New to Medtech Insight?
Start a free trial today!
Register for our free email digests:
Register for our free email digests:
Jump To Section
Featured Stories
.jpg?w=784&hash=2201EF53F186189312E0E037A67AD9F5521C5B3B)
UK Medtechs Must Face Up To Brexit Certainty After Election Result
The December 12 UK general election returned a Conservative majority, the scale or which few would have predicted. It means that the new government can press on with its plans for Brexit, the uncertainty now surrounding only when, not if.

Under New Rule, Sponsors Are Not Required To Submit Multiple Paper Copies To FDA
The US FDA has finalized a new rule that updates a slew of agency regulations so sponsors no longer have to submit multiple paper copies of premarket submission applications. The agency says the rule could save companies millions of dollars.

Radiation Oncologist Stephen Hahn Wins Final Senate Confirmation As FDA Commissioner
The US Senate on a 72-18 vote approved radiation oncologist Stephen Hahn as Commissioner of the FDA on 12 December. Voting “no” were a block of liberal Democrats, including the ranking member of a key Senate health committee. Industry advocates and most senators said Hahn is an excellent choice to lead the FDA, but some fear he will not move quickly enough to ban candy flavors in vaping products favored by teens.

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.
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 Intel: Meet The New Voice In Health Care: Alexa Is Empowering Patients, Doctors
Market Intel: Precision Diagnostics And Focal Treatments Offer Personalized Approach To Prostate Cancer
Market Intel: 3D Bioprinting Forges Ahead With Mini Human Heart, Human Tissue
Market Intel: AACC 2019 – Roundup Of The Top 5 Diagnostics Companies

QUOTED. 13 December 2019. Todd Garner
ConMed's CFO Todd Garner told delegates at the Jefferies Healthcare conference that the company's orthopedic franchise is focused on its pipeline and meeting customer's needs. See what the CFO said about it here.
Latest News
Data Trackers
Policy & Regulation Explore this Topic
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.

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.

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.
Interim Eudamed Scheme: Early SRN Access To Aid Voluntary Actor Registration
The new Eudamed database may be delayed for two years, but the European Commission wants to allow early access to Single Registration Numbers before Eudamed goes live in 2022 to aid voluntary registration in the interim.
FDA Gives Sponsors A New Tool To Prove MRI-Compatibility
The US FDA has qualified a new modeling tool that could give sponsors more assurance that their products meet the agency’s expectations for MRI-compatibility.
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.
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.
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.
Warning Letter Roundup & Recap – 10 December 2019
No device-related warning letters were released by the US FDA the week of 10 December.
Quality Control & Compliance Explore this Topic
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
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.
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.
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.
Commercial Explore this Topic
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.

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.
Device Week, 12 December 2019 – Global Insulin Pump Market Will Face Fierce Rivalry Among Major Players In 2020
In this edition of Device Week, Medtech Insight's deputy editor Reed Miller chats with managing editor Marion Webb about her latest in-depth Market Intel story, the first part of a two-part series focusing on the competitive landscape of the global insulin pump market.
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.
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.
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.
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.
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.
Clinical R&D Explore this Topic
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.

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.
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.
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.
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.
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.
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.
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.
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Article
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.