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Spinal Implants: Finding A Manageable Regulatory Pathway Through Complex EU MDR Wording

Efforts are underway by EU notified body groups to encourage a uniform interpretation of the EU MDR when it comes to the risk classification of spinal implants. Their work could also reduce the amount of unnecessary notified body and expert panel work on some implantable devices.

Medical Device Europe Policy & Regulation

Podcast: Legal Expert Advises On Patentable Subject Matter As Courts Send Conflicting Message

Three major cases have provided different interpretations of what is considered patentable subject matter, and to top it off a new guideline from the US Patent and Trademark Office has added to the confusion, according to a legal expert. Harness Dickey’s Chris Cauble walks us through what patent-seekers need to know and how to prepare their patent filings in this interview (podcast and transcript).

Intellectual Property Innovation Digital Health

Market Brief: Bone Densitometer And Bone Turnover Markers Will Reach $373.1M In 2023

The global market for bone densitometers and bone turnover markers will reach $373.1m by 2023, driven in large part by the rising aging population and rising prevalence of osteoporosis.

Commercial Market Intelligence Orthopedics

Warning Letter Roundup & Recap – Feb. 19, 2019

A Beverly Hills doctor was slapped with a US FDA warning letter for quality systems, Medical Device Reporting and pre-market issues related to a device used during breast augmentation procedures, and an Oyster Bay, NY, specification developer of the Better Bladder device was instructed by the agency to hire a consultant to help fix its quality systems issues. Two other missives were released this week – the first device-related warning letters posted online by FDA since early December 2018.

Device Warning Letters FDA Enforcement

QUOTED. Feb. 20, 2019. Karl Vahey.

When a device-maker is trying to figure out what went wrong with a troublesome product, launching a failure investigation is a must. But a firm can find itself in hot water quickly if it kicks off the investigation with a weak or incorrect problem statement, Cardinal Health's Karl Vahey says.

Quoted Quality Safety

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Pulse Of The Industry 2018: How Medtechs Will Create Value In The New Health Ecosystem

In the 12th edition of EY’s medtech report, The Pulse of the Industry, they examine the annual performance of the medical device industry in the context of the technological advances and rising customer expectations associated with the Fourth Industrial Revolution. To thrive in this transformative age, medtechs must adapt their business models to meet the increased expectations of consumers and other health care stakeholders.

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Policy & Regulation Explore this Topic

Set Alert for Policy

EU Offers Efficiency Tips For When Manufacturers Transfer Notified Bodies

What do incoming EU notified bodies need to do, and what shortcuts might they be able to take, when manufacturers transfer from one notified body to another?

Medical Device Europe Policy & Regulation

Lab Groups Disagree With GAO That Medicare Will Be Overbilled For PAMA Test Payments

A coalition of US laboratories and diagnostic test-makers say it strongly disagrees with GAO’s conclusions that labs will be overbilling Medicare for future payments under the “Protecting Access To Medicare Act of 2014”, and sent a letter to GAO managers last week arguing its case.

Reimbursement In Vitro Diagnostics Legislation

How Are Low-Risk Devices And IVDs Impacted By A No-Deal Brexit – In The UK And EU27?

Most low-risk medical devices and IVDs do not need notified body involvement in the EU. This means that, in the event of a no-deal Brexit, they are not impacted by UK government rules that focus on notified bodies. But what will change for low-risk devices and IVDs in the UK post-March 29, the UK's scheduled EU exit day?

Medical Device Europe

Australia Tries Again At Tightening Personalized And 3D-Printed Device Rules

The Therapeutics Goods Administration has begun a second public consultation on how it intends to improve its rules for 3D-printed and other personalized medical devices after stakeholders called for more clarification to proposals made in 2017.

Policy & Regulation Australia

The Cost And Complexity Of Implementing The EU Medical Device And IVD Regulations

Three experts talk about what it takes logistically for medtech businesses to prepare for timely compliance with the new EU Medical Device and IVD Regulations, and they spell out some of the challenges companies have encountered during a panel discussion at the recent LSX World Congress in London.

Medical Device Europe

QUOTED. Feb. 18, 2019. Michael Carome.

At a recent meeting, a US FDA advisory committee cautioned the agency to very carefully consider risks and benefits prior to agency approval of any new pelvic mesh products. See what Public Citizen's Michael Carome said about it here.

Quoted Advisory Committees

Vagus Nerve Stim Gets New Chance To Prove Its Worth For Depression

The US Centers for Medicare and Medicaid Services loosened its long-running noncoverage policy for vagus nerve stimulation for treatment-resistant depression a little bit, with a tightly controlled coverage-with-evidence-development policy. Device-maker LivaNova hopes to launch a Medicare-covered study later this year.

Market Access Reimbursement

Trump Signs 2019 US Federal Funding Bill, Stopping Another FDA Shutdown; CDRH Sees $69M Boost

US FDA’s device center gained a total of $471.4m in budget authority, plus more than $200m that Congress authorized in user-fee funding for the current fiscal year, in a 2019 federal agency spending package signed into law Feb. 15 by the president that prevented a second agency shutdown. The $471.4m budget is roughly $69m more than was given to CDRH for FY 2018.

United States FDA

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

FDA Draft Guidance Outlines Agency's Plan To Offer Nonbinding Feedback On Form-483 Observation Resolutions

Device manufacturers would be able to get nonbinding feedback on their plans for how to resolve some Form-483 inspectional observations from US FDA officials under a new draft guidance released Feb. 15.

Guidance Documents FDA

Medtech Tips: First-Rate Problem Statement Key To Failure Investigations, Cardinal Health Quality VP Says

A clear, succinct problem statement is the backbone of a winning device failure investigation, Karl Vahey says. He notes that a well-developed statement is also useful to have on hand when regulators conduct a facility audit and review corrective and preventive action (CAPA) activities.

Medtech Tips Quality

Implant-Makers Can Get A Leg-Up On Safety With New Standard From ASTM International

The upcoming voluntary global standard F3306 aims to improve the safety of surgically implanted medical devices. F3306 describes a novel test method that assesses metal and other ions released from single-use, metallic, implantable devices, and their components.

International Standards

Commercial Explore this Topic

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Execs On The Move: Sales Execs Switch Spine Firms; New Chiefs At VentureMed, Cassini

Three spine sales VPs left Amedica for Xtant Medical, which also hired two additional sales execs last week. Meanwhile, angioplasty device firm VentureMed Group hired a new CEO, and ophthalmic diagnostic firm Cassini Technologies promoted for its top spot from within.

Appointments Commercial Medical Device

Nevro Files Patent Suit Against Stimwave

Chronic pain treatment company Nevro has filed suit against rival Stimwave Tech alleging patent infringement.

Legal Issues Intellectual Property

MDx Health Names New CEO

MDx Health has named a new CEO to lead its commercial growth following a disappointing set of results in 2018.

Appointments Commercial

Medtech Money Flow: M&A And VC Deals, Feb. 11-17, 2019

This edition of Medtech Money Flow rounds up the M&A and venture financing deals, as recorded in our M&A and VC Deal Trackers, from Feb. 11 - 17, 2019.

M & A Deals

QUOTED. Feb. 19, 2019. Walton Taylor.

The American Society of Breast Surgeons published new guidelines, recommending that genetic testing should be offered to all patients with a history of breast cancer. See what the American Society of Breast Surgeons' president said about it here.,

Quoted Commercial

QUOTED. Feb. 15, 2019. Larry Biegelsen.

Johnson & Johnson announced it will acquire robotic startup Auris Health for $3.4bn in cash, plus up to $2.4bn in milestones. See what Wells Fargo analyst Larry Biegelsen wrote about it here.

Quoted Deals

MDx Health Signs Exclusive Canadian Agreement

MDx Health has signed an exclusive distribution deal to make its liquid biopsy prostate cancer test available in Canada.

Canada Cancer

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Global Device Approvals, Weekly Snapshot: Tandem Diabetes Win

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, Tandem Diabetes Care gained US FDA go-ahead for the first "interoperable" insulin pump.

Approvals Research & Development Diabetic Care

Breast Surgeons Advise All Breast Cancer Patients Be Offered Genetic Testing

The American Society of Breast Surgeons published new guidelines, recommending that genetic testing should be made available to all patients with a history of breast cancer. The new recommendations are not in line with existing guidelines made by the National Comprehensive Cancer Network.

Cancer In Vitro Diagnostics

Device Week, Feb. 13, 2019 –  Femtech Draws Investment; Smith & Nephew/Nuvasive Merger Rumors Emerge

In this edition of Device Week, Medtech Insight’s Reed Miller talks to managing editor Marion Webb about the growing interest among investors in "femtech," technology that specifically addresses women's health issues that have been frequently overlooked in the past. And London-based reporter Catherine Longworth addresses the recent media reports that Smith & Nephew may make a bid for spine-device company Nuvasive.

Device Week Business Strategies

Global Device Approvals, Weekly Snapshot: Spine Device Duo

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, two spine device approvals from US FDA, and a CE mark for a new drug-eluting stent.

Approvals Research & Development

Results Recap: Personal KinetiGraph Provides Useful Information On Parkinson’s; Leviticus’ Wireless LVAD Power System Shows Promise In First Patients

Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition, covering Feb. 1 through Feb. 10, includes published results from trials of Global Kinetics’ Personal KinetiGraph movement recording system for Parkinson’s disease patients, Milestone Scientific’s CompuFlo Epidural System for epidural-block anesthesia, and Leviticus Cardio’s wireless Coplanar Energy Transfer system for left-ventricular assist devices.

Tracking Trials Research & Development

Impella Fails To Improve Mortality In Non-Randomized STOP-SHOCK

Results of a study published in December found that left-side circulatory support with an Impella pump was not associated with lower 30-day mortality compared with matched cardiogenic shock patients treated with an intraaortic balloon pump (IABP) or medical therapy.

Clinical Trials Research & Development

Abiomed, FDA Attribute High Mortality In Impella RP Post-Market Data To Patient Selection

FDA sent a letter to physicians alerting them to interim results from the post-approval study of Abiomed’s Impella RP right-heart pump system that suggest a higher mortality rate for patients than what was observed in pre-market studies. FDA believes the benefits of the Impella RP system continue to outweigh the risks for patients covered by the currently approved indication; it emphasizes to physicians the importance of early placement of Impella RP, and the importance of following proper inclusion and exclusion criteria when selecting patients. The results cited by FDA were announced about two months after results of a non-randomized study in Germany cast doubt on the benefits of Impella for left-sided support in cardiogenic shock patients.

Clinical Trials FDA