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Featured Stories


Quality, Safety, MDSAP A Focus For Medtech In New USMCA Trade Agreement

The new US-Mexico-Canada (USMCA) trade agreement includes language on enhancing regulatory compatibility between the three countries by recognizing quality systems audits performed under the Medical Device Single Audit Program (MDSAP). It also stipulates that each trading partner “consider its resources and technical capacity” in ensuring the safety, effectiveness and quality of devices – and more. Medtech industry advocacy group AdvaMed is praising the deal, reached by the three countries on 10 December.

Trade Policy Quality

ConMed’s ‘No Smoking’ Drive Has Multiple Benefits In General Surgery

ConMed Corp. is company of two halves  ̶  general surgery and orthopedics – and is readying itself for a renewed assault on these two markets on the back of a technology pipeline, targeted acquisitions and a new growth-winning culture, says CFO Todd Garner.

Companies Orthopedics Surgical Procedures

Impella Safety Update: Data Supports Pump For Qualified Patients

Updated data from a postmarket study of Abiomed’s Impella RP right-heart pump further supports the device’s safety for a specific patient population.

Cardiology Post Market Regulation & Studies Safety

MTI Top 100: Leading Medtechs See Steady Organic Growth In A Market On The Cusp Of Change

The disruptive medtech M&A of recent years was not matched in the past year for volume, but there were isolated outbreaks of major activity, as shown in our company rankings. 

International Commercial Sales & Earnings

Spotlight On Market Intel

Market Intel: After A Year Of Partnerships, Insulin Pump Manufacturers Will Face Fierce Competition In 2020

The insulin pump market is expected to grow to $5.1bn by 2023, driven by the increasing incidence of diabetes and adoption of next-generation hybrid closed-loop systems, which allow patients and health-care providers to better manage care. This first part of a two-part series highlights the rising competitive landscape of the four major players, Medtronic, Insulet, Tandem Diabetes Care and Valeritas, with insights from endocrinologists. The second part will look at the smaller players, which are gearing up to introduce new products in 2020.

Market Intelligence Diabetic Care

QUOTED. 11 December 2019. Tejas Patel.

Corindus Vascular Robotics Inc. expects its CorPath GRX robotic intervention system will eventually be part of a widespread system of "telerobotic" intervention sites operated by specialists located far away. See what Tejas Patel, an interventional cardiologist at the Apex Heart Institute in Ahmedabad, India, said about it here.

Quoted Innovation Clinical Trials

Latest from PR Newswire

Click here to access further medical device and diagnostics news.
 


Recent Tweets from Medtech Insight


Medtech IT: How To Stay Ahead As Technology Accelerates

Outdated medtech IT solutions are stopping people from efficiently performing their jobs, a survey has found. Read this whitepaper to view more survey results and discusses how tech is changing Medtech.

Read the Whitepaper

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Commission Bows To Member State Pressure And Offers Voluntary Concession To Eudamed Database Delay

The European Commission’s announcement of a lengthy delay to the Eudamed database launch date has generally been met with dismay, with member states challenging the decision. Now there is news of a concession.

Europe EU Medical Device

Has EU Sorted Expert Panels As Tsunami Of 700 Applications Pour In After Extended Deadline?

Only just over a month ago there were fears that the implementation of the EU Medical Device Regulation was going to be hampered by a lack of expert panel applicants. Now it seems there is no shortage. The news raises lots of questions about when and how the structure will now work.

Europe EU Medical Device

EU Guidance Document To Ensure Devices Are Assessed By Appropriately-Trained Reviewers

How do notified bodies ensure that their personnel, and the teams they allocate for conformity assessment of medical devices, have the precise knowledge and expertise needed? A new EU document gives guidance on this.

Europe EU

QUOTED. 12 December 2019. Scott Whitaker

US congressional leaders and medtech industry advocacy group AdvaMed are giving their full-throated endorsement to a US-Mexico-Canada (USMCA) trade agreement announced by the US Trade Representative's Office on 10 December. See what AdvaMed's president and CEO, Scott Whitaker, said about it in a statement here.

Quoted Trade

Warning Letter Roundup & Recap – 10 December 2019

No device-related warning letters were released by the US FDA the week of 10 December.

Device Warning Letters FDA

FDA Commissioner Nominee Hahn Advances To Full Senate, Despite Some Dems’ Reservations

Stephen Hahn, the Trump administration’s nominee to lead the US FDA, has been approved by the Senate Health, Education, Labor and Pensions (HELP) Committee, with some “no votes” from Democratic senators in leadership positions, and is expected to be considered by the full Senate this week.

Policy Legislation

FDA Holding February Public Meeting On Using AI In Radiology

The US agency will host a two-day meeting to discuss the evolution of artificial intelligence technology used to analyze radiological images when diagnosing patients and in advising radiologists to take optimal pictures. The takeaways from the meeting will be used by the FDA to help it develop its thinking on how to regulate such technology.

Regulation Artificial Intelligence

MDCG Due To Endorse Cybersecurity And Class I Guidances This Week; Expert Panels On Agenda

Not only is the EU due to be endorsing key guidance documents this week, but recent headline  topics, including appointing expert panels and the delay in setting up the Eudamed database feature on end of week Medical Devices Coordination Group meeting agenda.

Medical Device Europe

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Cybersecurity: Guidance Docs To Come, But Legacy Devices Still A Challenge

Increasing savvy around cybersecurity issues is driving regulators and trade groups to update their approach to the area, speakers from the US FDA and the American Medical Association said at this week’s FDA/CMS Summit.

Cybersecurity Regulation

Analyzing Quality Data Is Essential. Here’s What One Expert Says Your Firm Should Do To Stay In FDA’s Good Graces

Device makers should make sure they have adequate resources to analyze quality data they take in so they can prevent the recurrence of nonconforming products, processes and procedures. That’s just one nugget of advice from former FDA investigations branch director Ricki Chase, who explains why collecting and properly handling such data is critical to complying with agency expectations in this Medtech Insight Q&A interview.

Quality FDA

Warning Letter Roundup & Recap – 3 December 2019

In the only device-related warning letter released by the US FDA this week, a manufacturer of surgical trays and kits was cited for quality systems violations.

Device Warning Letters FDA

Commercial Explore this Topic

Set Alert for Commercial

Execs On The Move: Owens & Minor And MicroPort See Big Departures; Dynatronics CEO Moving To BrainsWay

Owens & Minor finance boss joins drug-delivery device maker Intersect ENT; operations VP at MicroPort joins bioprosthetic heart maker Carmat; Dynatronics CEO will head neuromodulation product firm BrainsWay in January; and more.

Commercial Appointments Medical Device

ConMed’s Ortho Franchise Prioritizes Pipeline Over External Growth

ConMed’s ambitions in orthopedics are to be the clinician’s support, develop differentiated offerings and avoid “me too” activity, before all notions of leading the market rankings.

Orthopedics Companies

Patent Board Rejects Edwards’ Heart Valve Claim-Review Request

The US Patent Office has rejected a request by Edwards Lifesciences to review an Abbott patent on heart-valve technology, which could establish the patent as a key part of Abbott Laboratories’ arguments in a larger ongoing intellectual property case.

Intellectual Property Legal Issues

QUOTED. 10 December 2019. Viral Shah.

The global insulin pump market is expected to see significant growth, reaching $5.1bn by 2023. A new Market Intel story looks at the competitive landscape of the three leading companies in this market, Medtronic, Insulet and Tandem Diabetes Care, which are all expected to launch new products in 2020. See what Viral Shah, an assistant professor of medicine and pediatrics at the University of Colorado, said about the diabetes market here.

Quoted Market Intelligence

Market Intel: After A Year Of Partnerships, Insulin Pump Manufacturers Will Face Fierce Competition In 2020

The insulin pump market is expected to grow to $5.1bn by 2023, driven by the increasing incidence of diabetes and adoption of next-generation hybrid closed-loop systems, which allow patients and health-care providers to better manage care. This first part of a two-part series highlights the rising competitive landscape of the four major players, Medtronic, Insulet, Tandem Diabetes Care and Valeritas, with insights from endocrinologists. The second part will look at the smaller players, which are gearing up to introduce new products in 2020.

Market Intelligence Diabetic Care

CMR Surgical Names New CEO

CMR Surgical CEO Martin Frost is making way for a new boss to lead the surgical robotics company. Per Vegard Nerseth is set to join CMR Surgical in January 2020 as the company gears up for its most ambitious year yet.

Commercial Companies

Exec Chat: Koa Accel Learns From Past Mistakes To Help Medtech Inventors (Part 2)

Koa Accel CEO Francis Duhay tells Medtech Insight what his company looks for when choosing medtech ideas to support and how his experience as a physician and inventor informs his investment strategy.

Business Strategies Exec Chat

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Corindus Envisions Network Of CorPath Robots For Remote Neurovascular And Coronary Interventions

The physician who led the first-in-human robotic-assisted neurovascular intervention with Corindus’ CorPath GRX system believes the technology could revolutionize neurovascular intervention by allowing a centralized interventional team to remotely treat patients.

Innovation Clinical Trials Robotics

R&D Roundup, November 2019: LimFlow Starts Pivotal Trial Of Peripheral Shunt; Conservative Coronary Treatment Matches Intervention In Trial

An overview of November’s 10 most-read Medtech Insight articles on topics related to research and development of new medical technology.

Research & Development Clinical Trials

RSNA 2019: AI, Machine Learning Continue To Dominate Developments In Radiology

Artificial intelligence (AI) and machine learning took center stage at this year’s Radiological Society of North America meeting in Chicago, and the pervasiveness of AI tech in new product launches was further emphasized at the RSNA’s expanded AI Showcase exhibit.

Artificial Intelligence Diagnostic Imaging

Global Approvals Snapshot: November 2019

November’s approvals include the US FDA approval of Medtronic’s In.Pact AV paclitaxel-coated balloon, for the treatment of arteriovenous access in patients with end-stage renal disease, and a CE mark that expands the indication for Edwards’ Sapien 3 TAVR device to include patients at low-risk during surgery.

Approvals Clinical Trials

LimFlow On Target For 2021 US Launch Of Deep Vein Arterialization System

The results from the PROMISE I feasibility study give LimFlow confidence that the PROMISE II pivotal trial will prove that the LimFlow percutaneous deep vein arterialization system is a safe and effective alternative to amputation for patients with critical limb ischemia.

Clinical Trials Business Strategies

AHA 2019: French Registry Data Favor Edwards’ Sapien TAVR Over Medtronic’s CoreValve

Registry data from France shows transcatheter aortic valve replacement patients have better outcomes with Edwards’ Sapien balloon-expandable valves than with Medtronic’s CoreValve self-expanding valves.

Clinical Trials Research & Development

QUOTED. 20 November 2019. Jeff Shuren.

The US FDA has cleared the Pentax Medical Video ED34-i10T2, the first duodenoscope for the US market with a sterile, disposable elevator component designed to reduce the number of parts that need to be disinfected between uses. See what Jeff Shuren, director of the agency’s device center, said about it here.

Quoted Approvals
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