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Market Intel: Promising Data At ATS2018 Inflate Hopes For Endobronchial Valves And New Device-Based COPD Therapies

Chronic obstructive pulmonary disease (COPD) is a widespread, progressive lung disease for which pulmonologists in the US have had few new treatment options available outside the standard pharmacological therapies, lung rehabilitation and high-risk lung volume reduction surgery. Now emerging technologies, in particular, endobronchial valves, which aim to shrink hyperinflated lungs in severe emphysema patients, could soon become the first minimally invasive treatment option available in the US. New study results, presented at this year's annual American Thoracic Society International Conference in San Diego, helped built momentum among US-based clinicians to extend upon their therapeutic arsenal for patients for devices that have already been widely used in Europe. This article discusses study findings presented at ATS, including a new cost-comparison analysis for treating COPD patients at home using non-invasive ventilation and oxygen therapy. We'll also discuss the latest innovative technologies for COPD patients presented at ATS and provide insights from leading experts on factors they think will drive treatment options forward.

Respiratory Commercial Market Intelligence

US Trade Rep Cuts 22 China-Made Devices From Tariffs List, But Retains 27

While the Trump administration appears to have been partially persuaded by industry arguments that a host of China-made medtech items do not belong on a list of items earmarked for a 25% tariff starting July 6, there are still 27 devices – or accessories – that remain.

Trade Policy China

Money Talks Louder To Sirtex As Varian Gets Ditched

Sirtex Medical has accepted the acquisition bid from the owners of CDH Genetech for Aus $33.60 per share, or $1.41bn, that was first announced in May. In January, Varian signed a deal to acquire Sirtex for Aus$28 per share ($1.28bn), but decided not to match CDH's bid, and Sirtex's board decided the higher sale price was worth the additional uncertainties that come with accepting the offer.

Commercial M & A Deals

FDA Panel: Benefits Unproven For BTG Emphysema Treatment

An US FDA advisory panel wasn't convinced by data for BTG/PneumRX’s Elevair Endobronchial Coil System during a June 14 meeting. The panel decided that while the emphysema device was reasonably safe, the sponsor hadn’t shown it was effective or that the benefits outweighed the risks.

Advisory Committees Respiratory FDA

QUOTED. June 18, 2018. Meilan Han.

Pulmonologist Meilan Han says results from the Liberate study – the first randomized controlled trial in the US to evaluate the effectiveness and safety of Pulmonx's Zephyr endobronchial valve in patients with severe emphysema – was exciting in that the amount of improvement amongst patients was clinically significant. Check out what she said about it here.

Quoted Commercial Market Intelligence

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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

Policy & Regulation Explore this Topic

Set Alert for Policy

India Establishes Five Central Testing Labs Under New Medtech Rules

Five central medical device testing laboratories have been established in India under provisions of the country's new medtech regulations.

Policy & Regulation India Medical Device

Compliance Corner: Contract Sterilization Can Be The Bane Of Device-Makers. FDA's Device Expert Sees These 6 Issues

US FDA's Phil Pontikos highlights six problem areas related to contract sterilization that agency investigators routinely see when inspecting manufacturing facilities, from aging facilities to troublesome personnel, and more.

Compliance Corner FDA Compliance

IVDs Are Hitting An Adoption 'Glass Ceiling' While A £7Bn UK Opportunity Goes Begging

Diagnostics should be funded in a way that recognizes the value they bring. The UK IVD industry should also have a seat on the newly-formed Life Sciences Council. These are just two changes that would help diagnostics break through the adoption barrier in the UK and help the health-care system save "billions," say manufacturers.

United Kingdom Reimbursement

US FDA Encourages Broader Use of Popular IVD Coding Standard, Cautions Off-Label Use

Three years after recognizing a widely used coding standard for in vitro diagnostics, FDA appears to be encouraging broader adoption of the codes. It issued a guidance on when it will accept the codes while cautioning against their use for unapproved or uncleared uses.
Regulation In Vitro Diagnostics

Medicaid Targeting Telemedicine To Address Opioid Crisis

CMS sent guidance to state Medicaid directors on how to leverage federal funding authorities for telehealth counseling and gain reimbursement for remote monitoring programs to aid beneficiaries struggling with opioid substance abuse.

Reimbursement Policy

QUOTED. June 15, 2018. Riccardo Fruscalzo.

There are multiple barriers to personalized medicine development in the EU, including misaligned reimbursement policies between drugs and devices. See what attorney Riccardo Fruscalzo says about it here.

Quoted Personalized Medicine

More Safety Tips For LivaNova's Heater-Cooler

In another safety communication from US FDA on LivaNova's Stockert 3T Heater-Cooler Systems, the agency adds recommendations for providers and patients to mitigate the risk of infection from the devices used during open-chest surgery.

Regulation Safety

Guidewire, Catheter Draft Guidance Docs Address Coating Risks

US FDA issued two draft guidelines June 14 addressing labeling and performance testing for guidewires and other interventional vascular devices. The draft recommendations address risks that have been identified in recent years resulting from the separation of coating material from the devices during deployment.

Cardiology Safety

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

As Device Recalls Hit The Stratosphere, FDA Asks Firms To Keep A Sharp Eye On Quality Systems

The US agency's national device expert is urging device-makers to take a hard look at their quality systems in the wake of a product recall. Phil Pontikos says firms must ask themselves "what broke down in your quality system to allow that to happen." His comments come as FDA grapples with an ever-increasing number of corrections and removals from device companies.

Recalls FDA

Compliance Corner: Keep These 5 Supplier Control Tips In Mind, FDA Officials Say

From cautioning against relying too heavily on a vendor's Certificates of Analysis, to advocating for more robust supplier audits, two US FDA investigators and the agency's national device expert offer device-makers advice for keeping vendors in line.

Compliance Corner Quality Control

Compliance Corner: FDA Investigator Lists 7 Common Human Factors Problems, Says Usability Is 'Overlooked'

Longtime agency investigator Laureen Geniusz reveals seven usability issues that agency investigators regularly see when inspecting medical device manufacturing facilities – troubles that could jeopardize patient safety. Her chief concern? "Human factors seems to be overlooked and not fully understood," Geniusz says.

Compliance Corner Safety

Commercial Explore this Topic

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Device Week, June 14, 2018 – Money Matters: Medtech M&A And VC Deal Trends

In this edition of Device Week, Medtech Insight’s Tina Tan and Catherine Longworth discuss this year's trends in M&A and venture fundraising activity. They touch on what areas are getting the most interest from investors and strategic buyers, and the most recent deals worth noting.

Device Week Financing M & A

New AI Tech To Improve AFib Treatment Slated For 2020 Market Launch

Marseille-based Volta Medical is targeting a 2020 release for its AI software to guide cardiologists through atrial fibrillation (AF) procedures. The start-up has recently published data demonstrating the potential of its technology.

Artificial Intelligence Commercial

Medtech Money Flow: Weekly M&A And VC Deals, June 11-17 2018

In this weekly feature, Medtech Insight presents a roundup of the previous week's M&A deals and venture financing rounds recorded in our M&A and VC Deal Trackers. This edition presents the transactions announced June 4-10, 2018.
Commercial Deals

Medtech Multinationals And Turkey's Electronics Giants Tackle Big Tender Offer

With the Turkish government soon to put up for grabs a significant contract for the supply of tens of thousands of advanced imaging and monitoring devices, medtech multinationals are teaming up with local manufacturing heavyweights to up their chances of winning this tender.

Turkey Diagnostic Imaging

Stryker Says It's Not Chasing Boston Scientific

Rumors of a potential Stryker-Boston Scientific coupling have been quashed after the orthopedics player officially stated it is not in discussions with the cardiology company.

Orthopedics Cardiology

Appeals Court Reverses Dismissal Of Brazilian Bribery Allegations Against Stryker

A trade group’s case alleging Stryker bribed doctors in Brazil has been remanded to the trial court after its dismissal was overturned on appeal. The Sixth Circuit said Stryker hadn’t proven that the case should be heard in Brazil.

Brazil Legal Issues

9 + 11 = Possible 3: Can A Stryker-Boston Scientific Combo Work?

Unconfirmed rumors of Stryker having approached Boston Scientific about a takeover bid raised eyebrows all around, not least because the move – reported on June 11 – was so unexpected. But would a combination of the medtech industry's No. 9 and No. 11, to create a broad-scale portfolio with very little product overlap, make strategic sense? Reactions have been mixed.

M & A Orthopedics

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Procept BioRobotics Believes Aquablation Could Dominate BPH Treatment…If It Gets Coverage

Results of the WATER II trial confirm that Aquablation is a safe and effective treatment of benign prostate hyperplasia for large prostates, and manufacturer Procept BioRobotics is confident the procedure will eventually displace all other prostate resection techniques because it is easy for surgeons to learn.

Research & Development Gynecology & Urology Innovation

QUOTED. June 13, 2018. Nikolai Aljuri.

Procept BioRobotics is seeking a unique Category I CPT code that would make it possible for its AquaBeam Aquablation device to be reimbursed at a higher rate than older prostate resection techniques. See what company founder and CEO Nikolai Aljuri said about it here.

Quoted Research & Development

Starts & Stops: June 4-10, 2018

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made between June 4-10, 2018, including announcements from Medtronic, MicroPort, NovoCure, and Theraclion.

Starts & Stops Clinical Trials

Global Device Approvals, Weekly Snapshot: June 4-10, 2018

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.

Approvals Innovation

New NEST Subcommittees Include Industry

Medtronic, Cook, BD and J&J are represented, along with academic and US FDA officials, on two new subcommittees formed by the National Evaluation System for health Technology Coordinating Center, which is establishing real-world evidence networks for medical devices.

Clinical Trials Regulation

QUOTED. June 7, 2018. Richard Trimlett.

Sutrue Ltd. says it's working on an robotic/endoscopic suturing device that will make surgeries easier, with quicker recoveries. The current standard of care is not ideal, cardiologist Richard Trimlett, who works with the company, emphasizes here.

Innovation Clinical Trials

QUOTED. June 6, 2018. Geoffrey Oxnard.

Clinical results from the Circulating Cell-free Genome Atlas (CCGA) trial that were presented at the American Society of Clinical Oncology Annual Meeting are positive for Grail Inc.'s genome-sequencing blood-tests. See what trial investigator Geoffrey Oxnard had to say about the findings here.

Clinical Trials In Vitro Diagnostics