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Pre-Certs, Test Groups And More: US FDA Outlines Possible New Dx Paradigm

The agency has responded to a draft diagnostics reform bill in Congress with proposed reforms that diverge some ways from the proposed legislation, but stick with the underlying goal of completely remaking how lab tests, including test kits and lab-developed tests, are regulated. The agency has put forward a proposal to establish a pre-certification process for test developers, divide most tests into high- or low-risk categories (but exempt many from pre-market review) and remove the concept of substantial equivalence.

In Vitro Diagnostics Legislation Regulation

QSR Author Kim Trautman Predicts What A Mash-Up Of FDA's Quality System Regulation And ISO 13485 Might Look Like

US FDA will face high hurdles as it works to write a new rule that would merge the agency's Quality System Regulation with international quality systems standard ISO 13485. That's according to Kim Trautman, a longtime industry insider who wrote the QSR in the early to mid-1990s. "It’s a clear heavy lift from a regulatory policy perspective" that could take as long as five years to complete, she says. In the meantime, Trautman offers some insight into what device-makers might see in a new hybrid quality systems regulation from FDA. She addresses everything from corrective and preventive action (CAPA) to labeling, and complaint handling to risk management – and more.

Regulation Standards Quality

Market Intel: Liquid Biopsy II – Emerging Companies Look For Liquid Gold

The potential to use a simple blood test to guide physicians in monitoring cancer therapies, detect early cancers, serve as a companion diagnostic to guide targeted therapeutics and predict the likely course or outcomes of disease in patients has spurred a lot of interest and innovation. Here's a look at emerging companies hoping to make an impact, including insights from interviews conducted with C-Level visitors at the recent Liquid Biopsy Conference in San Francisco. This is the second of a two-part series focusing on the global liquid biopsy market.

Cancer Personalized Medicine Commercial

Canadian Guidance On Pre-Market Cybersecurity Requirements Expected This Year

Canada's pre-market evaluation process for medical devices will soon include evaluating the adequacy of a manufacturer's risk control measures to address cybersecurity concerns.

Canada Policy & Regulation Safety

Device Week, Aug. 14, 2018 – The Promising Landscape Of Liquid Biopsy

On this week's podcast, Medtech Insight's Reed Miller talks to Marion Webb about her latest two-part Market Intelligence series on the liquid biopsy market.

Device Week Cancer Personalized Medicine

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Getting The Words Right: Device Documentation And Translation in Asia

Oracle Health Sciences

Although the medical device sector has seen increasing harmonization of regulations both globally and regionally, market-entry requirements in Asia still retain a significant degree of localization, particularly as they relate to product labeling and documentation.

Download the article to learn more about the challenges and potential rewards of device documentation and translation in Asia.

The article reviews:

  • New regulatory reforms and their impact
  • The role and limitations of localizing software
  • Opportunities to translate for growth

Read Article

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Policy & Regulation Explore this Topic

Set Alert for Policy

Less Burden For Medtech As Australia Adopts Electronic IFU

Medical devices for use by professional users in Australia can now be supplied exclusively with electronic instructions for use.

Policy & Regulation Australia Compliance

Canada To Introduce 'Pause The Clock' For Device & Drug Reviews

Canada is proposing a clock-stop in the device and drug review process to allow more time for the clarification of specific issues.

Review Pathway Canada Advisory Committees

Eight Device Accessories Could Break Free To Class I

The US FDA is floating eight categories of device accessories for low-risk, class I designation as part of its shift to addressing classification of accessories separately from "parent" devices. It also clarifies its approach to orthopedic instruments.

Regulation Medical Device

FDA Clarifies Export-Denial Appeals Process

New US FDA draft guidance attempts to clarify when and why the agency might deny device manufacturers an export certificate, as well as the review process to appeal such denials.

Regulation Trade

QUOTED. Aug. 16, 2018. Janine Jamieson.

There are calls for an independent watchdog group to facilitate implementation of the EU Medical Device Regulation. Combination products expert Janine Jamieson explains one potential benefit of such a group here.

Quoted Regulation

Is A Watchdog Group Needed To Monitor MDR/IVDR Implementation And Its Missing Pieces?

The EU medtech sector needs an independent watchdog group to help analyze the impact of the jerky steps toward implementation and head off potential crises, three experts tell Medtech Insight.

Medical Device Europe

Canada Announces New Infusion Pump Performance Standards

Canadian authorities are requiring new performance data to demonstrate the accuracy of some infusion pumps.

Canada Regulation

Warning Letter Roundup & Recap – Aug. 14, 2018

No device-related warning letters were released by US FDA the week of Aug. 14.
Device Warning Letters FDA

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Q2 Recalls Snapshot: Industry Sets Record Again With Most Quarterly Recalls Since '05

A record 360 recall events were initiated by device-makers in the second quarter of 2018, beating the previous high of 343 product recalls recorded in Q1. On a somewhat brighter note, the number of device units recalled in Q2 fell a whopping 80% from the prior quarter. Check out our Q2 recalls infographic.

Recalls Safety

MDSAP Auditors Aren't Applying A Consistent Auditing Approach, Medtech Group DITTA Claims In Letter To FDA

A letter from DITTA Chair Patrick Hope to a US FDA point person for MDSAP highlights concerns some device-makers have about the flourishing Medical Device Single Audit Program, including inconsistent auditing approaches from facility to facility, and long-delayed audit results and MDSAP certificates.

International Compliance

Case For Quality Belly-Flop? FDA's PMA Critical-To-Quality Pilot Has Zero Enrollees After 10 Months

Device-makers have given a collective shrug to US FDA's Premarket Approval Critical-to-Quality (PMA CtQ) pilot program, a Case for Quality initiative that aims to identify "critical-to-quality" attributes for an array of products and ensure that quality is built into devices at their earliest stages. Since the pilot began in September 2017, no firms have enrolled. FDA's Bleta Vuniqi surmises that the empty pilot might be a victim of a glut of FDA pilot programs. Meanwhile, the agency has been talking internally about ways that the fledgling PMA CtQ pilot could be absorbed by FDA's burgeoning CMMI maturity model pilot.

Quality FDA

Commercial Explore this Topic

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Endomag Outlines Commercial Ambitions Following Landmark FDA Approval

Endomag is making plans to shake up the US breast cancer market with its Sentimag and Magtrace combination breast cancer system, which recently earned US FDA approval. The company recently raised $10m to scale its commercial operations.

Companies Commercial Financing

Maquet Settles Lawsuit Brought After Patient Death

Device manufacturer Maquet has agreed to settle a lawsuit brought after a patient died when one of the company’s blood oxygenation devices broke.

Medical Device Surgical Procedures

UK Medtechs' Brexit Readiness Moves Up A Notch In Absence Of EU Deal Framework

The UK is unmistakeably in the period of the calm before the storm, and an enforced Brexit lull is in place. But the thoughts of UK and EU decision-makers – and UK medtech companies – are not straying too far from the upcoming trade deal negotiations and the business of making the best of Brexit, however and whenever it manifests itself.

EU United Kingdom

Profusa Raised $45M To Market PAD-Monitoring Implant In Europe

Digital Health company Profusa raised more than $45m in a series C financing round. The company plans to use the proceeds to bring its tiny CE-marked injectable biosensors, used to monitor tissue oxygenation in patients with peripheral artery disease, to key opinion leaders and clinicians in Europe.

Wound Management Digital Health

QUOTED. Aug. 14, 2018. Dawood Sayed.

The American Society of Pain and Neuroscience is teaming up with Ethos Laboratories to investigate the relationship of urine-measured biomarkers with pain interventions. See what ASPN President Dawood Sayed said about it here.

Quoted Personalized Medicine

Exoskeleton Company Ekso Bionics Names John (Jack) Glenn as CFO

Richmond, Calif.-based exoskeleton company Ekso Bionics named Jack Glenn as chief financial officer.

Appointments Commercial

Market Intel: Liquid Biopsy I – Analyzing Market Landmarks And Landmines

The worldwide liquid biopsy market is expected to reach $2.0bn by 2022, according to a new report by Meddevicetracker, "Oncology: Liquid Biopsy Products." The growth is driven by the rising global incidence of cancers, which, in turn, fuels innovation among companies to develop noninvasive diagnostic assays that obviate the need for tissue biopsy. This is the first in a two-part series providing an overview of the liquid biopsy market, as well as the technologies developed by the larger players in this space, and examining the biggest barriers and growth drivers. In the second part, we'll take a closer look at emerging companies in the sector and offer key insights from C-level attendees at the recent Liquid Biopsy Conference in San Francisco.

Cancer In Vitro Diagnostics

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Global Device Approvals, Weekly Snapshot: Aug. 6-12, 2018

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. This week, a new microstent for glaucoma was approved by US FDA.

Approvals Ophthalmology Innovation

QUOTED. Aug. 15, 2018. Kevin Brown.

Kevin Brown, physicist and global VP of scientific research for device-maker Elekta, says his company has rejected some product ideas because they ultimately wouldn't be profitable. See what he said here.

Quoted Innovation

Starts & Stops: Aug. 6-12, 2018

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made Aug. 6 through 12, including trial announcements from Hancock Jaffe, Medtronic, and LivaNova.

Starts & Stops Clinical Trials

LivaNova Finishes Feasibility Trial Of Transcatheter Mitral Valve, Anticipates 2020 CE Mark

PRELUDE feasibility study of LivaNova's Caisson transseptal transcatheter mitral valve replacement (TMVR) system is complete and the company the INTERLUDE CE Mark trial has begun, the company announced. The company is now working with the US FDA to finalize the protocol for the ENSEMBLE US pivotal trial.

Clinical Trials Innovation

Hindsight 20/20: Elekta's Kevin Brown

Hindsight 20/20 is a Q&A feature where veterans of the medtech industry share career highlights, specific achievements and hurdles they have faced. In this installment, Kevin Brown, global VP of scientific research at radiation therapy specialist Elekta, discusses the challenges of translating scientific ideas into breakthrough technologies that bring value to clinicians and patients. He also addresses his guiding principles for picking winning ideas and his journey bringing to market the world's first integrated MRI and radiotherapy system.

Hindsight 20/20 Innovation

QUOTED. Aug. 10, 2018. Ted Davis.

Active Implants is ramping up for a 2019 commercial launch of its NUsurface polycarbonate-urethane meniscus implant as it continues clinical trials in the US. The firm hopes to earn US approval for the device by the end of 2020. See what Active Implants CEO Ted Davis said about it here.

Quoted Clinical Trials

Global Device Approvals, Weekly Snapshot: July 30-Aug. 5, 2018

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. This week, EU and Australia approvals for Baxter's new infusion system, and more.

Approvals Research & Development