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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

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

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 Ophthalmology

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 United Kingdom

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Policy & Regulation Explore this Topic

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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 Combination Products

Warning Letter Roundup & Recap – March 20, 2018

In the only device-related warning letter released by US FDA this week, a specification developer of orthopedic implants was cited for quality systems violations.

Device Warning Letters FDA Enforcement

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

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

Cases Of Rare Lymphoma Linked To Breast Implants Increase

US FDA is now aware of 414 cases of breast implant-associated anaplastic large cell lymphoma. The agency says that updated medical literature estimates of the lifetime risk of textured breast implanted patients developing BIA-ALCL range between 1 in 3,817 to 1 in 30,000.

Regulation Safety

EU Regulations: The Catastrophic Costs Of Failing To Be A Trailblazer

Whatever the hurdles to compliance with the new EU Medical Device and IVD Regulations, procrastination will cost firms dearly, says Peter Rose, of compliance consulting firm Maetrics. In an interview with Medtech Insight, he stresses the urgency of quick action and calculates the cost to companies that are late to to comply.

Europe Compliance

Influential Medtech Group Hires New Chief

The Medical Device Innovation Consortium, a public-private partnership that has been instrumental in pushing some important US FDA policy shifts, has picked Pamela Goldberg as its new chief. The tech innovation consultant has worked for a similar group on the state level to advance medtech in Massachusetts.

Appointments Regulation

Saudi FDA Consults On Regulating Device Software, Distribution Requirements

Saudi Arabia has proposed adopting IMDRF guidelines on the regulation of medical device software. It has also issued a separate proposal to help medical device establishments comply with national regulatory requirements on the storage, handling and distribution of medtech products.

Policy & Regulation Safety

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

Commercial Explore this Topic

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Start-Up Spotlight: Payers, Pharma Clients Bank On Prognos' Artificial Intelligence To Predict Disease

New York-based health IT company Prognos recently secured $20.5m in Series C financing to build out its artificial intelligence capabilities, which it has applied to a giant diagnostic laboratory registry containing data from some 180 million patients. Given the shift to value-based health care and the high costs of treating chronic diseases, insurers might use information from this registry to predict the likelihood of disease and reach out to members to help head off illnesses. Pharma clients, in turn, can use the data to target physicians to help them deliver effective treatments.

Artificial Intelligence StartUps and SMEs Start-up Spotlight

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

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

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

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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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 Research & Development

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

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

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

Starts & Stops: March 5-11, 2018

Starts & Stops is a regular feature in Medtech Insight highlighting noteworthy clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers the trial announcements between Mar. 5-11, 2018, including clinical trial announcements from Mercator MedSystems, Boston Scientific and Brainsway Ltd.

Starts & Stops Clinical Trials