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Device-Makers Can Be 'Recall Ready' With This New Step-By-Step Guidance From FDA

From general preparations to the development of correction and removal initiation procedures, the US agency is offering recommendations to firms on how to recall a problem product. In its new draft guidance, the FDA says it's "critical" for manufacturers to be "recall ready."

Recalls FDA Guidance Documents

Crossing The 'Valley Of Death': Breakthrough Devices Rule Could Lead To Slew Of New Products

A new proposed rule would give automatic new technology add-on payments to breakthrough devices. While it may affect only a very small sector of the industry, the lobby group AdvaMed says it is a good first step to getting broader coverage for all devices and will incentivize companies to invest in breakthrough device research.

Regulation Approvals Government Payers

UK Turns To Israel For More Medtech Innovation

The UK device industry’s interest in Israel's start-ups is growing in the wake of Brexit, with more tech partnerships between the two countries. Medtech Insight met with the UK Israel Tech Hub, based in Tel-Aviv, which has helped facilitate business between Israeli medtech companies and UK.

Israel Innovation Market Access

Boston Scientific Becomes Third US TAVR Competitor With Lotus Edge Approval

The US FDA approved Boston Scientific's Lotus Edge transcatheter aortic valve for patients who would be at high risk with surgical valve replacement. Unlike competing TAVR systems from Medtronic and Edwards, Lotus Edge can be repositioned or recaptured after it has been deployed.

Approvals Innovation Cardiovascular

QUOTED. April 25, 2019. Ayelet Mavor.

The UK Israel Tech Hub works with UK companies and the NHS to understand their innovation needs and how they can be solved with technology, and then scout for solutions on the ground in Israel. See what the Hub's Ayelet Mavor said about it here.

Innovation Market Access Brexit

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Policy & Regulation Explore this Topic

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Thousands Of Deaths, Serious Injuries Spur Surgical Stapler Reg Proposals

Prompted by more than 41,000 adverse events tied to surgical staplers in less than a decade, the US FDA issued a draft guidance document on the devices and proposed an upclassification from class I to class II. The measures are to be discussed at a May advisory committee meeting.

FDA Regulation Guidance Documents

Sharp Rise In EU MDR Notified Body Applicants Is Pleasant Surprise

The number of EU notified bodies applying for designation against the EU MDR has risen by over a third in the past nine months, the European Commission reports. IVDR applicant numbers are up slightly too. But are the increases enough to ease the anticipated bottlenecks?

EU Regulation Medical Device

Breakthrough Devices To Get Special US Medicare Reimbursement Under CMS Proposal

The US Centers for Medicare and Medicaid Services plans to automatically allow reimbursement and up to 65% new technology add-on payments for US FDA-approved, -cleared or de novo devices in the agency's Breakthrough Devices Program. Industry groups, including the Medical Device Manufacturers Association and AdvaMed, have been pushing CMS for such coverage for several years.

Reimbursement Medicare

Warning Letter Roundup & Recap – April 23, 2019

No device-related warning letters were released by the US FDA the week of April 23.

Device Warning Letters FDA

Cambodia's ‘Fragmented’ Regulatory Rules To Be Overhauled

Cambodia’s regulatory framework needs an overhaul, according to the World Health Organization, which has issued a tender for interested parties to review the current situation and produce draft legislation that meets current international norms.

Cambodia Regulation

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

QUOTED. April 23, 2019. Sen. Roy Blunt.

US legislators accuse the Chinese government of recruiting and subsidizing US NIH-funded Chinese researchers to steal US-owned genetic research and intellectual property, cheating the peer review system, and establishing US-connected lab facilities with access to US citizens' genomic data. See what US Senator Roy Blunt said about it here.

Quoted Cybersecurity

US FDA Gives Its 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

Quality Control & Compliance Explore this Topic

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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

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

With Fresh Guidance, US FDA Aims For Consistency In Device Facility Inspections

A new draft guidance document from the agency says domestic inspections should occur over a brisk three to six consecutive days, alleviating a pain point for device firms that say some agency investigators traipse in and out of an audit, sometimes causing inspections to drag on for weeks.

FDA Guidance Documents

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Execs On The Move: Tech, Sales Changes At GlobalMed And Alphatec; New Board At Sensei Biotherapeutics

Microsoft tech director now CTO of telemed firm GlobalMed; spinal fusion technology developer Alphatec gets a new EVP of Sales; cancer-therapy experts join new Advisory Board of precision-medicine company Sensei Biotherapeutics; and more.

Appointments Commercial Medical Device

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

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

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

Listen: Philips CEO On Future Of AI, Health-Care Systems

Philips CEO Frans von Houten sat down with Medtech Insight for an exclusive podcast 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

Clinical R&D Explore this Topic

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Axogen Expands RECON Study Of Avance Nerve Graft

The study will be expanded by 50 patients, for a total of 220 subjects, based on the recommendation of a statistician who reviewed an interim analysis. RECON is intended to support a Biologic License Application for Avance, a processed human nerve allograft for bridging severed peripheral nerves.

Clinical Trials Starts & Stops Neurology

SurModics Resumes TRANSCEND Trial Of SurVeil Drug-Coated Balloon

SurModics suspended the trial with their SurVeil drug-coated balloon in March after the US FDA sent a letter to physicians alerting them to possible safety problem with paclitaxel-coated devices. The company has updated the patient consent form and established a new patient follow-up program for the trial.

Clinical Trials Cardiovascular

MD Anderson Cancer Center Kicks Out Chinese Researchers Following NIH Grant Inquiries

Investigations into violations of National Institutes of Health grant-funding rules targeting scientists from China and other countries working on genomic research have already resulted in three firings at a famous cancer center in Houston.

Enforcement Intellectual Property

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

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

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

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
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