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Featured Stories


US FDA Gives It’s Two-Cents On Nickel-Titanium Alloys

Nitinol, a nickel-titanium alloy ubiquitous in medical devices, is getting more scrutiny from US FDA in a recently released draft guidance. As safety concerns have arisen in the past few years over biocompatibility of certain materials in implanted products, the agency is asking device makers to provide additional information on nitinol in their device submissions.

Regulation Advisory Committees Approvals

Global Device Approvals Snapshot: April 16-22, 2019

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved BaroNova's TransPyloric Shuttle and its delivery system to treat obesity. It also cleared NeuroSigma’s Monarch external trigeminal nerve stimulation system, making it the first FDA-approved device for treating attention deficit hyperactivity disorder.

Approvals Clinical Trials Research & Development

Market Brief: Global Market for Arthroscopy And Sports Medicine Products Will Reach $9Bn By 2023

The global market for arthroscopy products and sports medicine implants is expected to reach $9.0bn by 2023, a CAGR of 4.2% from $7.3bn in 2018, driven in part by the rising availability of arthroscopy at ambulatory surgery centers in many countries, expanding indications for arthroscopic repair, patient preference for minimally invasive procedures and advanced techniques.

Orthopedics Innovation Surgical Procedures

NeuroSigma Monarch eTNS Becomes The First FDA-Cleared ADHD Device

The de novo clearance is based on the results of a 62-patient phase II sham-controlled trial. Patients in the treatment group showed more improvement in attention deficit hyperactivity disorder symptoms over four weeks than patients treated with a placebo device.

Approvals Clinical Trials Neurology

FDA Panel To Address Paclitaxel Safety Concerns

The US FDA will soon hold a meeting to discuss paclitaxel-coated devices to treat peripheral arterial disease. The drug-eluting stents and balloons have been subject to increased scrutiny since a meta-analysis found they were linked to a higher patient mortality rate.

United States Advisory Committees FDA

QUOTED. April 22, 2019. Frans van Houten.

Philips' CEO Frans van Houten spoke about his vision for the company's continued adoption of machine learning and artificial intelligence at the World Medical Innovation Forum in Boston. See what van Houten said about it here.

Quoted Business Strategies Artificial Intelligence

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Policy & Regulation Explore this Topic

Set Alert for Policy

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

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

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

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

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

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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

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

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

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

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

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

BaroNova’s TransPyloric Shuttle Earns FDA-Approval To Treat Obesity

Patients treated with the TransPyloric Shuttle in the 213-patient ENDObesity II trial lost an average of 9.5% of their body-weight and 30.9% of their excess weight.

Approvals Clinical Trials Gastroenterology

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

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

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

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

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
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