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Better Reimbursement, More Incentives Needed For Peds Device Development, Stakeholders Tell FDA

At a recent pediatric medical devices workshop at US FDA headquarters, the focus turned less to regulatory burdens and more to lacking reimbursement and financial incentives as barriers to bringing child-focused products to market.

Reimbursement Pediatrics FDA

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 Research & Development

The QSR/ISO 13485 Maze: How FDA's Satellite Device Rules Will Complicate A Quality System Regulation Rewrite

Kim Trautman, who authored the Quality System Regulation in the 1990s, says US FDA officials tasked with retooling the QSR will have to consider an array of other device-related rules that address complaints, product recalls and traceability – just to name a few – to make sure those requirements will still be met by manufacturers.

Regulation Standards Quality

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

QUOTED. Aug. 21, 2018. Kim Trautman.

When FDA rewrites its Quality System Regulation, it will have to consider satellite device rules that address complaints, product recalls and traceability – just to name a few – to make sure those requirements will still be met by device-makers. So says Kim Trautman, who wrote the QSR in the 1990s. See what she said here.

Quoted Regulation Standards

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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

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

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

Pressed Into Service Without Enough Thought: Small Firms In Germany Voice IP Fears Over EU MDR

German medtech companies are keeping up the pressure for practical changes to be made to the EU Medical Device Regulation to limit its potentially damaging effects on product innovation and patient care, and drawing on recent support from German state economy ministers.

Germany EU

Warning Letter Roundup & Recap – Aug. 21, 2018

No device-related warning letters were released by US FDA the week of Aug. 21.
Device Warning Letters FDA

Lack Of National Planning For No-Deal Brexit Makes UK Device Shortages More Likely

The trade association, NHS Providers, has warned of shortages and stockpiles of medical devices in the UK, as well as problems with public health and disease control, if contingency planning for a “no-deal” Brexit is not coordinated at national level.

Brexit Reimbursement

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

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

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

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

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

Commercial Explore this Topic

Set Alert for Commercial

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 M & A

Medtronic's Eyes Are Still Peeled For M&A, But Organic Growth Is The Primary Goal

Medtronic may not have hit the headlines with any M&A deals this year so far, but the medtech giant has turned in an impressive set of first-fiscal quarter results driven by strong product sales. Organic growth, according to CEO Omar Ishrak, is currently the company's main goal, but it won't dismiss any tuck-in acquisitions that complement this organic growth and the firm will act promptly when the right opportunity comes knocking.

Sales & Earnings Companies

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

Starts & Stops: Aug. 13-19, 2018

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made Aug. 13 through 19, including trial announcements from Smith & Nephew, Creavo Medical, Elixir Medical, Abbott, and Medtronic.

Starts & Stops Research & Development Innovation

Global Device Approvals, Weekly Snapshot: Aug. 13-19, 2018

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. This week, two Health Canada approvals, and more.

Approvals Research & Development

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

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

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
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