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Featured Stories


Lawmakers Worry Chinese Researchers, Shadow Labs, Stealing US Genomic Data

US Senators are speaking-out about the ongoing FBI investigations into Chinese researchers accused of using National Institutes of Health (NIH) genetic testing research and grants and stealing US institutions’ intellectual property to establish “shadow laboratories” in China with access to Americans’ genomic data.

Cybersecurity Politics Intellectual Property

Beyond The Hype: Philips CEO Says The Future Is AI Platforms

Philips CEO Frans von Houten says the future of health care is in AI platforms that will transform how effectively and efficiently patients are treated. He predicts the technology will be so ubiquitous that users will not even realize they are interacting with the technology.

Commercial Artificial Intelligence Business Strategies

Start-Up Spotlight: GT Medical Technologies' GammaTile Brings Brachytherapy Directly To Brain Tumors

Arizona-based GT Medical Technologies is ramping up commercialization of its GammaTile surgically targeted radiation therapy for patients with recurrent intracranial neoplasms. GammaTile already received 510(k) clearance, but continues to develop clinical evidence showing that GammaTile improves control of brain cancer following excision surgery and prolongs patient-survival.

Start-up Spotlight StartUps and SMEs Cancer

Medtronic's Endurant AAA And Valiant Navion SFA Featured At Charing Cross Symposium

Medtronic is encouraged by new data on endovascular repair of abdominal aortic aneurysm presented at the Charing Cross Symposium, including preliminary data from the ANCHOR registry on Endurant used in combination with the Heli-FX Endoanchor system. At the same meeting, 30-day results from 100 patients in the pivotal trial of Valiant Navion thoracic stent graft system showed high rates of procedural success in patients with a thoracic aortic aneurysm and penetrating atherosclerotic ulcer.

Clinical Trials Cardiovascular Innovation

Medtronic’s VenaSeal Proves Durable In Five-Year Results

Five-year outcomes from the VeClose Extension Study at the 2019 Charing Cross Symposium in London show the aggregate complete closure rate of the great saphenous vein was 94.6% in chronic venous disease patients treated with VenaSeal.

Clinical Trials Cardiovascular Innovation

QUOTED. April 18, 2019. Cameron Piron.

At this year's annual American Association of Neurological Surgeons (AANS) conference, medical device makers demoed high-tech digital solutions for neurosurgeons. See what Synaptive Medical's president, Cameron Piron, said about its surgical planning software.

Quoted Neurology Innovation

Latest from PR Newswire

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Recent Tweets from Medtech Insight


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Policy & Regulation Explore this Topic

Set Alert for Policy

J&J Cleared In Philly Pelvic Mesh Trial

Product liability cases alleging manufacturers of pelvic mesh are responsible for patient injuries continued even as the US FDA is halting sales of the product. In the most recent verdict, a Philadelphia jury said Johnson & Johnson was not responsible for adverse events experienced by a Pennsylvania woman.

Legal Issues Safety Gynecology & Urology

Podcast: Philips CEO On Future Of AI, Health Care Systems

Philips CEO Frans von Houten sat down with Medtech Insight for an exclusive chat on the company’s philosophy for artificial intelligence and what is needed to fully embrace the technology as health care systems evolve.
Artificial Intelligence Business Strategies

Making Sense Of The Muddle Of EU Device Registration Timelines

The recent document from the European Commission's Medical Devices Coordination Group concerning device registration timelines is difficult to follow, with its many unexplained references. This article aims to clarify how the MDCG's findings affect the way manufacturers should prepare for MDR compliance.

EU Regulation

Device Week, April 17, 2019 – Safety Under Spotlight After Mesh Pulled From US Market, Pediatric Air Tubes Run Short

In this week's Medtech Insight podcast, Shawn M. Schmitt explains why the FDA ordered transvaginal mesh products removed from the US market, and Ferdous Al-Faruque highlights a growing device-shortage issue linked to problems at two US sterilization facilities.

Device Week FDA

WHO Consults On Remaining Shelf-Life Policy For Medical Products

The World Health Organization has framed a policy to help suppliers, donors, procurers and distributors manage medical products throughout the supply chain and ensure availability within their remaining shelf-life.

International Regulation

Commission Told New EU Regulation ‘Clearly Untenable’ And ‘Not Ready To Function’

With just over 13 months until the EU Medical Devices Regulation is fully applicable, EU medtech manufacturers are imploring the European Commission to speed readiness of the new regulatory system or patients and industry will suffer.

EU Regulation

'Full-Speed Ahead,' Says Acting US FDA Chief Sharpless

In his first speech to agency staff, US FDA acting Commissioner Ned Sharpless says the agency will continue working on issues such as the Medical Device Safety Action Plan, the precertification program and the National Evaluation System for health Technology (NEST). He also says he's not approaching the post like a temporary caretaker.

FDA Leadership

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

WHO Consults On Remaining Shelf-Life Policy For Medical Products

The World Health Organization has framed a policy to help suppliers, donors, procurers and distributors manage medical products throughout the supply chain and ensure availability within their remaining shelf-life.

International Regulation

QUOTED. April 15, 2019. Luann Pendy.

Medtronic quality VP Luann Pendy worked with the US FDA and the Medical Device Innovation Consortium through its joint Case for Quality devise a so-called "#makeCAPAcool" initiative to recast corrective and preventive action as a continuous learning tool. See what Pendy said about the "monster called CAPA" here.

Quoted Quality

How A Team Led By Medtronic Quality Experts Plans To Stand Up To 'A Monster Called CAPA' – And Make It 'Cool'

The so-called "#makeCAPAcool" group wants to recast corrective and preventive action as a continuous learning tool, rather than a place where problems often go to linger, be ignored and never die. A new voluntary CAPA framework developed by the team and piloted by a handful of device-makers will be rolled out later this year.

Quality Control Manufacturing

Commercial Explore this Topic

Set Alert for Commercial

Market Intel: #AANS2019: High-Tech Microscope Technologies Illuminate Brains, Spines

This year's annual American Association of Neurological Surgeons conference offered neurosurgeons and allied health professionals five days of clinical trial news, seminars and live-streaming videos to learn about the latest developments in their field. Medtech Insight had an ear close to the ground, posting Tweets on some of the latest technologies, including robotic-assisted microscopes, showcased by exhibiting companies. Here is a round-up of the best of the Tweets and updates from company executives.

Neurology Innovation Market Intelligence

Podcast: Philips CEO On Future Of AI, Health Care Systems

Philips CEO Frans von Houten sat down with Medtech Insight for an exclusive chat on the company’s philosophy for artificial intelligence and what is needed to fully embrace the technology as health care systems evolve.
Artificial Intelligence Business Strategies

QUOTED. April 19, 2019. Matt Likens.

GT Medical Technologies Inc. launched GammaTile permanent intracranial brachytherapy device, designed to be placed in the space left after the excision of a brain tumor. See what GT Medical Technologies' CEO and president Matt Likens said about it here.

Quoted Start-up Spotlight

AngioDynamics Off-Loads Namic Fluid-Management Business To Medline

Medline Industries will pay $167.5m for the Namic brand of manifolds, contrast management systems, closed fluid systems, guidewires, disposable transducers and interventional accessories. It also includes a manufacturing facility and the manufacturing, sales and marketing staff that support Namic.

 
Deals M & A

Execs On The Move: Promotions At Midmark And Episurf Medical; Akili Welcomes Finance Leader

Medical products firm Midmark Corp. names a new VP of Corporate Accounts; ortho implant-maker Episurf Medical designates a COO; digital-medicine developer Akili Interactive Labs hires a new CFO; and more.

Appointments Commercial

QuantumMDx And Glaxo Smith Kline Partner On QC Analyzer For Cell And Gene Therapies

QuantumMDx Group Ltd has signed a deal with GlaxoSmithKline to co-develop a quality control analytics system for cell and gene therapies.

Commercial Companies

Two Dozen Charged In $1.2Bn DME Telemarketing Fraud

Two dozen telemedicine executives, durable medical equipment vendors and health-care providers have been indicted as part of what the US Department of Justice calls “one of the largest health-care fraud schemes” in recent years.

United States Commercial

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Guardant360 Lung-Cancer Assay Beats Tissue Genotyping In NILE

New trial results show Guardant Health's Guardant360 largest cell-free DNA assay rapidly identifies biomarkers for metastatic non-small cell lung cancer associated with specific therapies at least as accurately as standard-of-care tissue genotyping.

Clinical Trials Cancer In Vitro Diagnostics

Pivotal Results Show MicroVention’s WEB Treats Challenging Brain Aneurysms

The Woven EndoBridge (WEB) aneurysm embolization system proved relatively safe and effective in the 150-patient WEB-IT trial. The trial results are now published in the Journal of Neurointerventional Surgery.

Clinical Trials Innovation

Pivotal Trial Of Carmat’s Total Artificial Heart Delayed

Carmat suspended the production of its Total Artificial Heart while it strengthens certain manufacturing processes.

Research & Development Clinical Trials

Gelesis's Plenity Obesity Product Earns De Novo For Wide BMI Range

PureTech's affiliate Gelesis has received US FDA de novo clearance for its Plenity capsule to treat overweight-obese adults, and plans to launch it commercially in the second half.

Approvals Research & Development

Global Device Approvals Snapshot: April 9-15, 2019

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved Qiagen's therascreen FGFR RGQ RT-PCR companion diagnostic for Janssen's new drug to treat specific types of urothelial cancer and Intact Vascular's Tack device to treat dissections of the above-the-knee peripheral arteries following angioplasty.

Research & Development Approvals

Intact Vascular’s Tack Peripheral Dissection Repair Device Earns PMA

The approval of the Intact's peripheral artery dissection repair device is based on results from the 213-patient TOBA II trial, which showed Tack resolved 92.1% of dissections in peripheral arteries following balloon angioplasty.

Research & Development Clinical Trials

FDA Approves Qiagen’s Therascreen Urothelial Cancer Companion Diagnostic

The Therascreen FGFR kit helps identify urothelial tumors with alterations to the fibroblast growth factor receptor 3 gene that indicate the cancer will respond to Janssen’s new drug Balversa.

Research & Development Approvals
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