All Articles in: Regulatory

Randomized Scalp Cooling Trial Shows Alopecia Reduction in Early Stage Breast Cancer Chemo PatientsFebruary 15, 2017

Results published in leading peer-reviewed US oncology journal

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First Patient for C-Scan® Colorectal Cancer Screening System TrialJanuary 20, 2017

Preparation-free, capsule-based technology has potential to improve colorectal cancer screening rates

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New Registry Data Revives EndoBarrier HopesNovember 10, 2016

Over a year since the discontinuation of its US study, GI Dynamics, Inc., says it has demonstrated clinical benefit in a German registry.

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Brexit Could Mean Higher Regulatory Hurdles for UK Medical Device IndustryJune 28, 2016

So the deed has been done, UK powers need to get on with the job of leaving the EU, while not actually leaving the EU

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New EU Device Regs: No Further SurprisesJune 20, 2016

Changes don’t alter the fact that it’s all about beefing up Notified Bodies and adding stringent Post-Marketing Surveillance… which is good.

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Powdered Medical Glove Ban on the CardsMarch 22, 2016

The days of powdered gloves may well be over, at least in the U.S., as FDA puts out a ban proposal for comment

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Consulting Firm Shines Spotlight on Post Market SurveillanceMarch 15, 2016

Maetrics reveals how to navigate post market surveillance requirements in free whitepaper

Posted in: , , Pitches New Medical Device Risk Management SoftwareSeptember 25, 2015 announces the release of its new cloud-based Risk Management Software exclusively for medical device companies to help reduce risk and ensure compliance

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Direct Flow Medical® Adds Experience to Regulatory and Clinical AffairsAugust 26, 2015

As it strives to gain U.S. approval, this most innovative of transcatheter heart valve developers has enlisted the services of an industry regulatory veteran

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Enrollment Complete in HeartWare’s Endurance2 HVAD TrialAugust 11, 2015

Device aims to be indicated as a destination therapy rather than as a bridge to transplantation

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Size Matters as Smith & Nephew Pulls Smaller Hip Resurfacing ComponentsJune 9, 2015

Smaller sized Birmingham Hip Resurfacing components are being withdrawn due to heightened risk of revision surgery

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Direct Flow Medical® Names Co-principal Investigator for U.S. Pivotal StudyJune 4, 2015

Transcatheter valve implantation using the novel Direct Flow “inflatable” valve has moved a step closer as the company appoints study leader

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Coming Soon to an Abdomen Near You? TransEnterix Submits 510(k) Application for Surgical RobotJune 1, 2015

First patient-side robotically enhanced laparoscopic surgery platform aims for U.S. market clearance

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FDA Green Light for StimGuard’s IDE Study into Implantable Overactive Bladder DeviceMay 12, 2015

Could StimGuard’s tiny implant ultimately eliminate expensive pulse generators?

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Paradise Returns as ReCor Brings in Funding for New RDN StudyApril 14, 2015

ReCor Medical has announced Series D investment of approximately $15M, which will position it to start a clinical study into its ultrasound-based renal denervation system

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Direct Flow Trial Broadened to Include High Risk Patients and CoreValve® ComparisonApril 10, 2015

FDA’s agreement to trial expansion should tell us whether novel valve design proves itself in competitive setting

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