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Featured Stories


Mexico Simplifies Digital Advertising Guidelines

A recent guidance document from Mexican medical device regulator COFEPRIS simplifies the agency’s recommendations for online promotion of medical devices.

Mexico Advertising, Marketing & Sales Regulation

Start-Up Spotlight: RenovoRx, Delivering More Targeted Chemotherapy With Catheters

Infused with a fresh round of financing led by Boston Scientific, RenovoRx has begun a multicenter Phase 3 study of its dual-balloon infusion catheter to treat pancreatic cancer. The study will randomize therapy to either the RenovoCath System with the drug gemcitabine or to systemic chemotherapy with gemcitabine and Celgene’s drug nab-paclitaxel delivered intravenously. The goal is to extend the current standard-of-care survival period from about one year to over two years.

Cancer Combination Products Innovation

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. 

M & A Deals Artificial Intelligence

QUOTED. June 22, 2018. Amanda Micklus.

Roche bought out Foundation Medicine in full. Check out what Datamonitor Health analyst Amanda Micklus says about how the deal fits with Roche's current M&A strategy.

M & A Quoted Commercial

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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

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

Bills Calling For Non-Pharma Alternatives To Opioids Clear US House

Several bills that try to lift barriers to development and use of device alternatives for pain management in response to the opioid crisis were recently approved by the US House.

Legislation Policy

Discontinued Endologix AAA Graft Device Singled Out In Updated FDA Alert

US FDA says that previously identified elevated risks of type III endoleaks from endovascular aneurysm repair systems appears to be linked to a specific, no-longer-sold device, Endogix's AFX with Strata system.

Safety Regulation

QUOTED. June 21, 2018. Bassil Akra.

There is confusion over whether it is appropriate for notified bodies to conduct “mock audits” in advance of the new EU Medical Device Regulations. Notified body executive Bassil Akra explains one reason why they can be very helpful here.

Quoted 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 mandate registration with FDA and reporting requirements for third-party servicers of devices, an equipment servicing company said a major downside of H.R. 2112 would be the burdens of having to register with both his business' home state and the federal agency, and that his firm and others already report adverse events to FDA.

Regulation Legislation

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 the program. The agency has also refined how it will conduct appraisals.

Regulation Digital Health

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

Set Alert for Commercial

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 Commercial

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

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

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

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

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

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

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
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