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Is Enough Being Done About Cybersecurity In The EU? Contradictory Views Raise Regulatory Questions

A recent report from the UK Royal Academy of Engineering suggests that more efforts are needed to ensure cybersecurity protections for medical devices. But a key European industry trade association says that cybersecurity is adequately addressed from a regulatory standpoint in the EU.

Cybersecurity Digital Health Europe

Start-Up Spotlight: Pertinax Pharma, Closing In On Wound Care With Slow-Release CHX Tech

A UK drug delivery firm is bringing its antimicrobial material to the global wound care market. Pertinax Pharma, a Bristol University spinout, is the developer of a slow-release technology that provides controlled and sustained delivery of the antiseptic, chlorhexidine.

Israel's Vision For The Future: Investors Open Eyes To Ophthalmology

As the global population ages, the demand for ophthalmic devices is expected to rise significantly. Medtech Insight meets with some of Israel's industry leaders who are developing cutting-edge technologies to address the ever-growing ophthalmic market.

Ophthalmology Ophthalmic Innovation

UK On Cusp Of Value-Based Procurement With NHS Future Operating Model Going Live

The UK's complex system of procuring medical technology for use in the National Health Service is being simplified. A new system will go live on May 8 under the Future Operating Model (FOM), an initiative that prioritizes outcomes-based rationales and allows for gain-sharing, while also targeting annual NHS savings. At this early stage, the device industry and health-care providers are both displaying a mix of optimism and skepticism.

Market Access United Kingdom Government Payers

President Signs Omnibus Bill That Leaves Device Funding Flat, Boosts FDA By $135m

The president has signed a 2018 appropriations bill to cover costs at federal agencies until Sept. 30. It provides budget authority funding (not including user fees) for US FDA's device activities at $330m – the same as in 2017 – but gives a total boost of $135m to the agency, up to $2.9bn. The president warned Congress he signed the bill "only as a matter of national security," because it contains increases in military spending.

Legislation Policy Medical Device

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Policy & Regulation Explore this Topic

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Brexit: Where Things Stand For Medtech

UK and EU leaders announced some progress on Brexit this week, establishing a conditional transition period after the UK exits the Union in 2019. But that does not resolve many questions and concerns in the medtech space about what's to come. Here is a comprehensive look at where things stand for medtech, based a discussion from this week's Device Week podcast.

Brexit Regulation Europe

US FDA: Bad Lead Test Results Tied To Test-Tube Stopper Chemical

An investigation by FDA and BD has concluded that a chemical used in some test-tube stoppers is the reason for false results on some blood-based lead tests from Magellan Diagnostics.

Compliance Recalls Enforcement

US Trade Rep Recommends Tariffs On China-Sourced Medtech, BioPharma Products

In addition to taxing foreign-made steel imports from certain countries, the US Trade Representative's office will soon recommend tariffs against Chinese-made biopharma and advanced medtech products, and other products in US/China competitive industries.

Trade Policy

US House Panelists Fault CMS For Cutbacks To Joint Replacement Bundled-Pay Program

The US Centers for Medicare and Medicaid Services' decision last fall to limit a joint replacement bundled program met with considerable push back from lawmakers this week.

Legislation Reimbursement

Surgeons Warned Of Overheating From NeuroBlate Probes During MRI Use

US FDA put out a class I recall notice and sent health-care providers a warning to avoid using Monteris Medical's NeuroBlate probes after at least one patient bled to death after the probe overheated. The agency says it can't conclude for sure the patient death was caused by the device, which is used to support brain surgery.

Recalls Safety

Device Week, March 22, 2018 – Brexit, And Where Things Stand For Medtech

On this week's podcast, a deep dive into what is happening with Brexit, and what it means for the medtech sector.

Brexit Europe

FDA Combination Product Submissions May Need More Drug Info

Recent guidance document revisions mandate that combination product sponsors provide additional information on the patent and exclusivity status of any drug components. The US agency addressed the changes in a March 20 webinar.

FDA Regulation

US FDA Extends Safety-Reporting Deadline For Certain Combination Products, Issues Guidance

After issuing a major combination product post-market safety reporting rule at the end of 2016, US FDA released guidance to add context for companies developing the products. The agency has also extended compliance deadlines in many cases until 2019.

Regulation Combination Products

Quality Control & Compliance Explore this Topic

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Abbott, Merck Like FDA's Plan To Amass More Summary Adverse Event Reports, But P&G Says There's A Better Way

While mammoth manufacturers Abbott Laboratories and Merck & Co. – along with device industry advocacy groups – are supporting the US agency's proposed Voluntary Malfunction Summary Reporting Program, Procter & Gamble Co. is urging FDA to think twice. In comments to the agency, P&G's principal scientist says the program, which will allow firms to submit Medical Device Reports to FDA quarterly in a bundled format for a wide array of products, should be scrapped and replaced with an 11-year-old congressional mandate that aimed to boost summary reports.

FDA Safety

FDA Warning Letters For Olympus, Fujifilm, Pentax: Duodenoscope-Makers Fail To Meet Agency's Post-Market Surveillance Study Order

US FDA sent the letters to Olympus Corp., Fujifilm Medical Systems USA Inc. and Pentax Medical after the firms failed to meet obligations to conduct Sec. 522 post-market studies on their duodenoscopes, the use of which caused a number of antibiotic-resistant superbug infections in 2013 and 2014.

FDA Enforcement

Stakeholders To FDA: It's A Bad Idea To Ask For More Adverse Events In Quarterly Summary Reports

Stakeholders criticized the US agency's plan to gather more adverse events in a summarized fashion under its proposed Voluntary Malfunction Summary Reporting Program. Ten commenters pleaded with FDA to reconsider its plan, while one industry attorney questioned why the agency never adhered to a 2007 congressional mandate that it collect more summary reports.

FDA Safety

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Oxford Nanopore Hits £1.5bn Valuation With Latest £100m Round

In one of the bigger private financing rounds seen this month so far, British genomics firm Oxford Nanopore Technologies has raised £100m ($140m) from a syndicate of APAC investors to expand its commercial activities. The latest funding round values the company at £1.5bn.

Financing Commercial Companies

QUOTED. March 23, 2018. Barak Azmon.

Israeli device-makers are strengthening ties with Australia, which has launched a major initiative to encourage innovation in health care. Check out what Notal Vision's Barak Azmon said about it here.

Quoted Commercial

QUOTED. March 22, 2018. Katarzyna Mazur-Hofsäss.

The head of Zimmer Biomet's EMEA division, Katarzyna Mazur-Hofsäss, is concerned about how the EU's new Medical Device and IVD Regulations will affect the market there. Check out what she said here.

Quoted Companies

Boston Scientific Scores March M&A Double Whammy With NxThera

In its second acquisition deal this month, Boston Scientific has agreed to pay up to $406m for NxThera, maker of the Rezῡm system for treating benign prostatic hyperplasia.

M & A Deals

Manufacturers Enter The Competitive Online Market For Contact Lenses

Almost one-third of contact-lens patients in the US order lenses online at least some of the time. Manufacturers such as CooperVision are introducing mobile apps that allow them to compete with online-only retailers like 1-800 Contacts.

Ophthalmic Retail

Device Debut: Dornier's New-Gen Laser Offers Faster Stone Treatment

German lithotripsy specialist Dornier MedTech has launched, in Europe, a next-generation holmium laser designed to allow faster and more accurate treatment of urinary stones.

Gynecology & Urology Innovation

QUOTED. March 21, 2018. Jason Bhan.

Start-up firm Prognos has a lofty long-term mission: to use artificial intelligence and other smart technologies to eradicate disease. Check out what company cofounder Jason Bhan had to say about Prognos' use of AI here.

Quoted Artificial Intelligence

Clinical R&D Explore this Topic

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Starts & Stops: March 12-20, 2018

Starts & Stops features noteworthy clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers the trial announcements between March 12-20, 2018, including clinical trial announcements from Boston Scientific, Biotronik, Johnson & Johnson and Edwards.

Starts & Stops Clinical Trials Innovation

TAVR Update: Edwards Delays European Launch Of Sapien 3 Ultra; New Medtronic CoreValve Data

Edwards originally predicted the Sapien 3 Ultra transcatheter aortic valve would hit the European market this quarter, but the company is now pushing that back to later in 2018 to wait for data from a small single-arm multicenter trial in intermediate-risk patients. In other TAVR news, long-term data supporting Medtronic's CoreValve line of TAVR systems was featured at the recent American College of Cardiology meeting.

Clinical Trials Approvals

QUOTED. March 20, 2018. Raul Nogueira.

Check out what Raul Nogueira, the principal investigator of the DAWN acute stroke clinical trial, had to say about the new paradigm for treating strokes that should result from the study data, which device-maker Stryker is getting out ahead of.

Quoted Approvals

Global Device Approvals, Weekly Snapshot: March 12-18, 2018

A snapshot of global medical device and diagnostics approvals recorded in Medtech Insight's Approvals Tracker during the past week.

Approvals Innovation

FDA Works To Connect Cardiac Device Registries

US FDA is working with manufacturers, researchers and other stakeholders to assemble a comprehensive network of registries of cardiac device data. But cardiologists and device firms say the project faces multiple challenges.

Regulation Research & Development

Stryker Pushes For Changes To Stroke Care After DAWN

Stryker's Trevo Retriever is the first stent retriever approved by US FDA as a front-line treatment for patients experiencing acute ischemic stroke up to 24 hours from symptom onset, matching the time window recommended in the latest professional treatment guidelines. Now, the company is trying to help the stroke-care system in the US catch up to the science.

Approvals Clinical Trials

Global Device Approvals, Weekly Snapshot: March 5-11, 2018

A snapshot of global medical device and diagnostics approvals recorded in Medtech Insight's Approvals Tracker during the past week.

Approvals Innovation