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Proposed 510(k) Changes Elicit Some Industry Skepticism

Two 510(k) pilots from US FDA indicate the agency's desire for faster, easier clearances. But some observers aren’t sure if they’ll lead to real improvements.

Regulation Medical Device United States

US FDA Shelves Proposal To Mandate Home-Use Device E-Labeling

A controversial 2016 proposed rule that would have required manufacturers of many class II and class III home-use devices to electronically submit device labeling information to US FDA will not be finalized, the agency affirmed in the Oct. 17 HHS Unified Agenda document. The agency also signaled plans to imminently finalize a broad device classification rule, and other updates.

Regulation Medical Device United States

Philips Goes Fishing For Start-Ups With Healthtech AI Ambitions

Royal Philips has launched a global artificial intelligence collaboration program with start-up companies that will allow innovators in the area to work with the group's global innovation hubs. The company is looking to build and scale promising ideas and consider them for further collaboration.

Digital Health Artificial Intelligence Deals

Apple And Zimmer Biomet To Study Patient Experience With Joint Replacement Surgery

The study will evaluate Zimmer Biomet's mymobility app on the Apple Watch and iPhone to guide patients undergoing knee or hip surgery through both pre- and post-op care.

Clinical Trials Digital Health Orthopedics

QUOTED. Oct. 17, 2018. Ian Crosbie.

Significant market adoption of Sequana Medica's pump targeting fluid build-up that is linked to liver cirrhosis will depend on the company's ability to reach beyond patients with alcohol-related liver diseases to those with"non-alchoholic steatohepatitis," or NASH, the firm's CEO explains here.

Quoted Financing Liver & Hepatic

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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

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Policy & Regulation Explore this Topic

Set Alert for Policy

Australia Requires Patient Cards With All New Implants From Dec. 1

Requirements relating to patient cards and information leaflets for all implantable medical devices are based on the new EU medtech rules, but Australia has chosen to implement these earlier to address consumer information gaps.
Australia Policy & Regulation Safety

Alzheimer's Is A Repeat Target For FDA Breakthrough Device Path

NeuroDiagnostics LLC said its investigational Alzheimer's disease test had been designated by US FDA as a Breakthrough Device. This is at least the third company to achieve that recognition for technology targeting Alzheimer's this year.

Neurology In Vitro Diagnostics Regulation

Warning Letter Roundup & Recap – Oct. 17, 2018

No device-related warning letters were released by US FDA the week of Oct. 17.

Device Warning Letters FDA

CMS Will Assess Add-On Pay Candidates In December

The US Centers for Medicare and Medicaid Services will hold a town hall in early December to discuss FY 2020 applications for new add-on payments for technologies under the hospital inpatient prospective payment system.

Reimbursement Regulation

What Should You Be Earning? Salary Benchmarks And Hiring Trends In Regulatory Affairs

The latest compensation survey by the Regulatory Affairs Professionals Society provides some salary benchmarks, as well as data on factors influencing the job market globally, and other noteworthy stats on the sector.

Regulation Medical Device

Device Week, Oct. 12, 2018 – US Midterm Elections: What’s At Stake For Medtech?

Medtech Insight senior reporters Ferdous Al-Faruque and Sue Darcey talk about how the upcoming US midterm elections could shake things up for the medical device industry in this week’s podcast.

Device Week Elections

QUOTED. Oct. 12, 2018. Deborah Kotz.

US FDA hasn't posted a device-related close-out letter online in five months. Agency spokeswoman Deborah Kotz says firms were "issued" close-outs over the past six months – they just haven't been posted online yet. But a firm being "issued" a close-out letter isn't the same as having FDA publicly announce it online for the world to see – which, one could argue, is the whole reason behind the close-out program in the first place. See what else Kotz said here.

Quoted FDA

Device Industry Champion Erik Paulsen In Tough Election Fight To Retain House Seat

Longtime medtech industry supporter and device tax repeal sponsor Rep. Erik Paulsen, R-Minn., is in a tough political fight against his challenger, businessman Dean Phillips, a Minnesota Democrat who has been publicly chiding Paulsen for helping to push tax reforms through Congress that are viewed as less favorable to the middle class than to corporations.

Elections Legislation

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

FDA Hasn't Publicly Released A Device-Related Close-Out Letter For 5 Months, Defeating Purpose Of Program

Medical device manufacturers under the dark cloud of a US FDA warning letter work hard to close them out, and, importantly, receive a close-out letter from the agency that is posted online for everyone to see. Yet FDA hasn't publicly released such a missive to device companies since May – the longest gap since the close-out program began in 2010. FDA says it's aware of the problem.

FDA Compliance

Device Week, Sept. 21, 2018 – Medtech’s Next Top Maturity Model, Part 4

Medtech Insight’s Shawn M. Schmitt talks about Part 4 of “Medtech’s Next Top Maturity Model,” his feature series on the appraisal of device-makers’ manufacturing capability and maturity. This episode focuses on appraisers affiliated with Pittsburgh's CMMI Institute and describes the hurdles they must clear to be part of a US FDA pilot program that uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) framework.

Device Week Quality Control

Assessing A Device-Maker's Manufacturing Capability Is Serious Business For These 2 Longtime CMMI Appraisers. Here’s Their Story

From training classes to onsite observations, two lead appraisers affiliated with Pittsburgh's CMMI Institute describe the high hurdles they jumped to be part of a flourishing US FDA pilot program that aims to elevate product, manufacturing and process quality at device firms. The pilot uses an industry-tailored version of the tried-and-true Capability Maturity Model Integration (CMMI) framework that's been around for decades. Beth Layman, an appraiser who has assessed more than a hundred companies in a variety of industries, says appraisers can't just be book-smart – rather, they must also possess a select set of personal skills, including flexibility and open-mindedness. Her fellow appraiser Thayne Hill, who "was there in the early days" of the Capability Maturity Model, says device-makers are often leery of appraisers because of past negative interactions with regulators, which can make his job challenging.

The fourth of a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry.

Quality Control FDA

Commercial Explore this Topic

Set Alert for Commercial

Sequana Medical Pumped About NASH's Market Potential

Following a fresh injection of funding, Sequana Medical is gearing up to grow its European business and begin a pivotal US study for alfapump, its implantable, automated pump for the continual removal of ascites. The Belgian company is positioning itself as a key player in the growing liver disease treatment market.

Financing Liver & Hepatic Growth

Execs On The Move: Promotions At BD, Abbott, LuxCath and Varian Medical

Recent moves up the ladder: new COOs at Beckton Dickinson and Abbott, a chief technology officer at LuxCath, and a chief growth officer at Varian Medical. In addition, the chairman of BTG announced his decision to depart at the end of the year.

Appointments Commercial

Robert Ford Steps Up At Abbott Labs

The company's device business chief is expanding his portfolio as Abbott's new president and chief operating officer, leading to some speculation that he is being positioned to be the next CEO.

Appointments Commercial

Medtech Money Flow: M&A And VC Deals, Oct. 8 - 14, 2018

This edition of Medtech Money Flow rounds up the M&A and venture financing deals, as recorded in our M&A and VC Deal Trackers, between Oct. 8 and Oct. 14. 
M & A Deals

QUOTED. Oct. 15, 2018. Joshua Stowell.

Diagnostic developers may face a narrowing path to get patent protection in the wake of court determinations that "fundamental laws of nature" aren’t patentable. Some legal observers advocate carefully deploying trade secrets to bridge the gap. See what attorney Joshua Stowell said about it here.

Quoted Commercial

In Post-Alice Patent World, Diagnostics Turn To Trade Secrets Protection

Recent legal cases have made some diagnostics unpatentable because they rely on detecting natural phenomenon. An attorney involved in patent law offered Medtech Insight some insight on how developers can use trade secrets to protect their ideas.

Medical Device Diagnostics

Myriad Genetics Signs Marketing Plans With Pfizer For BRACAnalysis CDx Test

Myriad Genetics, Inc. and Pfizer Inc. signed an agreement to promote Myriad's BRACAnalysis CDx test, currently under US FDA review, as a companion diagnostic for Pfizer's investigational breast cancer drug, talazoparib.

M & A Deals

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Temple Hopes To Be Center Of New Medtech Boom In Texas

Temple, Texas, is not the first place that comes to mind as a medtech industry hotspot, but the small city wants to be the anchor of a "medtech triangle" in central Texas. It currently boasts the 5,000-square foot Temple Health and Bioscience District facility with space, equipment, guidance and networking opportunities for medtech start-ups. The hope is it will grow and attract investment and more high-paying jobs.

US States Business Strategies Innovation

Global Device Approvals, Weekly Snapshot: Diabetes Tech In Canada

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Among the four added this week, Tandem Diabetes and Medtronic both gained integrated insulin pump system approvals in Canada.

Approvals Diabetic Care

Starts & Stops: Abbott And Edwards Update TAVR Trials; Enrollment Complete In Medtronic Resolute Onyx High-Risk Trial

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made Oct. 8 through Oct. 14, including trial announcements from Abbott Laboratories, Medtronic, Edwards Lifesciences, Carag AG, DJO Global, RTI Surgical, and Terumo.

Starts & Stops Tracking Trials

Exec Chat: Billy Cohn Talks About His J&J Play In Texas

The surgeon and serial device inventor has been getting Johnson & Johnson's Center for Device Innovation off the ground this year on the vast Texas Medical Center complex, and he says it's like nothing he has ever experienced.

Exec Chat Innovation

Q3 US Device Approvals Snapshot: Apps Up, Original PMAs Down

Mobile apps made major headway into the world of US FDA regulation in the third quarter, with de novo go-aheads for two Apple Watch heart-rhythm apps and the first FDA approval of a smartphone app to support contraception. Meanwhile, original PMA-approval volumes continue to lag in 2018. Here's an infographic to spotlight US device approval trends during the third quarter, July through September.

Approvals FDA

Global Device Approvals, Weekly Snapshot: Seeing And Hearing

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. A smart contact lens, self-fitting hearing aid and laser eye surgery device are among the new additions to the tracker.

Approvals Innovation

Starts & Stops: SPR Lands DOD Grants For Nerve Stimulation To Treat Pain; Epix Completes Trial of DiamondTemp Ablation Device; Apollo Finishes Enrollment Of Orbera Post-Approval Trial

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made Oct. 1 through Oct. 7, including trial announcements from Apollo Endosurgery, SPR Therapeutics, Endologix, and EPIX Therapeutics.

Starts & Stops Tracking Trials
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