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Clinical Trials

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Starts & Stops: Vectorious Launches First-In-Human Trial Of V-LAP Left-Atrial Monitor

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from Dec. 24-30, so there is just one entry this week - Vectorious' announcement of the first-in-human trial of the V-LAP left-atrial monitor.

Starts & Stops Tracking Trials Research & Development
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NZ To Replace 'Outdated And Piecemeal' Device Rules

There are significant changes in store for New Zealand’s medical device sector, including a new regulator and a set of pre- and post-market regulatory controls.

New Zealand Policy & Regulation

Results Recap: Pulse Biosciences Announces Results Of Sebaceous Hyperplasia Study

This week's edition of Medtech Insight's Results Recap, the weekly roundup of major device trial-results from Meddevicetracker.com, includes just one entry as the 2019 is off to a slow start for trial results announcements. Pulse Biosciences announced encouraging results from the clinical efficacy study of its Nano-Pulse Stimulation technology to treat patients with sebaceous hyperplasia.

Tracking Trials Research & Development

Starts & Stops: Abbott Stops Two-Clip Trial Of MitraClip; PROMISE Trial of Eversense XL CGM Begins

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from Dec. 30 to Jan. 7, including announcements from Abbott, Roche, Insightec, and Terumo.

Starts & Stops Tracking Trials

Myriad Finishes Big Year With NICE Endorsement Of EndoPredict Breast Cancer Diagnostic

The UK's National Institute for Health and Care Excellence (NICE) has included Myriad Genetics' EndoPredict in its recommendations for guiding adjuvant chemotherapy decisions for certain early breast cancer patients. The recommendation comes just a few weeks after new data showing the long-term prognostic value of the EndoPredict test was presented at the San Antonio Breast Cancer Symposium. The company is also making progress on its Vectra rheumatoid arthritis prognostic system with the publication of a large commercial cohort and several clinical studies on development of the adjusted Vectra score.

Clinical Trials In Vitro Diagnostics

FDA Lowers Age For Electroshock Devices From 18 To 13 In Final Order; Gives Makers Of Down-Classified ECTs 6 Months To Submit 510(k) Amendments

A Dec. 26 final administrative order from FDA says people as young as 13 who suffer from major depressive disorders can now be treated with electroconvulsive therapy (ECT) devices that have been newly down-classified by the US agency, from high-risk class III to moderate-risk class II with special controls. Manufacturers of ECT devices covered by the final order have 180 days to submit an amendment to their product's 510(k) that shows how their device meets the special controls. Meanwhile, makers of class III ECT devices that were not redesignated as class II must file a pre-market approval application with FDA within 90 days.

Neurology FDA

Starts & Stops: Aortica Studies AortaFit Case Planning Software With Medtronic's Navion AAA

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from Dec. 17-23, including trial announcements from Smith & Nephew, MedShape, Pear Therapeutics, Bayer, Cerus, and  more.

Starts & Stops Tracking Trials

QUOTED. Dec. 21, 2018. Todd Newton.

ReShape Lifesciences has acquired the Lap-Band adjustable gastric band surgery system from Apollo Endosurgery in exchange for $17m and the ReShape Balloon intra-gastric bariatric product line. See what Apollo CEO Todd Newton said about the deal here.

Quoted Companies

Results Recap: Post-Market Results From Avinger's Pantheris Peripheral OCT System; Nemaura Announces sugarBEAT CGM Results

This week's edition of Medtech Insight's Results Recap, the weekly roundup of major device trial-results from Meddevicetracker.com, includes preliminary analysis of results from Avinger's SCAN clinical study, a 12-patient, 240-image post-market study of Avinger's Pantheris optical coherence tomography in the peripheral arteries and results of an 18-patient early-feasibility study showing Nativis' Voyager device is safe for treatment of recurrent glioblastoma.

Tracking Trials Research & Development

Meeting Planned To Discuss Drug-Eluting Device Death Risk

Two trials of paclitaxel-coated devices to treat peripheral arterial disease have been halted in recent weeks due to reports the devices were tied to a higher mortality risk. Endovascular physician group VIVA is organizing a February meeting to discuss the issue. Two trials of paclitaxel-coated devices to treat peripheral arterial disease have been halted in recent weeks due to reports the devices were tied to a higher mortality risk. Endovascular physician group VIVA is organizing a February meeting to discuss the issue.

Cardiovascular Clinical Trials
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