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Mock Audits: Has Ambiguity In EU Led To Unfair Advantage?

There's been confusion and conflicting opinions about notified bodies conducting mock audits on companies' documentation to prove conformity with the impending EU Medical Device and IVD Regulations. Has the lack of clarity led to different and unfair practices? Does it matter?

Medical Device Europe Compliance

SOPHiA Buys In More Bioinformatics Know-How For Cancer Genomics

In a move to accelerate adoption of its AI-driven genomics platform, SOPHiA Genetics has acquired Interactive Biosoftware, the French developer of Alamut, a clinical decision support software used in  genomic data interpretation. 

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

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

Turkey Diagnostic Imaging Commercial

Size Doesn't Matter: US FDA Refines Dig-Health Pre-Cert Model

After receiving feedback from industry and other stakeholders, FDA has revised its "working model" for its planned pre-certification program for health software. It now states that size of a company will not preclude them from participating in its. The agency has also refined how it will conduct appraisals.

QUOTED. June 20, 2018. Hugh Cassiere.

BTG ran into some serious scrutiny of its Elevair coil system for emphysema from an FDA advisory committee, which wasn't convinced the device offered a benefit that's worth the its risks. Check how physician and panel member Hugh Cassiere summarized the group's findings here.

Advisory Committees Commercial Quoted

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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

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Darzi Takes Witty's Seat At UK Innovation Group, As Brexit Heats Up And NHS Adds Ambiguity

The UK's Accelerated Access Collaborative (AAC) has filled the hole left by ex-Glaxo CEO Andrew Witty's recent departure with public-sector stalwart Lord Ara Darzi. This should restore some certainty to the initiative when the UK health-care sector was thrown into confusion by the promise of £20bn more NHS funding and by ongoing Brexit machinations with uncertain impact.

United Kingdom Innovation Market Access

UK Regulator Adds Symptom-Checkers To Software/App Guidance

The Medicines and Healthcare products Regulatory Agency explains which symptom checkers are likely to be medical devices.

United Kingdom Policy & Regulation Europe

Q&A: Ongoing Mishaps From Bad Device Fixes Argue For Third-Party Servicing Bill, Bayer Exec Says

In an interview with Medtech Insight, Bayer executive Dennis Dermis described some near-misses to patient safety involving shoddy repairs to his firm's devices. The incidents convinced him that Congress needs to pass legislation requiring all third-party servicers to register with US FDA and report adverse events to the agency.

Regulation Quality

Servicing Company Points To Downsides In Third-Party Servicing Bill

At a recent industry briefing to educate US congressional members about proposed legislation to require third-party servicers of devices to register with FDA, an equipment servicing company said a major downside is that registration with the agency is too costly, and that his firm and others already report adverse events to FDA.

Regulation Legislation

Warning Letter Roundup & Recap – June 19, 2018

No device-related warning letters were released by US FDA the week of June 12.

Device Warning Letters FDA

QUOTED. June 19, 2018. Doris-Ann Williams.

The UK IVD industry is pushing for better recognition of the value that lab tests can bring to the country's health-care system, including, for instance, in helping reduce antibiotic resistance. See what British In Vitro Diagnostic Association's Doris-Ann Williams has to say about industry's challenge here.

Reimbursement In Vitro Diagnostics

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 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

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

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

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

Commercial Explore this Topic

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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 M & A

Roche Pushes Personalization With $2.4Bn Foundation Buy-Out

By picking up the rest of Foundation Medicine, which is now valued at $5.3bn, the Swiss giant is expanding its leadership in cancer diagnostics, genomics and molecular information for personal medicine.

M & A Digital Health

Patent Office Judge Suing Medtronic For Wrongful Termination

US Patent Trial & Appeals Board Chief Judge David Ruschke has filed a wrongful termination suit against former employer Medtronic. Ruschke alleges Medtronic dismissed him due to his sexual orientation and a medical condition. The company denies the allegations.

Legal Issues Commercial

Physician Suit Alleges Stryker Sold Uncleared Surgical Tool

A proposed class action suit in California alleges that Stryker distributed surgical tools that did not have appropriate FDA clearance. 
Medical Device Legal Issues

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

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

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

Clinical R&D Explore this Topic

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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 Companies

Global Device Approvals, Weekly Snapshot: June 11-17, 2018

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

Approvals 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

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

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