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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.

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).

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.

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.

QUOTED. Feb. 21, 2019. Damien McDonald.
Device-maker LivaNova will put its vagus nerve stimulation system to another sham-controlled test in patients with treatment-resistant depression by leveraging a newly finalized Medicare national coverage determination, which covers patients with bipolar disease. See what LivaNova CEO Damien McDonald said about it here.
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Policy & Regulation Explore this Topic
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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?

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.
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?
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.
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.
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.
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.
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.
Quality Control & Compliance Explore this Topic
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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.
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.
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.
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.
Nevro Files Patent Suit Against Stimwave
Chronic pain treatment company Nevro has filed suit against rival Stimwave Tech alleging patent infringement.
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.
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. 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.
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.
Clinical R&D Explore this Topic
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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.
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.
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.
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.
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.
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.
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.
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