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Breakthrough Pathway Final Guidance Eases Sponsor-Regulator Interaction Requirements

US FDA issued a final guidance that sets out requirements for its new Breakthrough Devices Program mandated by Congress. Under the new program, which replaces the Expedited Access Pathway, sponsors have more certainty about how quickly they will get responses from the agency and fewer requirements when setting up early interactions.

FDA Innovation Policy

Brexit And The EU's REACH Chemicals Regulation: What Happens When The UK Goes It Alone?

The UK's departure from the EU will have a critical impact on chemicals rules, and it's critical for medtech companies to understand what will happen in terms of future trading and why compliance costs will rise.

Brexit United Kingdom Europe

FDA Marches Forward With 'STeP' Program To Aid Development Of Significantly Safer Medtech Products

The US agency is planning to launch another accelerated device approval program along the lines of its successful Breakthrough Devices Program. But this one, the Safer Technology Program (STeP), would focus on devices with enhanced safety features.

FDA Innovation Policy

US FDA Medical Software Report Rests Concerns Of Increased Regulation

Based on a provision in the 21st Century Cures Act, US FDA has released a report that shows that certain types of medical software not regulated by the agency is overwhelmingly beneficial to the public with few risks. The report seems to allay industry fears that FDA may use it to ask for more oversight authority of such products.

Digital Health FDA Policy

QUOTED. Dec. 18, 2018. Scott Gottlieb.

A new report from US FDA concludes, for the most part, that the benefits of a slew of non-device software functions not regulated by the agency outweigh their risks. The report sends a signal to industry that regulators are happy with the current situation and have no incentive to expand their oversight of such products. See what FDA Commissioner Scott Gottlieb said about it here.

Quoted Digital Health FDA

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Policy & Regulation Explore this Topic

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FDA's Maisel Updates Industry On Maturity Model Pilot, Facility Inspections, MDSAP

US FDA device center official William Maisel offered an update on the agency’s ongoing efforts at an industry conference last week, touting recent successes in Medical Device Single Audit Program (MDSAP) expansion and its Voluntary Medical Device Manufacturing and Product Quality Pilot Program.

FDA Quality Enforcement

Texas Court Ruling Invalidating ACA Threatens Preexisting Illness Coverage, But It's Not The Final Word, Congress Says

A Texas federal district court judge ruled late on Dec. 14 that all of the Affordable Care Act – including parts mandating coverage of preexisting conditions, the medical device excise tax and reporting by medtech firms of payments made to health-care providers under sunshine provisions – are invalid because the health-care law's individual mandate was struck down by a 2017 tax law. But Congress and legal experts say the ruling will be challenged.

Legal Issues Legislation Regulation

Warning Letter Roundup & Recap – Dec. 18, 2018

No device-related warning letters were released by US FDA the week of Dec. 18.

Device Warning Letters FDA

Americans Pay 4 To 6 Times More For Cardiac Devices Than Europeans

A variety of factors is causing US citizens to pay anywhere from four to six times more for their cardiac implant devices than patients in Germany, Italy and the UK, says a recent blog piece by Cornelia Henschke and Rita Redberg in Health Affairs.

Policy Market Access

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

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

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

'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

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

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

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

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.

Quality Control Safety

Commercial Explore this Topic

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Start-Up Spotlight: 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

Medtech Money Flow: M&A And VC Deals, Dec. 10-16, 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. 10-16, 2018.

M & A Deals

Mobidiag Forms Joint Venture With Autobio

Finnish molecular diagnostics company Mobidiag is partnering with Chinese company Autobio Diagnostics in a new joint venture to commercialize its Novodiag platform for infectious disease diagnostics.

Deals Diagnostics

Germany Puts Implant Files In Perspective, As Industry Looks Toward 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

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Starts & Stops: Agile Therapeutics Updates Twirla Patch Progress; J&J Launches Embotrap II Registry

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from Dec. 10-16, including trial announcements from Johnson & Johnson/Cerenovus, Agile Therapeutics and DexCom.

Starts & Stops Tracking Trials Research & Development

Global Device Approvals, Weekly Snapshot: FDA Approves Medtronic's Resolute Onyx, Resolute Integrity DES

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Newly added devices include US FDA approval of Medtronic's Resolute Integrity and Resolute Onyx zotarolimus-eluting coronary stents, and agency approval and a CE mark for InSightec's ExAblate ultrasound device for treating tremor-dominant Parkinson's disease.

Approvals Innovation

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

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

Device Week, Dec. 13, 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

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
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