, senior director of new ventures and transactions for medical devices at Johnson & Johnson Innovation, to find out what is driving J&J's technology sourcing strategy and how medtech innovators can work with the diversified health care giant.

Topic Company analysis Strategy

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Medtech Insight

Conformity And Confidence: US FDA Seeks To Build Trust In PreMarket Standards Declarations

By David Filmore 22 Aug 2018

FDA hopes the Accreditation Scheme for Conformity Assessment pilot will make it easier to trust the declarations of conformity to standards that are made by device-makers in pre-market submissions, rather than having to ask a lot of time-consuming questions. ASCA, included in the latest FDA user-fee agreement, also has important implications for the agency's global harmonization efforts. But many questions remain about its value and viability; they were on display at a recent two-day workshop at the agency's headquarters.

Topic FDA

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Medtech Insight

Compliance Corner: Follow These 4 Tips From FDA's Maisel For A Better Pre-Market Experience

By Shawn M. Schmitt 22 Aug 2018

Bill Maisel – the director of the Office of Device Evaluation within US FDA's Center for Devices and Radiological Health (among other titles) – says there are four things device-makers should do to make sure they succeed during the product-review process.

Topic Business strategies

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Latest headlines

Medtech Insight

18 Sep 2018

French Supreme Court Finalizes PIP Fraud Rulings And Executive Sentencings

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Medtech Insight

18 Sep 2018

MIACH Orthopedics Score NFLPA Investment For ACL Repair Tech

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Medtech Insight

18 Sep 2018

FDA Disputes Study On Breast Implant Safety

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Medtech Insight

18 Sep 2018

House-Passed Tax Bill Would Support Medtech Innovation, Lobbyists Say

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Medtech Insight

18 Sep 2018

Warning Letter Roundup & Recap – Sept. 18, 2018

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Medtech Insight

18 Sep 2018

QUOTED. Sept. 18, 2018. Scott Gottlieb.

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Medtech Insight

17 Sep 2018

DATA: Global Device Approvals, Weekly Snapshot: Apple Watch Wins FDA Love

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Medtech Insight

17 Sep 2018

DATA: Starts & Stops: Sept. 10-16, 2018

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Medtech Insight

17 Sep 2018

Israeli Robotics System Steers Closer To European Market

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Medtech Insight

17 Sep 2018

DATA: Medtech Money Flow: M&A And VC Deals, Sept. 10-16, 2018

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Medtech Insight

17 Sep 2018

QUOTED. Sept. 17, 2018. Kevin Coy.

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Medtech Insight

14 Sep 2018

DATA: Results Recap: Sept. 7-13, 2018

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Medtech Insight

14 Sep 2018

Patient Group Pushes FDA For LASIK Ban

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Medtech Insight

14 Sep 2018

FDA Looks To Whittle Down Dx Review Load With Pre-Certs, Third-Party Assists

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Medtech Insight

14 Sep 2018

Brexit: UK Promises Medtech Brexit 'No-Deal Consultation' As UK Teeters On Cliff Edge

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Meet the team

Editor

Amanda Maxwell

Editor, Medtech Regulatory Affairs Editor

Amanda specializes in

Policy & Regulation
Medtech

+34 year(s) experience

Medtech Insight

Management

Richard Faint

Management, Head of Medtech

Richard specializes in

Cardiovascular
CNS
Immunology & Inflammation
Infectious Diseases
Oncology

+27 year(s) experience

Analyst

Maureen Riordan

Analyst, Senior Deals Analyst

Maureen specializes in

Medtech

+22 year(s) experience

See all analysts

Next steps

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UK & Europe : +44 (20) 337 73737
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Japan : +81 3 6273 4260

Or please submit your inquiry via the form so that we can provide you the best possible customer service.

Medtech Insight: global medical technology news & analysis

Uncover medtech opportunities

What's included

Below are the Feature List

Real-time news and analysis

Regulatory development news

Company development news

Product development news

Tailored email alerts

Ask-the-Analyst™

In-depth company coverage

Pharma Intelligence: latest

Latest headlines

Meet the team

Below are the Analyst Profile

Amanda Maxwell

Editor, Medtech Regulatory Affairs Editor

Richard Faint

Management, Head of Medtech

Maureen Riordan

Analyst, Senior Deals Analyst

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