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FDA Wrestles With Social Media At Patient Engagement Meeting

US FDA device center's new Patient Engagement Advisory Committee held its second meeting on Nov. 15, focusing on the potential for social media and other patient-generated information to be a source of post-market medical device data.

Post Market Regulation & Studies Medical Device Digital Health

Results Recap: Trial Results Presented At ObesityWeek, AHA, And Veith Meetings

Results Recap is Medtech Insight's exclusive summary of clinical trial results that have been announced or published in the past week, based on information collected by Meddevicetracker. This week's edition, covering the week of Nov. 9 - Nov. 15, includes trial data presented at the Veith symposium Nov. 13 - 17 in New York, the American Heart Association Scientific Sessions in Chicago Nov. 10 - 12, and the ObesityWeek meeting in Nashville Nov. 11 - 15.

Tracking Trials Clinical Trials Cardiovascular

AI-Powered 'Doctor' Adds Fuel To China Digital Health Investment Fire

China’s artificial intelligence-powered health-care ambition takes a new form, a 24-hour health clinic complete with a medicine dispenser that may eventually be coming to a city corner near you. Pharma companies are also continuing to build digital health services in the country as part of the health technology push.

China Artificial Intelligence Digital Health

33-Country Single Market For MDR And IVDR, And Bigger Reach Beyond

More often than not, the new EU Medical Device and IVD Regulations are talked about in the context of the 28 countries of the European Union (including the UK, for now). In reality, the regulations will have a much wider reach and influence, with Australia making particular efforts to align with the EU.

International Europe Medical Device

QUOTED. Nov. 19, 2018. Erik Hansson.

The number of countries to which the EU's MDR and IVDR will apply totals 33. But the regulations will impact many more markets than that, according to Erik Hansson, deputy head of the European Commission unit that oversees medical devices. See what he said here.

Quoted Regulation Policy

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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

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More Funds, New Tech Needed To Diagnose Lyme Disease, US Work Group Says

A US federal working group focusing on tick-borne diseases is recommending more funds from Congress for Lyme disease diagnostic test development. As the number of cases increase, current diagnostics result in too many false positives and negatives, and there is essentially no test to show an infected individual has been cured, the group says.

In Vitro Diagnostics Infectious Diseases Research & Development

UK MHRA Response To Brexit Questions Still Leaves Gaps And Uncertainty For Medtech

As UK Prime Minister Theresa May tries to get her cabinet to accept the draft Brexit agreement between the UK and EU, Medtech Insight looks at the potential confusion for medtech should she fail.

Brexit United Kingdom Medical Device

QUOTED. Nov. 16, 2018. Scott Gottlieb.

US FDA is proposing to amend its regulations to allow an institutional review board to waive or alter informed consent when a clinical investigation "poses no more than minimal risk" to human subjects and includes safeguards to protect their rights and safety. See what agency head Scott Gottlieb said about it here.

Quoted Clinical Trials

QUOTED. Nov. 15, 2018. Beth Weinman.

Beth Weinman, a former enforcement lawyer in US FDA’s Office of Chief Counsel, says "a big payout" is a strong carrot for someone to file a whistleblower complaint against a device-maker. Check out what Weinman says is another top motivator here.

Compliance Enforcement

US FDA Warns Against Using Unapproved Drugs In Implantable Pumps

Regulators say they have found a correlation between patients given pain medication not approved for their specific implantable drug pumps and a higher number of adverse events.

Safety Drug Delivery

US FDA Allows Waiver Of Informed Consent For Clinical Investigations With Minimal Risk

The agency seeks input on the types of qualifying investigations that involve minimal risk. Providing informed consent waivers in these cases, as required by the 21st Century Cures Act, will help advance health-care innovations, FDA says.

Medical Device Clinical Trials

BSI Is Designated In Netherlands, Giving Clients Go-Ahead To Start Transfer Of Certificates

With a high level of uncertainty still surrounding Brexit negotiations,  UK-based notified body BSI can now offer its clients a more certain future by migrating their certificates to BSI Netherlands if they wish.

Medical Device Brexit

Fresh From US FDA's Chief Counsel Office, Beth Weinman Talks Qui Tam And Compliance

Beth Weinman, a former enforcement lawyer in US FDA’s Office of Chief Counsel, recently joined the life sciences and FDA regulatory practice at Ropes & Gray. She spoke with Medtech Insight about whistleblower suits and FDA enforcement priorities.

Compliance Enforcement

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Q3 Recalls Snapshot: Recalled Devices Slide In Third Quarter; Software A Nagging Issue

Good news for the medical device industry: After two record-setting quarters, the number of recalled products and device units fell in the third quarter of 2018. Yet device-makers are still having problems with software, which was the leading cause of recalls in Q3. Check out our Q3 recalls infographic.

Recalls Safety

Fresh From US FDA's Chief Counsel Office, Beth Weinman Talks Qui Tam And Compliance

Beth Weinman, a former enforcement lawyer in US FDA’s Office of Chief Counsel, recently joined the life sciences and FDA regulatory practice at Ropes & Gray. She spoke with Medtech Insight about whistleblower suits and FDA enforcement priorities.

Compliance Enforcement

US FDA Tweaks Direct Marking Rules In UDI Enforcement Delay

FDA’s latest update to Unique Device Identification compliance deadlines says the agency won’t enforce direct marking UDI rules for some existing devices if the UDI can be determined in other ways.

Enforcement Compliance

Commercial Explore this Topic

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Latest Sapien Valve Gets EU Go-Ahead, But Germany Will Have To Wait

Edwards Lifesciences plans a "controlled rollout" of its Sapien 3 Ultra transcatheter heart valve replacement in Europe following the CE mark announced Nov. 16. But a patent dispute with Boston Scientific will prevent Edwards from launching it in Germany.

Approvals Cardiology Intellectual Property

Trial Results Fail To Support Mainstay Medical's Neuromodulation Device

Mainstay Medical says it will move forward with a US PMA application for its ReActiv8 neuromodulation therapy for chronic back pain even though the ReActiv8 clinical trial failed to reach its primary endpoint.

Clinical Trials Neurology

QUOTED. Nov. 14, 2018. Matteo Lai.

Matteo Lai, CEO of a company that makes the first US FDA-cleared seizure-monitoring smart watch, says users don't care much about artificial intelligence or fancy technology. Rather, they simply want the device to be easy to use and to do its job. See what Lai said about it here.

Quoted Innovation

Execs On The Move: Coloplast, EOS, Notal Hire CEOs From The Inside

Promotions bring execs to the top spots at ostomy and wound-care specialist Coloplast AS, imaging solutions and ortho surgical care company EOS Imaging, and ophthalmics AI firm Notal Vision. Those and more recent medtech personnel moves.

Appointments Commercial

QUOTED. Nov. 13, 2018. Avi Fischer.

Abbott Laboratories pointed to success in its electrophysiology device business last quarter, driven by multiple products including the Confirm Rx insertable cardiac arrhythmia monitor, which the firm says is the thinnest in class, and is smartphone-compatible for more direct patient engagement. See what Abbott VP Ari Fischer says about it here.

Quoted Commercial

Q3 Earnings Spotlight: Ortho Firms Show Mixed Results Against US Pricing Pressure

Reported sales and earnings from the publicly traded orthopedics device companies showed mix results during the third quarter of 2018. NuVasive was the star performer in the group while, on the other end of the spectrum, Stryker continued to show strong growth across most its businesses, while Johnson & Johnson's orthopedic device revenue was near flat.</p>

Orthopedics Deals

Market Intel: Apps for Epilepsy, Steps for Health, Meditation Guides, Mouth Labs Cross Digital Divide For Better Health

Startups at the convergence of technology and biomedical innovations showcased compelling innovations at this week's Exponential Medicine conference in San Diego. This article offers a roundup of new devices targeting a wide range of applications from neurology, cardiology, chronic diseases and wellness.

Innovation Analysis

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Device Week, Nov. 15, 2018 – Digital Solutions Of The Future, And Clinical Trial News And Insights

On this week’s podcast, Reed Miller talks to Medtech Insight’s managing editor Marion Webb about digital health technologies of the future, showcased at the Exponential Medicine conference in San Diego, featured in depth in the latest Market Intelligence story. Medtech Insight’s deputy editor Reed Miller introduces Medtech Insight’s new “Tracking Trials” section, which features a list of trials that are starting, ending or finishing enrollment; including the “Results Recap,” a summary of trials that announced results. He also gives an update of key clinical trial news from this week’s American Heart Association meeting in Chicago.

Analysis Commercial Clinical Trials

Global Device Approvals, Weekly Snapshot: Medtronic, Edwards Wins In Europe

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. CE marks for a Medtronic stent graft and Edwards Lifesciences' TAVR update anchor this week's list.

Approvals Innovation

Starts & Stops: Livongo Launches SUGAR Trial Of Connected Meter; Luminor Completes TINTIN Study Of Luminor Balloon

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from Nov. 5 through Nov. 11, including trial announcements from iVascular, Simplify Medical, Livongo Health, and Bio2 Technologies.

Starts & Stops Tracking Trials

Abiomed Touts New Study Results, Potential To Revolutionize Heart-Attack Treatment

Promising new results from a pilot study of Abiomed’s Impella device to reduce damage after myocardial infarction sets the company up to start a pivotal study, which, if successful, could change how patients are treated immediately after an attack.

Clinical Trials Research & Development

QUOTED. Nov. 9, 2018. Pete DeComo.

When ALung Technologies was selected in 2015 by US FDA to participate in the agency's Expedited Access Pathway program for its novel Hemolung device, the firm wasn't necessarily sure what it was getting itself into. See what ALung CEO Pete DeComo said about the pathway – now called the Breakthrough Devices Program – here.

Quoted Respiratory

Global Device Approvals, Weekly Snapshot: Parathyroid Detection, Diabetes Tech

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Two devices to help surgeons performing thyroid surgery made the list, as did several devices in the diabetes space.

Approvals Innovation

QUOTED. Nov. 2, 2018. Harold Safferstein.

With 25 device and diagnostics start-ups in its portfolio, the Pittsburgh Life Sciences Greenhouse aims to establish life-sciences companies in Western Pennsylvania by leveraging the area's top schools and best-in-class medical facilities. See what the Greenhouse's Harold Safferstein said about it here.

Quoted Innovation
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