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SCAI2018: New Study Shows 3D Printing Helps Prevent Leaks In Heart-Valve Patients

The clinical use of 3D printing got a boost when interventional cardiologists presented data at the annual meeting of The Society for Cardiovascular Angiography and Interventions that supported th4 technology's effectiveness in helping to predict paravalvular leak in patients undergoing transcatheter aortic valve replacement. The implantation of an ill-fitting valve that can lead to paravalvular leak is a common risk of TAVR procedures.

Cardiovascular Clinical Trials Research & Development

FDA Readies Digital Health Pre-Cert Program For Lift Off

US FDA laid out its proposed starting model to launch the pre-certification program for digital health products, including a matrix for when pre-certified app and software developers could bring new or modified products to market with either streamlined or no pre-market review.

Digital Health Regulation FDA

MITA Seeks Third-Party Servicer Buy-In For Quality Standards Pending FDA Report

The Medical Imaging Technology Alliance has pulled together a consensus body of original equipment manufacturers, third-party servicers and others to create voluntary quality management system standards for servicing advanced imaging and other medtech equipment, while stakeholders look ahead to an FDA third-party servicing report due in May.

Diagnostic Imaging Standards Regulation

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 US 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

Gottlieb Unveils Next Steps In Digital Health Plan

The US FDA Commissioner outlined six new updates to the agency's digital health plan, including a new guidance, the next steps for pre-certification and a digital health focus for drugs.

Digital Health Regulation FDA

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Policy & Regulation Explore this Topic

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Hong Kong Seeks Feedback On New Advanced Therapy Rules

Hong Kong is consulting on proposals to include advanced therapies in its regulatory framework for pharmaceuticals.

EU MDR Software Rules Are Not Being Revised; Will Guidance Help?

Some in industry are voicing concerns that the EU Medical Device Regulation's "Rule 11" that classifies software is too stringent. Sources in Brussels say no substantive revision is planned, but guidance on software classification is anticipated.

Digital Health Regulation Europe

Opinion: The Importance Of Consistent Regulation And High Standards For All Servicers

In this guest editorial, Consensys Imaging Service President Jim Spearman argues that third-party servicers of devices need to be held to the same quality management system standards as original equipment manufacturers – including mandatory reporting to FDA of adverse events and alterations they observe rendering the equipment they service unsafe or ineffective.

Diagnostic Imaging Regulation

Orthopedists Asked CMS To Stop Mandatory Bundled-Pay Models

Orthopedic surgeons never favored mandatory bundled-payment programs such as the Comprehensive Care for Joint Replacement model. In fact, in comments to CMS, surgeons requested that the US Center for Medicare and Medicaid Innovation make the programs voluntary and scale them back.

Orthopedics Reimbursement

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

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

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

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

Quality Control & Compliance Explore this Topic

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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

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

Commercial Explore this Topic

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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

Directional Deep Brain Stim Firm Aleva Pumps Up In-House Commercial Expertise

Aleva Neurotherapeutics has made two senior management appointments  as it prepares to take its first deep brain stimulation product to CE mark approval and to market.

Neurology Appointments

Bigger Vascular Surgery Player On The Scene With Terumo's Vascutek, Bolton Merger

Terumo has merged its two subsidiaries, Vascutek and Bolton Medical, to create a $200m-revenue player in the peripheral vascular implant scene.

Cardiovascular Surgery

Allergan Pays $4m In Two Lap-Band Settlements

Device manufacturer Allergan has agreed to pay $4m in two separate settlements involving the Lap-Band bariatric surgery device.

Compliance Legal Issues

Device Company Reports Data Breach

Oxygen device manufacturer Inogen is recovering from a data breach. The company disclosed in a financial filing that hackers accessed private data from approximately 30,000 customers.

Cybersecurity Digital Health

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

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

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

QUOTED. April 26, 2018. Francine Lane.

Clinical-trial disclosure requirements can be a major complication for device firms. See what TrialScope VP Francine Lane has to say about it.

Clinical Trials Compliance

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