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Featured Stories


BSI Is Designated In Netherlands, Giving Clients Go-Ahead To Start Transfer Of Certificates

With a high level of uncertainty still surrounding Brexit negotiations,  UK-based notified body BSI can now offer its clients a more certain future by migrating their certificates to BSI Netherlands if they wish.

Medical Device Brexit Europe

Fresh From US FDA's Chief Counsel Office, Beth Weinman Talks Qui Tam And Compliance

Beth Weinman, a former enforcement lawyer in US FDA’s Office of Chief Counsel, recently joined the life sciences and FDA regulatory practice at Ropes & Gray. She spoke with Medtech Insight about whistleblower suits and FDA enforcement priorities.

Compliance Enforcement Legal Issues

Complying On Time With MDR/IVDR: What Options Are Open To Those In Trouble?

Manufacturers who have not managed to transfer their certificates from a UK notified body prior to Brexit, or who have not obtained certificates under the EU Medical Device or IVD Regulations in time, can not expect to receive a sympathetic hearing from the EU Commission. In an interview with Medtech Insight, Lawyer Alison Dennis examines options for medtech firms.

Europe Medical Device Policy

Execs On The Move: Coloplast, EOS, Notal Hire CEOs From The Inside

Promotions bring execs to the top spots at ostomy and wound-care specialist Coloplast AS, imaging solutions and ortho surgical care company EOS Imaging, and ophthalmics AI firm Notal Vision. Those and more recent medtech personnel moves.

Appointments Commercial Medical Device

Q3 Recalls Snapshot: Recalled Devices Slide In Third Quarter; Software A Nagging Issue

Good news for the medical device industry: After two record-setting quarters, the number of recalled products and device units fell in the third quarter of 2018. Yet device-makers are still having problems with software, which was the leading cause of recalls in Q3. Check out our Q3 recalls infographic.

Recalls Safety Quality Control

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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

Canada Consults On Licensing Of 3D-Printed Device Implants

A new draft guideline issued by Health Canada represents the first phase of a 3D-printing policy in Canada.

Canada Policy & Regulation Medical Device

Warning Letter Roundup & Recap – Nov. 13, 2018

The manufacturer of VascuLab devices used in vascular pathology was cited for quality systems and Medical Device Reporting violations in the only device-related warning letter released by US FDA this week.

Device Warning Letters FDA Compliance

UK MHRA Response To Brexit Questions Still Leaves Gaps And Uncertainty For Medtech

As UK Prime Minister Theresa May tries to get her cabinet to accept the draft Brexit agreement between the UK and EU, Medtech Insight looks at the potential confusion for medtech should she fail.

Brexit United Kingdom

How Belgium's New Local Distribution Rules Will Impact Companies Doing Business There

With new legislation imminent in Belgium on distribution rules for medical devices, how much more open is the market going to become, and what must companies be aware of? Two experts discuss.

Belgium Medical Device

Controversial Contraception Apps Among New Entries On EU Borderline Manual

There are six new entries in the latest version of the European Commission's manual on borderline products.

Europe Policy & Regulation

AdvaMed Making Push For Device Tax Repeal In Lame Duck Session

The "lame duck" session of Congress before newly elected members take their seats in January may be the best shot available for the device industry to win permanent device tax repeal, lobby group AdvaMed says. The group is making a major effort to repeal the tax before the new Congress takes over.

Legislation Policy

Special 510(k) Pilot Includes All Qualifying Submissions, FDA Says

US FDA officials clarified how devices can qualify for an ongoing special 510(k) pilot program during a Nov. 8 online seminar.

Regulation Medical Device

Device Week, Nov. 9, 2018 – What The US Midterms Mean For Medtech

On this week's podcast, David Filmore and Ferdous Al-Faruque discuss the results of this week's midterm elections in the US and what it could mean for the medtech sector.

Device Week Elections

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

US FDA Tweaks Direct Marking Rules In UDI Enforcement Delay

FDA’s latest update to Unique Device Identification compliance deadlines says the agency won’t enforce direct marking UDI rules for some existing devices if the UDI can be determined in other ways.

Enforcement Compliance

'An Unnecessary Editorial Revision': In Letter, MDSAP Council Rails Against ISO's Push To Change 13485 Quality Standard

The chair of the Medical Device Single Audit Program (MDSAP) Regulatory Authority Council is warning of "instability" in industry if the International Organization for Standardization (ISO) Technical Management Board has its way and makes changes now to international quality systems standard ISO 13485.

International Standards

ISO Wants To Tinker With Quality Systems Standard 13485:2016. Let ISO Know What You Think By Nov. 9

Device firms don't have to conform to the latest version of ISO 13485 until March 2019, yet the International Organization for Standardization (ISO) Technical Management Board is champing at the bit to open up the quality systems standard for a rewrite. In response, ISO Technical Committee 210 has developed a survey to determine how changing the standard will affect device-makers and other stakeholders. TC210 wants to "gather opinions from the users [of ISO 13485] to justify why no immediate revision is desired, especially in light of all the regulatory changes that are coming," TC210 delegate Kim Trautman says. The survey closes Nov. 9.

International Standards

Commercial Explore this Topic

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Market Intel: Apps for Epilepsy, Steps for Health, Meditation Guides, Mouth Labs Cross Digital Divide For Better Health

Startups at the convergence of technology and biomedical innovations showcased compelling innovations at this week's Exponential Medicine conference in San Diego. This article offers a roundup of new devices targeting a wide range of applications from neurology, cardiology, chronic diseases and wellness.

Innovation Analysis Commercial

QUOTED. Nov. 14, 2018. Matteo Lai.

Matteo Lai, CEO of a company that makes the first US FDA-cleared seizure-monitoring smart watch, says users don't care much about artificial intelligence or fancy technology. Rather, they simply want the device to be easy to use and to do its job. See what Lai said about it here.

Quoted Innovation

QUOTED. Nov. 13, 2018. Avi Fischer.

Abbott Laboratories pointed to success in its electrophysiology device business last quarter, driven by multiple products including the Confirm Rx insertable cardiac arrhythmia monitor, which the firm says is the thinnest in class, and is smartphone-compatible for more direct patient engagement. See what Abbott VP Ari Fischer says about it here.

Quoted Commercial

Q3 Earnings Spotlight: Ortho Firms Show Mixed Results Against US Pricing Pressure

Reported sales and earnings from the publicly traded orthopedics device companies showed mix results during the third quarter of 2018. NuVasive was the star performer in the group while, on the other end of the spectrum, Stryker continued to show strong growth across most its businesses, while Johnson & Johnson's orthopedic device revenue was near flat.</p>

Orthopedics Deals

Q3 Earnings Spotlight: Roche, Abbott, bioMérieux Lead IVD Company Results

Medtech Insight highlights Q3 2018 results from some of the leading IVD players. In this edition, we spotlight some of the big companies including Roche Diagnostics, Thermo Fisher Scientific, bioMérieux, and Becton Dickinson.

Commercial In Vitro Diagnostics

Q3 Earnings Spotlight: Abiomed Shines Among Cardiology Device-Makers

Reported sales and earnings from the publicly traded cardiovascular device companies show strong performance across the sector, spurred by new approvals and clinical trials, in the quarter that ended Sept. 30. Here's a recap of results from the cardio device companies that have reported so far, including Abbott, Abiomed, and Reva.

Commercial Cardiovascular

QUOTED. Nov. 8, 2018. John Damgaard.

RedMed Inc. is continuing to invest aggressively in its "software-as-a-service" offerings with the addition of MatrixCare, a provider of long-term post-acute care software. See what MatrixCare CEO John Damgaard said about it here.

Quoted Deals

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Abiomed Touts New Study Results, Potential To Revolutionize Heart-Attack Treatment

Promising new results from a pilot study of Abiomed’s Impella device to reduce damage after myocardial infarction sets the company up to start a pivotal study, which, if successful, could change how patients are treated immediately after an attack.

Clinical Trials Research & Development Cardiology

QUOTED. Nov. 9, 2018. Pete DeComo.

When ALung Technologies was selected in 2015 by US FDA to participate in the agency's Expedited Access Pathway program for its novel Hemolung device, the firm wasn't necessarily sure what it was getting itself into. See what ALung CEO Pete DeComo said about the pathway – now called the Breakthrough Devices Program – here.

Quoted Respiratory

Global Device Approvals, Weekly Snapshot: Parathyroid Detection, Diabetes Tech

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Two devices to help surgeons performing thyroid surgery made the list, as did several devices in the diabetes space.

Approvals Innovation

QUOTED. Nov. 2, 2018. Harold Safferstein.

With 25 device and diagnostics start-ups in its portfolio, the Pittsburgh Life Sciences Greenhouse aims to establish life-sciences companies in Western Pennsylvania by leveraging the area's top schools and best-in-class medical facilities. See what the Greenhouse's Harold Safferstein said about it here.

Quoted Innovation

Breathing Easy: ALung CEO Talks Novel Hemolung Device, FDA's Breakthrough Pathway, Landmark US/UK Clinical Trials

In a deep-dive sit-down interview with Medtech Insight, ALung Technologies CEO Pete DeComo dishes on US FDA's Breakthrough Devices Program and explains why his firm's novel artificial lung device, Hemolung, is worthy of traveling the expedited pathway to agency approval. DeComo also details two pivotal Hemolung clinical trials in the US and UK, and explains why Hemolung isn't marketing the device for commercial use despite being approved in 36 countries outside the US. He also talks about a future portable version of Hemolung, but noted that's not where ALung is focused right now. "Our first task is that first-generation technology – to get it to market, make it the standard-of-care, and then, if you are successful with all of that, you can do all of those wonderful other things as it relates to portability and wearability," DeComo says.

Respiratory Innovation

Life Sciences Greenhouse Plants Medtech Seeds In Pittsburgh

ALung CEO Pete DeComo says the start-up's novel Hemolung device might never have seen the light of day if it weren't for the support of the company's local community and, in particular, investment firm Pittsburgh Life Sciences Greenhouse. And ALung isn't the only Pittsburgh medtech firm the Greenhouse is aiding – there are currently 25 device and diagnostics start-ups in its portfolio.

Innovation StartUps and SMEs

Global Device Approvals, Weekly Snapshot: Neurorehab And Menopause

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Among them, a portable neuromodulation device is approved in Canada for traumatic brain injury.

Approvals Innovation
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