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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
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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.

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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

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

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

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Medtech Insight

Coronavirus All FDA Inspections Of Chinese Manufacturing Facilities Come To Screeching Halt

By Shawn M. Schmitt 17 Feb 2020

In a late Friday news statement, agency head Stephen Hahn also warned of possible “shortages of critical medical products” The US agency has suspended all routine surveillance inspections in China through the end of March because of coronavirus fears, commissioner Stephen Hahn announced late on 14 February. Despite expecting medical product shortages, Hahn said the agency is being proactive: “We are not waiting for drug and device manufacturers to report shortages to us” before acting. The timing of Hahn’s statement – at 6 p.m. EST on a Friday, at the beginning of a three-day US holiday weekend – suggests he isn’t particularly excited to share the information.

Topic Coronavirus

View article
Medtech Insight

QUOTED. 24 January 2020. Megan McSeveney.

30 Jan 2020

The FDA has readied plans for hastened emergency-use approvals of coronavirus test kits after an infected US citizen returned to Washington State from Wuhan province in China. See what the FDA’s Megan McSeveney said about it here.

Topic Drug approval Coronovirus FDA

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Medtech Insight

CDC Shares Blueprint For Coronavirus Diagnostic With US State Laboratories

By Sue Darcey 30 Jan 2020

A new coronavirus test template developed by the US Centers for Disease Control and Prevention is being refined by the agency so it can be shared with domestic and international partners to help identify more cases of the virus. In the meantime, state labs can use the posted assay for coronavirus on the CDC’s website for testing of residents within their jurisdiction and send results to the CDC.

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Medtech Insight

Diagnostics Development For Coronavirus Begins As Second US Patient Tests Positive

By Sue Darcey 30 Jan 2020

Bioresearchers at the Centers for Disease Control and Prevention are hoping that diagnostic platforms previously used to develop tests for outbreaks of other epidemic respiratory diseases, including SARS and MERS, can be built on to develop new diagnostics to detect more cases in the current coronavirus outbreak, US infectious disease authorities say. This comes as more patients are monitored around the US for the disease, and a Chicago woman returning from China tests positive.

Topic Drug approval Clinical Trials Coronovirus Policy and regulation

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Medtech Insight

FDA ‘Stands Ready’ To Fight Coronavirus Via Emergency-Use Test Kits While WHO Mulls Virus Spread, Gets Out Guidance

By Sue Darcey 30 Jan 2020

The US Food and Drug Administration (FDA) stands poised to proceed with hastened approvals for 2019-coronavirus (nCoV) diagnostics, treatments and vaccines, if a public health emergency is declared, after an infected US traveler who caught the disease in Wuhan, China returned from the province to Washington State. Spread of the disease has reached a crisis level in China, and the World Health Organization met on 22 and 23 January to consider what actions to take to contain the virus, while issuing an interim laboratory test guidance for use in diagnosing the disease.

Topic Drug approval Clinical Trials Coronovirus Policy and regulation

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Medtech Insight

Diagnostics Sector On High Alert As Wuhan Coronavirus Spreads

By Brian Yang 29 Jan 2020

The latest figures from China's National Health Commission show infections of the new Wuhan coronavirus are continuing to pile up, spreading to more cities in the country and abroad as travel for the Lunar New Year festival goes into high gear. Meanwhile, diagnostics companies are rushing to have test kits ready.

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Medtech Insight

CES 2020: Panel Discusses Health Care In 2040 – Empowered Consumer, Digital Transformation, Data Sharing, Open Source

By Marion Webb 29 Jan 2020

An expert panel at CES 2020 discussed Deloitte's vision for health care in 2040, with the empowered consumer managing their own health, enabled by a new ecosystem of secure, open access to data and "nudges" to change behaviors. Consulting firm Deloitte foresees outside disruptors dismantling the traditional health-care system, but panelists from Johnson & Johnson and Anthem flexed their muscles.

Topic Business Strategies Digital Health

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Medtech Insight

MDSAP And USMCA: 3 Ways Mexico Can To Come Up-To-Speed With The Single-Audit Program Targeted By New Free-Trade Accord

By Shawn M. Schmitt 29 Jan 2020

The US-Mexico-Canada (USMCA) treaty calls for the three countries to “recognize audits” performed under the Medical Device Single Audit Program. MDSAP is already used by device makers in the US and Canada so they can undergo one audit by an accredited third party to satisfy quality regulations. That leaves Mexico as the odd country out when it comes to using the popular program – and that means it has some catching up to do after the USMCA is ratified by all three nations. Former longtime FDA official Kim Trautman weighs in on how Mexico can incorporate MDSAP into its regulatory framework.

View analysis
Medtech Insight

Medicinal Products Expert And Established Devices Leader Head Commission's Medtech Unit

By Amanda Maxwell 27 Jan 2020

Erik Hansson remains deputy head of devices in a move to the European Commission’s DG Sante from DG Grow. He now answers to a newly appointed devices head who shares a common educational background but whose recent pharmaceutical role may unsettle the devices industry.

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Medtech Insight

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 1)

By Shawn M. Schmitt 15 Jan 2020

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this first installment of a 10-part series, a procedure for hosting inspections is addressed.

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Medtech Insight

Exec Chat: CES 2020: For FDA's Amy Abernethy It's About Data, But Also Community Engagement

By Marion Webb 15 Jan 2020

Amy Abernethy, FDA's principal deputy commissioner, sat down with Medtech Insight during CES 2020 to discuss the agency's progress on the Technology Modernization Action Plan, the pre-certification program for digital health products, and the FDA's plans for 2020.

Topic Digital Health FDA

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Medtech Insight

Execs On The Move: Two Top Appointments At RTI Surgical; A CEO Promotion At Guerbet

08 Jan 2020

RTI Surgical, a surgical implants company, hired a global spine president and an original equipment manufacturer products president; Guerbet, a maker of medical-imaging products, promoted its chief commercial officer to CEO; and more.

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Medtech Insight

FDA Will Keep Listening To Patient-Engagement Experts

By Ferdous Al-Faruque 08 Jan 2020

The US agency says in a 6 January Federal Register notice that it’s keeping its Patient Engagement Advisory Committee in place through October 2021 so it can gather more patient feedback that will come in handy when regulatory decisions need to be made. The committee, formed after the agency made a cultural shift to consider patient input on the types of products it allows on the market, was supposed to expire October 2019.

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Medtech Insight

Official: European Parliament Signs Off Council of EU's 4 Extra Years For Class I Upclassified Devices

By Amanda Maxwell 18 Dec 2019

Medtech industry gets best seasonal gift as Council of EU and European Parliament agree on longer transition period for upclassified Class I medical devices. But how many notified bodies are still auditing products under the medical device directives?

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Medtech Insight

FDA Proposes End To Quarterly Reporting On HDE, PMA Decisions

By Elizabeth Orr 18 Dec 2019

A proposal from the US FDA would end quarterly publication of PMA and Humanitarian Device Exemption verdicts in the Federal Register. The agency says the practice is inefficient and duplicates online publication.

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Latest headlines

Medtech Insight

25 Feb 2020

Cardiovascular Sales & Earnings Round-Up: Medtronic TAVR Disappoints While Abbott And Boston Scientific See Structural Success In 2019

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Medtech Insight

24 Feb 2020

Start-Up Spotlight: "Cheeky Tech" – How Binah.Ai Uses Math, Plethysmography And AI To Extract Vital Signs From A Person's Cheeks

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Medtech Insight

24 Feb 2020

Top Lobbyist: User Fee Deal Should Focus On Agreements Already In Place

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Medtech Insight

21 Feb 2020

Start-Up Snapshot: Barcode Diagnostics, Personalized Cancer Drug Screening

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Medtech Insight

21 Feb 2020

Class I Recall On Abbott Coronary Catheters

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Medtech Insight

21 Feb 2020

QUOTED. 21 February 2020. Nancy Messonnier.

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Medtech Insight

21 Feb 2020

New Real-World Data Show Benefits Of Abbott's FreeStyle Libre Technology

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Medtech Insight

21 Feb 2020

Philips Expert Urges Device Makers: Update Quality Systems To Conform To Revised Risk Standard ISO 14971

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Medtech Insight

21 Feb 2020

Crosswalk: ISO 14971:2007 Vs. ISO 14971:2019

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Medtech Insight

20 Feb 2020

Castor’s Data Platform Will Make Medical Research More Efficient

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Medtech Insight

20 Feb 2020

Start-Up Snapshot: CorNeat Vision’s Implantable Artificial Cornea

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Medtech Insight

20 Feb 2020

Medtech Companies Need To Do Better At Patient Engagement, Expert Says

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Medtech Insight

20 Feb 2020

European Debut For CMR Surgical’s Versius Surgical Robot In Two UK NHS Hospitals

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Medtech Insight

20 Feb 2020

Device Week, 20 February 2020 – Industry Concerns Grow As Clock Is Running Out On EU MDR

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Medtech Insight

20 Feb 2020

Grail Starts PATHFINDER Trial To Evaluate Multi-Cancer Blood Test For Early Cancer Detection

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Meet the team

Editor

Amanda Maxwell

Editor, European Regulatory Affairs Editor

Amanda specializes in

Diagnostics
Medical Devices
Medtech
Policy & Regulation

+36 year(s) experience

Medtech Insight

Editor

Neena Brizmohun

Editor, Deputy Editor

Neena specializes in

Policy & Regulation
Biosimilars
Biotech
Diagnostics
Generics

+33 year(s) experience

Management

Ian Haydock

Management, Editor In Chief, Pharma, APAC

Japan

Ian specializes in

Policy & Regulation
Biopharma Pipeline Strategy
Commercial Strategy
Pricing & Reimbursement

+32 year(s) experience

See all analysts

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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, European Regulatory Affairs Editor

Neena ​ Brizmohun

Editor, Deputy Editor

Ian Haydock

Management, Editor In Chief, Pharma, APAC

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