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Market Intel: Cornea, Bio-Drugs, Artificial Hips On Track For 3D Printing

Although certainly not a given, many researchers and companies are pursing the eventual goal of bioprinting human organs, starting with the three-dimensional printing of a structure that has cellular function. If organ function via bioprinting becomes a reality for the skin, bone, lung, liver, eye and/or kidney, among other potential organs, the market opportunity could be in the billions. But challenges, including cost and ethics, stand in the way of this milestone in regenerative medicine.

Regenerative Medicine Market Intelligence Innovation

Boston Scientific Agrees To Pay $4.2Bn For UK Interventional Oncology Firm BTG

A busy year of M&A for Boston Scientific just got busier with a $4.2bn cash offer for UK interventional medicine specialist BTG. Completion is expected by mid-year 2019.

M & A Business Strategies Cancer

FDA Looks To Lead World In Post-Market Device Surveillance With Safety Plan, Investments

US FDA Nov. 20 announced plans for a broad series of updates to its Medical Device Safety Action Plan for the next several months, with the goal that FDA "is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.

Safety Post Market Regulation & Studies Regulation

'Where Technology Meets Science': Doctors, Medical Students Take Experimental Medtech For A Spin In Pittsburgh's Center For Surgical Arts

Some big-name device-makers – Medtronic, Stryker, Karl Storz, Siemens and more – are donating expensive capital equipment to the Center for Surgical Arts, a modern teaching lab that boasts 21 bays for training residents and fellows in various types of surgery. The companies are doing this to not only nail down future customers, but to test new devices, as well. The Center also includes a Bose test frame that was used to help clear Alphatec Spine's Solus device with US FDA without a clinical trial. "Those can be multimillion-dollar studies. So, to be able to do that, and to have the FDA feel comfortable with that, is kind of a cool capability," says Dr. Donald Whiting, chair of the Allegheny Health Network Neuroscience Institute.

Research & Development Innovation Surgical Procedures

Warning Letter Roundup & Recap – Nov. 20, 2018

A maker and contract sterilizer of surgical trays and kits was dinged by FDA for not having an employee responsible for overseeing day-to-day quality operations, among other quality systems violations. The warning letter to American Contract Systems was the only device-related missive released by the US agency this week.

Device Warning Letters FDA Compliance

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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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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

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

Newly Elected Dems Will Defend Preexisting Conditions, May Fight Device Tax Repeal

Experts predicted continuing fights over insurance protections for preexisting conditions, and that newly elected Democrats may oppose device tax repeal in 2019 and 2020, due to the potential loss of federal revenue to pay for expanded health care coverage.

Elections Policy

Drug/Software Combos Likely Won't Require Pre-Market Review By US FDA

The agency explains that most drug-use-related apps will be considered promotional labeling, but sponsors should sometimes seek advisory comment. US FDA is seeking feedback from a variety of stakeholders on its discussion proposal for regulating prescription-drug-focused software.

Digital Health Advertising, Marketing & Sales

Precarious Draft Brexit Agreement: How It Could Impact The Medtech Sector

The UK does not know which direction its future will take, with respect to its current leadership and its relationship with the EU, from one hour to the next. But if the EU/UK Brexit Draft Agreement is accepted, there will be some short-term relief for the medtech sector.

Brexit United Kingdom

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

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

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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BoneSupport Encouraged By Top-Line Data From CERTiFy Trial Of Cerament Bone Void Filler Injectable

Results of the CERTiFy study demonstrate Bonesupport's Cerment bone-void filler is non-inferior to autograft in treating tibia plateau fracture defects. The company says it is a major milestone for the company and will change in the standard of care for this kind of injury.

Clinical Trials Orthopedics Commercial

Medtech Money Flow: M&A And VC Deals, Nov. 12-18, 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 Nov. 12 and Nov. 18, 2018.
M & A Commercial

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

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

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

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

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 Research & Development

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

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

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

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