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Medtechs Must Address South Africa Market With Serious Intent And Sensitivity
South Africa is like no other country, having emerged through difficult decades of social inequality to now be embracing, among other things, modern health-care delivery via new regulatory structures, a national development plan and a National Health Insurance program (NHI). It is a potentially lucrative opportunity, but medtech players need to be wise to particular localization needs when embracing the South African market.

Abbott Launches ILUMIEN IV Trial To Drive Home Case For OCT
ILUMIEN IV is the largest ever prospective randomized trial to compare an intravascular imaging modality, plus angiography, to angiography alone in coronary interventions, according to Abbott. The trial will enroll up to 3,650 patients with high-risk, complex disease at 125 centers in North America, Europe and Asia to determine if OCT-guided stenting yields larger vessel diameters and improves clinical outcomes for patients compared to stent procedures guided by standard angiography.

Exec Chat: Breaking Into Asia? Think Long-Term And Engage, Accuron Medtech Chief Advises
For many medtech companies, Asia still holds significant opportunity compared to the persistent slow growth in the more mature US and European markets. But those looking to do business in this region need to plan long term. The biggest mistake is to think you can make a quick buck, says Abel Ang, CEO of Accuron Medtech, Southeast Asia's largest medical device pure-play. The Singapore-based industry veteran shares with Medtech Insight the lessons he learned from his time building businesses for medtech multinationals in APAC and other international markets. He also gives tips from his current experience introducing a disruptive technology to this region.

14 EU Countries To Link Genome Databases
EU is taking steps toward better understanding of the human genome by setting up an eHealth Cooperation Linking Genome Databases. It will provide the medtech industry with vital new information.

US Congress Asks For Input On Fighting Medtech Cybersecurity Threats
The House Energy and Commerce Committee is asking stakeholders to help prevent cyberattacks on medical devices and systems, citing recent attacks. One key issue cited by the committee: simply asking companies to update legacy devices or switching out those devices for newer ones is unfeasible.
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From Big Data To Cybersecurity, Today’s Device-Makers Face Myriad Compliance Risks – But Being Proactive Can Pay Off, Ex-FDA Official Says
Too many medical device manufacturers are struggling because they don’t have policies and systems in place to handle the ever-growing amount of data they receive about their products once they’ve gone to market. As a result, important signals can go undetected or unaddressed, leading to compliance problems and devices that are of poor quality – both of which could ultimately affect a device-maker’s bottom line.
Policy & Regulation Explore this Topic
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Device Week, April 19, 2018 – An FDA Safety & Quality Plan, Device Cybersecurity Galore, And A Pivotal Medtronic Clinical Trial. Oh My!
On this week’s Medtech Insight podcast, we discuss US FDA Commissioner Scott Gottlieb’s big plan to boost medical device safety and quality, important news regarding cybersecurity, and the latest on a Medtronic clinical trial.
FDA, CMS Will Use Parallel Review For Pain-Control Alternatives To Opioids, Medicare Official Says
The Medicare agency is working with US FDA on a parallel review process for non-addictive medical device pain control products and non-opioid drug alternatives to treat chronic pain, Kimberly Brandt, a CMS deputy administrator, told the Senate Finance Committee April 19.
QUOTED. April 20, 2018. Rosa DeLauro.
US Rep. Rosa DeLauro had a tense exchange with US FDA Commissioner Scott Gottlieb over the agency's handling of Bayer's Essure birth-control device. Check out what the Rhode Island democrat said here.
Challenges Prompt Canada To Adapt MDSAP Transition Plan
Health Canada is making it easier for device manufacturers to transition to the Medical Device Single Audit Program by the 2019 deadline.
Abbott Issues New Cybersecurity Patch For Cardiac Devices
After Abbott recently settled a case against short-seller Muddy Waters, the company has put out a second cybersecurity patch for certain St. Jude radio-frequency enabled cardiac devices to stop potential hackers from harming patients.
Gottlieb Defends US FDA 2019 Budget, Device Safety Plan In House
Members of a US House Appropriations Subcommittee interrogated FDA Commissioner Scott Gottlieb on the agency's proposed 2019 budget and his newly released device safety plan. One fierce critic, Rep. Rosa DeLauro, D-RI, attacked Gottlieb's efforts to allow third-party certifiers to approve device quality manufacturing processes, and said his safety plan looked like a "high-risk" action plan.
QUOTED. April 18, 2018. Tanya Vogt.
South Africa is undergoing a transition to a new regulatory regime. Check out what South African Medical Technology Industry Association's Tanya Vogt had to say about it here.
New Safety Framework Mixes Current Efforts, New Investments At US FDA
In a new "action plan," FDA is stitching together a plethora of ongoing and proposed initiatives to help spur product safety and quality efforts through increased regulatory authority and more incentives for device-makers.
Quality Control & Compliance Explore this Topic
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Challenges Prompt Canada To Adapt MDSAP Transition Plan
Health Canada is making it easier for device manufacturers to transition to the Medical Device Single Audit Program by the 2019 deadline.
How To Interpret EN ISO 13485 To Meet New Regs: Pivotal EU Document Published
A new document has just been published to help manufacturers and notified bodies meet the quality system requirements of the new EU Medical Device and IVD Regulations. BSI's Paul Sim explains its value.
FDA Sends Record-Low Warning Letters To Device-Makers In 2017 As Agency Takes More Personalized Compliance, Enforcement Tack
Medical device firms were issued 35 quality-related warning letters by US FDA last calendar year – the lowest number recorded since the agency's Quality System Regulation came into force in 1996. Officials in FDA's device center stressed in an interview with Medtech Insight that there's no specific reason why so few letters were mailed to companies in 2017, although they said the agency's ongoing compliance and enforcement outreach to device-makers might have played a role in last year's anemic count. Also: Might FDA apply "least burdensome" concepts to its warning letter and close-out processes?
Commercial Explore this Topic
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Jury Awards Plaintiff $68M In Bard Mesh Case
C.R. Bard has lost the first transvaginal mesh case to be tried in New Jersey, but there are another 150 to go in the state. A Bergen County jury awarded $33m in compensatory damages and $35m in punitive damages to a woman who says she's experienced chronic pain and other complications since receiving two of the company's transvaginal mesh products in 2009.
QUOTED. April 19, 2018. Abel Ang.
For device-makers that want to capitalize on opportunities arising from Asia's ever-burgeoning health-care systems, relationships are indeed critical to a successful APAC business strategy. Check out what Accuron Medtech CEO Abel Ang said about it here.
Boston Sci Wins Latest TAVR Patent Dispute Against Edwards
The European Patent Office sided with Boston Scientific on April 16 in agreeing to revoke an Edwards Lifesciences patent on a technology used in transcatheter aortic valve replacement (TAVR) devices.
Boston Scientific Bags nVision As M&A Roll Continues
Boston Scientific has expanded its gynecology/urology portfolio with the acquisition of nVision Medical, the maker of the first US FDA-cleared device designed to collect cell samples from the fallopian tubes for early ovarian cancer diagnosis.
MDIC Offers Contract To Develop Cybersecurity Playbook
As the threat of cybersecurity vulnerabilities in medtech has grown, so has interest in tackling the problem from both industry and regulators. In an effort to assist in developing a manual to help companies manage threats, the public-private Medical Device Innovation Consortium is taking research bids.
Device Debut: Philips, Digital China Health Push Teleradiology App To Chinese Market
Philips and Digital China Health, the largest provider of cloud-based healthcare services in China, have launched the Shinefly teleradiology application and services platform to help Chinese health-care providers manage their radiology workload and information output.
Clinical R&D Explore this Topic
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Global Device Approvals, Weekly Snapshot: April 9-15, 2018
A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.
OncoDNA's Biomarker Test Provides Useful Treatment Guidance In Trial
A new study sponsored by OncoDNA shows a combination of molecular tests could improve cancer treatment and help oncologists in routine clinical practice.
Victory From The Jaws Of Defeat: Angel Med Wrests Approval For Implantable Heart-Attack Monitor
A US FDA advisory panel unanimously voted down the AngelMed cardiac monitor two years ago. But venture-backed Angel Medical Systems was able to engage with the agency after the panel, and the firm ultimately achieved approval of the device designed to help detect heart attacks earlier. It’s a lesson in firms leveraging all the data they have at their disposal.
Global Device Approvals: Q1 Snapshot
The first quarter of 2018 brought 90 approvals from outside the US, including 56 in Europe, according to Medtech Insight's Approvals Tracker. The biggest category of approvals was cardiovascular, with several new drug-eluting stents and heart-valves coming through during the first three months of the year. Check out our infographic spotlighting the Q1 trends.
US Device Approvals: Q1 Snapshot
An infographic to spotlight US FDA device approval trends during the first quarter, January through March.
Starts And Stops: April 9-16, 2018
Starts & Stops features noteworthy clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers the trial announcements between April 9 and April 16, 2018. This week's edition include trial announcements from Abbott, Johnson & Johnson, Biotronik and Medtronic.
Harvard Cardiologist Tapped By Medtronic As VP Clinical Research And Analytics
Veteran cardiology device trial investigator Laura Mauri will join Medtronic as VP-Global Clinical Research & Analytics on Sept. 1, leading the development of new analytical and data science for the medtech giant.
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