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Does EU Regulation Of 3D-Printed Implants Expose Gap In MDR Regime?

Given that 3D printing is used for making device implants, many would expect tight regulation. But the EU Medical Device Regulation does not specifically regulate it, and there may be easier routes to compliance than companies think, according to attorney Joerg Schickert.

Europe Regulation Personalized Medicine

Clinical Trial Sponsors Take Heed: Study Disclosure Rules Are Expanding

The recent update of Title VIII of the Food and Drug Administration Amendments Act of 2007 clarifies the requirements for registering clinical trials and disclosing clinical trial results to the FDA, but many trial sponsors and investigators are still confused about their obligations under these rules as well as the rules governing clinical trial registration and closure abroad. Francine Lane, the VP of Global Transparency at TrialScope, talked to Medtech Insight about the challenges facing clinical trial sponsors trying to comply with these rules and offered some predictions about how these regulations will likely evolve in the future.

Clinical Trials Compliance Research & Development

More Changes Ahead For Medtech In South Africa As Final Reg Structure Nears

South Africa's medtech industry has much to look forward to, given the emergence of the new South African Health Products Regulatory Authority (SAHPRA) and the sheer volume of activity in recent years dedicated to establishing the mechanisms to secure fully regulated, safe and high-quality medical devices. But it's not the end of the road; there remain some tricky stretches ahead, including new "pricing" regulations, as discussed at the 2018 MedTech Forum.

South Africa Regulation Reimbursement

Medtech Money Flow: Weekly M&A and VC Deals, April 16-22, 2018

In this weekly feature, Medtech Insight presents a roundup of the previous week's M&A deals and venture financing rounds recorded in our M&A and VC Deal Trackers. This edition presents the transactions announced April 16-22, 2018.

M & A Deals Financing

QUOTED. April 25, 2018. Joerg Schickert.

The EU's new Medical Device Regulation doesn't appear to regulate 3D-printed medical products in the same way that all standard devices are controlled, Hogan Lovells attorney and life-sciences expert Joerg Schickert explains. See what he said about it here.

Quoted Europe Regulation

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Policy & Regulation Explore this Topic

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Mexico Adds New Regs For IVDs, Other Device Types

The latest version of the Mexico Pharmacopea includes new regulations for several device types, which appear to impose stricter regulations for diagnostics and some types of medical device software.

Mexico Regulation Medical Device

Vendor Oversight Program MedAccred Bestows First Plastics Extrusion Accreditation

Sunlite Plastics Inc. is the first and only manufacturer to be accredited to the industry-managed MedAccred for plastics extrusion.

Quality Control Compliance Companies

Reinvigorated German Innovation Strategy May Succeed Where Market Access Tools Have Failed

German medtech manufacturers hope that the fledgling coalition government's promise to give new impetus to the long-running national medtech strategy initiative will help achieve the very innovations that much-vaunted reimbursement fast-tracking mechanisms have failed to yield.

Germany Innovation

Warning Letter Roundup & Recap – April 24, 2018

US FDA did not release any device-related warning letters the week of April 24.

Device Warning Letters FDA

EU Does Not Plan To Integrate International Safety Reporting Scheme With Eudamed Database

The EU is recreating its medical device database to arguably become the most modern repository of vital medtech information, including on safety-related incidents. Will non-EU authorities get a look?

Europe Safety

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.

Cybersecurity Digital Health

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.

Personalized Medicine Policy

EU MDR/IVDR Compliance Might Benefit From New EU Blockchain Partnership

Blockchain has been highlighted as a helpful vehicle for communication and traceability in the medtech sector. The technology looks set to proliferate in the EU with a new cooperation partnership.

Europe Regulation

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

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.

Manufacturing Quality Control

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.

Standards Quality Control

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?

FDA Enforcement

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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.

Asia Pacific Market Access Business Strategies

QUOTED. April 23, 2018. Larry Biegelsen.

Check out what Wells Fargo analyst Larry Biegelsen had to say about why a global patent battle between Edwards Lifesciences and Boston Scientific on transcatheter aortic valve replacements will likely end in settlement.

Legal Issues Intellectual Property

Jury Awards Plaintiff $68M In Bard Mesh Case

CR 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.

Gynecology & Urology Legal Issues

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.

Quoted Asia Pacific

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.

Intellectual Property Legal Issues

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. 

Commercial Deals

Medtech Money Flow: Weekly M&A and VC Deals, April 9-15, 2018

In this weekly feature, Medtech Insight presents a roundup of the previous week's M&A deals and venture financing rounds recorded in our M&A and VC Deal Trackers. This edition presents the transactions announced April 9-15, 2018.

Financing Deals

Clinical R&D Explore this Topic

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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.

Clinical Trials Innovation Personalized Medicine

Global Device Approvals, Weekly Snapshot: April 16-22, 2018

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.

Approvals Innovation

Starts & Stops: April 17-23, 2018

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers the trial announcements between April 17-23, 2018. This week's edition include trial announcements from Jarvik, Admedus, Emboline and Endonovo Therapeutics. 

Starts & Stops Clinical Trials

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.

Clinical Trials Innovation

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.

Approvals Advisory Committees

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.

Approvals Clinical Trials

US Device Approvals: Q1 Snapshot

An infographic to spotlight US FDA device approval trends during the first quarter, January through March.

Approvals Innovation
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