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Good Progress Toward Notified Body Designations: But Is There A Threat?

The European Commission looks to be on track, and in some cases ahead of schedule, in steps toward the designation of notified bodies under the new EU device and diagnostic regulations. But could recent bad press create delays?

Europe Medical Device Regulation

Smart Glove Makes Stroke Rehabilitation A Gaming Adventure

After making its Korean IPO debut, Korean-American medtech startup Neofect Inc. hopes to bring its gamified rehabilitation solutions to more stroke and spinal injury patients in the US. The company developed the Rapael Smart Glove, an AI-driven device that combines video gaming and hand-motion exercises to help stroke patients use their hands again. Neofect's new NeoMano glove for stroke and spinal injury patients will makes its market debut in 2019.

StartUps and SMEs Start-up Spotlight 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

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

Device Week, Dec. 14, 2018 – Physicians Offer Perspective On Diabetes Apps; Researchers Apply Cancer Radiation To Cardiac Arrhythmia

In this edition of Device Week, Medtech Insight’s weekly podcast, Marion Webb gives an overview of physicians’ perspective of digital apps for diabetes patients and Reed Miller discusses the early research into a potentially promising non-invasive radiation technique for treating ventricular tachycardia.

Device Week Market Intelligence Digital Health

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Policy & Regulation Explore this Topic

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'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

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 Compliance

Device Servicing And Remanufacturing: US FDA, Stakeholders Try To Draw Distinction

US FDA’s device center in concert with third-party servicers and original equipment manufacturers are working toward consensus on how to differentiate medtech "servicing" from "remanufacturing" activities. Progress was made at a recent workshop in laying out ways that better training and more data sharing will help.

Regulation Legislation

QUOTED. Dec. 13, 2018. Quynh Hoang And Elaine Tseng.

FDA is considering publishing a list of devices 510(k)-cleared based on predicates over ten-years-old to encourage companies to adopt new predicates. In a joint written response to Medtech Insight's questions, medical device regulatory experts with law firm King & Spalding said an age-based cut-off will not necessarily address the problem FDA is trying to address.

Quoted Regulation

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

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

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

Germany Puts Implant Files In Perspective, As Industry Looks Towards 2019

Europe's biggest medtech industry and market, Germany, was in the crosshairs of the Implant Files and its ICIJ reporters, and predictably it caused a major stir. The episode has been a wake-up call for medtech, but industry hasn't let it develop into the crisis it briefly threatened to become, and is now looking beyond it and to the commercial challenges of 2019.

Germany Commercial

FDA Give Green Light For Pilot Study Into Colorectal Cancer Detection Pill

FDA has given Israeli company Check-Cap the green light to initiate a pilot study of its C-scan system for colorectal cancer screening.

Clinical Trials Cancer

WashU Researchers Plan Major Trial Of Non-Invasive Radiation Ablation For Ventricular Tachycardia

Physicians developing a promising technique for noninvasive cardiac radioablation for ventricular tachycardia are working with US FDA to develop a large multicenter trial of their technique following the success of a five-patient case-series and an 18-patient prospective study. 
Clinical Trials Research & Development

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

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

Clinical R&D Explore this Topic

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Into 2019: Intelligent Innovation's Role In The Shape Of Medtech Things To Come

Brexit, the "Implant Files" and the new EU regulations – however large they loom at present, they will in time be seen as mere tactical challenges for a global medtech industry working hard to ensure that it is ready for the massive health-care delivery and service-oriented changes to come. Preparing for the future and maximizing current market penetration – in the UK, the EU and beyond – were key themes at UK HealthTech 2018, held in Cardiff, Wales.

Digital Health Market Access Medical Device

Results Recap: 12-year Data Supports Neovasc's Reducer To Treat Angina

This week's edition of Medtech Insight's Results Recap, the weekly round-up of major device trial-results, features just one entry - long-term data from a prospective, non-randomized, single-arm anatomic and clinical evaluation of chronic refractory angina patients implanted with Neovasc's Reducer at a single medical center as part of the first-in-human clinical study in 2005. The patients treated in the trial showed sustained improvement in angina class out to 12 years and all seven Reducers implanted in the study were still patent, with no signs of strut fractures, dislocation, thrombosis, or migration.

Tracking Trials Clinical Trials

WashU Researchers Plan Major Trial Of Non-Invasive Radiation Ablation For Ventricular Tachycardia

Physicians developing a promising technique for noninvasive cardiac radioablation for ventricular tachycardia are working with US FDA to develop a large multicenter trial of their technique following the success of a five-patient case-series and an 18-patient prospective study. 
Clinical Trials Research & Development

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

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

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
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