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Makers Of An Array Of Devices Can Now Report Malfunctions In Summaries To FDA. Did Your Product Make The Cut?

US FDA rolled out its Voluntary Malfunction Summary Reporting Program on Aug. 17, allowing device-makers and manufacturers of device-led combination products to send quarterly rollup adverse event reports to the agency. The program's overarching goal is for FDA to receive fewer individual Medical Device Reports and to lessen the time firms spend preparing them, while maintaining sufficient detail for the agency to effectively monitor devices.

FDA Safety Quality

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

Giant Turkish Medical Device Tender Postponed Again

A big tender for advanced imaging and patient monitoring devices originally had been scheduled by the Turkish Government for July 4, but it has been postponed, now for a third time, with the date set for October 31. The procurement effort, with an estimated value of about $10bn, is intended to furbish new city hospitals with locally produced high-tech medical devices, but it has been the target of controversy, and there are some speculations that it might be canceled.

Turkey Market Access Commercial

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

QUOTED. Aug. 20, 2018. Bradley Thompson.

Attorney and industry advocate Bradley Merrill Thompson argues in a recent Medtech Insight article that US FDA is pursuing expanded authorities for collecting and acting on post-market device data without congressional authorization. Read one of Thompson's recommendations here.

Quoted Regulation United States

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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

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

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

Australia Accepts Approvals By More 'Comparable' Overseas Regulators/Bodies

Australia has decided to make greater use of medical device approvals in overseas markets to improve consumer access. 
Australia Policy & Regulation

OCD Indication Approved For Brainsway TMS Device

US FDA used its de novo review pathway to approve Brainsway Ltd.’s Brainsway Deep Transcranial Magnetic Stimulation System to treat obsessive compulsive disorder.

Approvals United States

Federal Court Sides With IRS In Medtronic Transfer Tax Dispute

The 8th Circuit Court of Appeals has sent a Medtronic transfer pricing tax dispute back to US Tax Court after finding that the tax court verdict hadn’t addressed several relevant factors. IRS initially asked for $1.4bn in back taxes in the case.

Medical Device Regulation

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

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

Set Alert for Commercial

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

Medtech Money Flow: M&A And VC Deals, Aug. 6-19, 2018

This edition of Medtech Money Flow rounds up the M&A and venture financing deals, as recorded in our M&A and VC Deal Trackers, for the two weeks between Aug. 6-19, 2018.

Deals Financing

Federal Court Sides With IRS In Medtronic Transfer Tax Dispute

The 8th Circuit Court of Appeals has sent a Medtronic transfer pricing tax dispute back to US Tax Court after finding that the tax court verdict hadn’t addressed several relevant factors. IRS initially asked for $1.4bn in back taxes in the case.

Medical Device Regulation

Terumo Aneurysm Device Gets FDA Panel Date

US FDA's Neurological Device Panel is set to meet Sept. 27 to weigh the merits of a PMA submitted for the WEB embolization device for treating aneurysms.

Advisory Committees Neurology

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

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

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

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

iQuity Shifts From Test-Maker To Data Miner And Analyzer

Nashville-based genomics company iQuity is building a data mining and analytics platform that will predict and monitor chronic diseases from public and private datasets from large populations.

Clinical Trials Diagnostics

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 high-field 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
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