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Clinical / R & D

Set Alert for Clinical R&D

Canada Prepares To Publish Draft Rules On Release Of Clinical Data

Following a public consultation earlier this year, Health Canada has asked for expert advice on its plans to allow the release of clinical data that is currently considered confidential. It expects to publish draft regulations this autumn.

Clinical Trials Canada Legislation
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Clinical Trials

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Latest From Clinical Trials

Device Week, October 19, 2017 – IVD Updates, And Watchman Scrutiny

On this week's podcast, we highlighted progress by several startups in the molecular diagnostics space, and discussed growing scrutiny in the cardiology community of Boston Scientific's Watchman stroke device.

Clinical Trials Innovation

NIH/Industry Oncology Partnership Aims For Immunotherapy Biomarkers

The US National Institutes of Health will team up with 11 different drug-makers to explore new biomarkers with a vision of precision oncology medicine.

Research & Development Personalized Medicine

Patients Want Industry To Minimize Burdens, Augment Comforts Of Device Trial Participation

Patients and patient advocacy groups at the US FDA's inaugural Patient Engagement Advisory Committee meeting said they need sponsors to minimize the burdens and augment the comforts of trial participation, and get reports on outcomes along the way. Meanwhile, industry groups worried about revealing too much confidential business information, and biasing trial outcomes.

Advisory Committees Clinical Trials
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New Technology

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Latest From Innovation

Device Week, October 19, 2017 – IVD Updates, And Watchman Scrutiny

On this week's podcast, we highlighted progress by several startups in the molecular diagnostics space, and discussed growing scrutiny in the cardiology community of Boston Scientific's Watchman stroke device.

Clinical Trials Innovation

Medovex Plans US IDE Trial For Its DenerveX Spine Surgery Device

DenerveX is a unique surgical tool used to ablate the nerve and capsular tissue on the posterior surface of the facet joint. preventing the nerve from reattaching with the goal of creating lasting relief from back pain that otherwise might require spinal fusion and/or treatment with opiate drugs.

Companies Innovation

Start-Up Spotlight: Lumicell, Shining The Light On Real-Time, Intraoperative Tumor Detection

With its coffers topped up and a new CEO in place, Lumicell is forging ahead with clinical trials of its LUM real-time, cancer imaging system, designed to improve the outcomes of surgical resection of tumors. The company's first target indication is for breast cancer and it is aiming for a US premarket approval in late Q1 of 2019.

Cancer Diagnostic Imaging
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Approvals

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Latest From Approvals

Big Promise For TransEnterix Robotic-Surgery Device, But Probably Won't Undermine Intuitive's Market

FDA's recent clearance of TransEnterix's Senhance System signals broad potential for robotically-assisted surgeries but the device is more likely to grow its own space than compete directly with Intuitive Surgical's daVinci products in many cases, analysts suggest.

Approvals Gynecology & Urology

Device Designed To Improve Spine-Surgery Outcomes Gets FDA Panel Date

US FDA says its Orthopaedic and Rehabilitation Devices Panel will convene Dec. 12 to weigh issues surrounding ongoing review of Intrinsic Therapeutics' PMA for its Barricaid anular closure device, intended to close a hole created by a spine discectomy procedure to prevent negative outcomes.

Advisory Committees Approvals

Medtech Fees To Soar In Canada Under Government Proposals

The licence evaluation fee Health Canada charges for Class IV medical devices could jump from CAN$12,347-$22,560 to $30,063 under proposals by the government agency, which says the current fees it charges for medtech and pharma are outdated.

Approvals Canada
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