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An FDA Age-Based Predicate Policy Would Be Arbitrary, Reg Experts Complain

The device industry is still sorting out the implications of US FDA's recent proposals to make the agency describes as a major update to the 510(k) process. But regulatory experts say the agency's focus on finding an age-based cut-off for 510(k) predicate devices is misguided, and some argue that Congress should need to sign off on any of the floated policies.

FDA Regulation Policy

CarThera Secures First VC Investment To Run Pivotal Study Of Glioblastoma Therapy

CarThera has secured its first financial round from institutional investors to launch a pivotal trial evaluating the company's Sonocloud ultrasound therapy for patients with recurrent glioblastoma.

Financing Cancer Commercial

'Reined-In' US Diagnostics Legislation Adds Pre-Certification, Other Updates

A revised bill is circulating in both the US House and Senate to revamp FDA regulation of diagnostics. It would allow the agency to leverage a pre-certification process to validate test developers and includes other updates that are likely to appeal to the lab sector. But user fees and other elements could still be contentious.

In Vitro Diagnostics Legislation Regulation

Market Intel: Managing Diabetes With Digital Apps: Physicians' Views On Pros And Cons

With a growing number of diabetes apps on the market, patients and physicians can obtain a large amount of data to help manage the disease. In this second part of a two-part series on the blood glucose monitoring devices market, two endocrinologists express their views on the considerations and pitfalls of using apps to help manage diabetes, and they recommend specific apps.

Diabetic Care Digital Health Commercial

EU UDI Deadlines, Documents And Planning: What Does Industry Need To Know?

Requirements for Unique Device Identification (UDI) will ultimately apply to all medtech manufacturers selling products in Europe. The upcoming mandates are complex and technical both for those developing UDI standards and for industry. Medtech Insight looks at progress so far on an EU UDI system, and sheds light on developments, terminology and how the system links together.

Compliance Regulation Medical Device

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Policy & Regulation Explore this Topic

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'Lame Duck' Bill Would Halt Device Tax Until 2025

A revised tax bill introduced by the top lawmaker in the Ways and Means Committee could freeze the Obamacare medical device tax for an additional five years. It is expected a new Congress will be more politically contentious, making it harder to pass an extended moratorium or repeal the bill; this latest effort may be industry’s best chance.

Legislation Policy United States

When Medtech Companies Have Redress Against The European Commission: CJEU Ruling

The European Commission must, like everyone, ensure that it complies with its responsibilities within the context of EU rules governing medical devices. A recent European Court ruling may open the door for companies to seek compensation from the European Commission for related failures. Two attorneys explain.

Legal Issues Regulation Europe

Adverse-event Reporting Failure Leads To Guilty Plea For Olympus, Exec

Olympus Medical Systems and a former senior executive have pleaded guilty to allegations that they sold duodenoscopes even after failing to submit required adverse-event reports on them.

Legal Issues Enforcement

US FDA Report Confirms Duodenoscope Contamination Risk

An early look at the results of post-market studies that had been ordered by US FDA for duodenoscopes highlights ongoing sterilization issues.

Safety Regulation

Warning Letter Roundup & Recap – Dec. 11, 2018

No device-related warning letters were released by US FDA the week of Dec 11.
Medical Device Device Warning Letters

QUOTED. Dec. 11, 2018. Greg Crist.

US industry lobbyists are downplaying the practical impacts to the industry – at least so far – of the scathing report of medical malpractice, undue government influence, and questionable marketing practices published by the International Consortium of Investigative Journalists in recent weeks.

Quoted Policy

Opinion: The Great Implant Scandal Or 7.7 Billion Reasons To Celebrate Medical Devices?

Investigative journalists, tort lawyers, the judicial system and public opinion all provide checks and balances on medical research, industrial innovation and commercial exploitation of health-care technologies. Whether those affected like it or not, these well-intentioned elements of society demand accountability of an industry that has a profound effect on all our lives. The "Implant Files" episode is a reminder for medtech stakeholders across the world that nothing can be taken for granted, says medtech industry and regulatory consultant Trevor Lewis in this guest column for Medtech Insight.

Implant Files Regulation

UK Government Prioritizes Medical-Device Transport In No-Deal Brexit

The UK government has been working on plans to ensure medical devices, among other goods, can still "flow into the country, and won't be delayed by additional controls and checks."

Brexit Policy

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Deadline For ISO 13485 Survey Extended To Dec. 31

Stakeholders can still fill out a survey that asks for feedback on potential plans to retool international quality systems standard ISO 13485. The deadline for the survey was extended so the International Organization for Standardization (ISO) committee that oversees revisions to ISO 13485 can make a stronger case against opening it up for a rewrite.

International Standards

Compliance 360° Part 14: Leverage FDA Data To Stay In The Agency's Good Graces

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this fourteenth installment, former FDA investigations branch director Ricki Chase explains how device-makers can leverage publicly available data from the agency to determine where they might fall short when it comes to complying with FDA rules and regulations.

Compliance 360 FDA

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

Commercial Explore this Topic

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MTI 100: Major M&A Bookends Year Of Mainly Steady Growth For Leading Medtech Groups

In Medtech Insight's latest rankings of top 100 revenue-earners in the medical device and diagnostics sector, it was steady as she goes for most of the multinational medtechs, with some major exceptions. But there will be more M&A reflected in next year's ranking based on 2018 revenues. Also, medtech groups leading the global market tightened their grip further in 2017, as providers chose to partner more and more with fewer suppliers who can offer a wider provision of services.

Commercial M & A Business Strategies

Investors Pump $30M Into Israeli Heart Failure Therapy

WhiteSwell has received $30m in financing to support development of a catheter-based device for treating acute decompensated heart failure. The investment round was led by RA Capital Management and an InCube Ventures syndicate, with participation from other investors.

Cardiology Financing

Execs On The Move: Hill-Rom Appoints Former New CFO, Promotes Two VPs

Medical equipment and technology systems-maker Hill-Rom Holdings taps a former Mallinckrodt financial executive as its new chief financial officer, while promoting new VPs in Front Line Care and Strategy and Investor Relations. More personnel moves from around the medtech industry.

Appointments Commercial

Pear Picks Up Prescription Opioid App Clearance

Novartis subsidiary Sandoz will lead the US launch of Pear Therapeutics' reSET-O prescription-grade mobile app for opioid use disorder in the coming days following US FDA go-ahead.

Digital Health Approvals

Medtech Money Flow: M&A & VC Deals, Dec. 3 - 9, 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, from Dec. 3 - 9, 2018.  
M & A Financing

QUOTED. Dec. 10, 2018. David Ahn.

The global blood glucose monitoring devices market is expected to exceed $7bn by 2022, driven in large part by the fastest-growing continuous glucose monitoring segment. Sales of the much larger blood glucose meter segment, meanwhile, are expected to drop to $3.7bn in 2022 from nearly $5bn in 2017 amid rising competition from lower-cost manufacturers and tech giants entering this space. But the major blood glucose meter makers are also reinventing themselves by offering smarter technologies. See what David Ahn, an endocrinologist and program director at the Mary and Dick Allen Diabetes Center at the Hoag Hospital in Newport Beach, California said about the issue here.


Commercial Digital Health

Work With Patients To Design Trials For Anti-Hypertensive Devices, FDA Advisors Suggest

FDA is looking forward to reviewing PMAs from several anti-hypertension devices in the coming years – including technologies from Medtronic, ReCor Medical, ROX Medical, and Vascular Dynamics – so the agency convened its Circulatory System Devices Panel on Dec. 5 to get recommendation on pre-market clinical trial design, post-approval study design, indications and labeling for such devices.

Advisory Committees Cardiology

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Starts & Stops: Edwards Updates Mitral And Tricuspid Trials

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from Dec. 3 through Dec. 9, including trial announcements from Edwards Lifesciences, Nemura Medical, Hancock Jaffe, Johnson & Johnson, and more.

Starts & Stops Tracking Trials Clinical Trials

Global Device Approvals, Weekly Snapshot: New Endobronchial Valve, Cell Therapy

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Newly added devices include an endobronchial valve for emphysema approved in the US and an autologous cell therapy for urinary incontinence approved in Japan.

Approvals Innovation

Results Recap: Long-Term Results Support NovoCure's Optune Brain-Cancer Technology

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. 30 – Dec. 6, includes results of a retrospective post-hoc sub-group analysis of the EF-14 phase III pivotal trial of Novocare's Optune system in newly diagnosed glioblastoma, one-year data from a study of Vieve Medical's Geneveve treatment of mild-to-moderate stress urinary incontinence, and complete results from the Long-Term Treatment Study of NeuroPace's RNS system to treat epileptic seizures.

Tracking Trials Clinical Trials

Work With Patients To Design Trials For Anti-Hypertensive Devices, FDA Advisors Suggest

FDA is looking forward to reviewing PMAs from several anti-hypertension devices in the coming years – including technologies from Medtronic, ReCor Medical, ROX Medical, and Vascular Dynamics – so the agency convened its Circulatory System Devices Panel on Dec. 5 to get recommendation on pre-market clinical trial design, post-approval study design, indications and labeling for such devices.

Advisory Committees Cardiology

Global Device Approvals, Weekly Snapshot: New Shoulder Component, AAA Graft

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Newly added devices include a new LimaCorporate should component, US approval of the Incraft aneurysm stent graft and a first-in-class newborn-screening diagnostic.

Approvals Research & Development

Device Week, Nov. 30, 2018 – Bioprinting Is Moving From Far-Fetched To Reality; ‘Femtech’ Investment Heats Up

In this edition of Device Week, Medtech Insight managing editor Marion Webb discusses the ongoing research that could lead to 3D-printing of human replacement organs and reporter Catherine Longworth highlights the developments in “femtech,” medical technology primarily or exclusively for female patients.

Device Week Innovation

Global Device Approvals, Weekly Snapshot: PMA Drought Continues

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. A electrical stimulator for GI disease is among devices that made the list this week. Also, a drought in original PMAs and panel-track supplements in the US.

Approvals Research & Development
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