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Clinical / R & D

Set Alert for Clinical R&D

Ethicon Expects Powered Circular Stapler To Address A Common Source Of Cancer Surgery Complications

The Echelon circular powered stapler for colorectal, gastric and thoracic surgery features Ethicon’s 3D stapling technology to evenly distribute compression and a gripping-surface technology that reduces compressive forces on tissue. The company expects the new system will reduce leaks at the staple line without compromising blood or lymphatic perfusion.

Innovation Research & Development Cancer

Clinical Trials

Set Alert for Clinical Trials

Latest From Clinical Trials

EU Or US First Choice For Launching Innovative Products? What You Really Need To Know

The tightening of the EU regulatory system will increase timelines for the availability of devices, especially novel, high-risk devices. But those who believe the US system will be quicker should not be so eager to jump to conclusions. Clinical data expert Sarah Sorrel explains why.

Medical Device Europe

Device Week, 4 October 2019 – Demant Group Recovers From Cyber-Attack; TCT Conference Highlights

In this week's podcast, senior reporter Catherine Longworth provides an update on how the Demant Group is recovering from a ransomware attack that forced the Danish hearing-aid manufacturer to shut down its IT systems, and deputy editor Reed Miller reviews the highlights of the clinical trial presentations at the recent Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.

Device Week Commercial

TCT 2019: EXCEL Shows Similar Five-Year Outcomes With PCI And Surgery In Left-Main Disease

Intervention with Abbott’s Xience everolimus-eluting stent yielded similar long-term results as bypass surgery in the EXCEL trial.

Clinical Trials Research & Development
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New Technology

Set Alert for New Technology

Latest From Innovation

Pentax Medical Pushes People, Product And Process Amid New US FDA Guidance

With the US FDA urging providers to transition away from fixed duodenoscopes to newer designs that reduce or eliminate reprocessing of the device, Pentax Medical is seizing an opportunity to increase supply of its disposable cap scope. Medtech Insight talks to the company’s global clinical officer, Garrett Hudson, on the challenges of endoscopy hygiene and the company’s response to guidance.

FDA Gastroenterology

Device Week, 17 October 2019 – A Mix Of Earnings and 'Taboo' Tech: Johnson & Johnson's Third-Quarter Earnings; Tech Innovations Around Sex And Death

In this edition of Device Week, Medtech Insight managing editor Marion Webb chats with deputy editor Reed Miller about the most recent earnings report from Johnson & Johnson, and talks with London-based Catherine Longworth about her upcoming "taboo" tech coverage from the 2019 Global Innovation and New Technology Health Event (GIANT).

Device Week Commercial

There's A Lot On FDA’s 2020 Guidance Priorities Lists – But The Software Pre-Cert Program Isn't One Of Them

The US FDA's device center has released its annual proposed guidance document lists for fiscal year 2020. Industry experts pointed out that the lists don't address the agency's software precertification program that it has been working on so hard. That may just mean the issue has fallen off of the FDA's radar or the agency needs congressional authority to move ahead with issuing guidances on the topic, an industry expert says. Also notable is a lack of an artificial intelligence guidance.

FDA Guidance Documents
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Set Alert for Approvals

Latest From Approvals

Hong Kong Tests Acceptance Of South Korean Device Approvals

A new trial in Hong Kong applies to class II, III and IV medical devices that are already approved by South Korea’s Ministry of Food and Drug Safety.

Approvals Hong Kong

New Guidewire 510(k) Guidance From FDA Advises On Coating Tests

Newly finalized guidance from the US agency updates its recommendations for 510(k) submissions for guidewires intended for use in coronary vasculature, peripheral vasculature and neurovasculature. The document, which replaces a 1995 guidance, reflects serious risks posed by certain guidewire coatings.

Review Pathway Guidance Documents

US FDA Issues Labeling Guidelines For Chemically Coated Devices

After discovering a correlation between certain chemically coated devices and serious adverse events, the agency has issued a couple of final guidance documents, including a labeling guidance to increase public awareness of the risks. The coating is meant to help physicians more easily slide devices – such as catheters and guidewires – into patients, but in some cases they’ve been associated with obstruction of blood vessels, stroke and death.

Regulation Approvals
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