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Medtech Insight

Companion Diagnostics Webinar Recording

By Derrick Gingery 24 May 2018

Companion diagnostics are poised to be a huge growth area worldwide, with a CAGR of 20.1% over the next 5 years, making it a $6B industry by 2022. These often in-vitro medical devices provide essential information for the efficacy of a corresponding drug or biological product, and are also used for pre-determining the efficacy of treatment. Their growth is being propelled in most countries by a number of favorable factors.

Medtech Insight

Despite Only Two Parallel Review Success Stories, CMS Touts Better Coordination

22 May 2018

While only two devices have received approval and a national coverage determination through US FDA/CMS' parallel review program, a top CMS official says industry needs to look beyond just the numbers. Instead, she says the parallel review program is part of a sea-change that has allowed for better communication between CMS, FDA and sponsors.

Medtech Insight

HRS 2018 Wrap-Up: Tendril Lead Failures; Metaanalysis of Contact-Force Catheter; LuxCath's OmniView; More Micra Results

By Reed Miller 22 May 2018

The 2018 Heart Rhythm Society scientific sessions in Boston covered a variety of presentations of new electrophysiology clinical data, including a report on the failure of St. Jude's Tendril leads, a meta-analysis of contact-force catheters for atrial-fibrillation ablation, and new data on Medtronic's Micra leadless pacemaker.

Medtech Insight

Market Intel: Liquid Biopsies For Cancer Screening - Far From Reach Or Close At Hand?

15 May 2018

While liquid biopsy is becoming routine for cancer treatment stratification and monitoring, using blood tests to screen for early cancer in asymptomatic people remains a tantalizing target. Some question how practical such a test could be but several companies are already en route - some further down the road than others - to achieve this goal. Illumina spin-out Grail is one of these companies and while it is not alone, in a field where size matters, it may have an advantage. This article delves deeper into how these different technologies work and when they could reach the market

Medtech Insight

Belgium Ushers In Complex New Country-Specific Registration Requirements Pending Eudamed

By Amanda Maxwell 15 May 2018

Belgium is introducing new registration requirements for medical device and IVD operators June 17, ahead of the full application of the EU's medtech regulations and new Eudamed medical device database.

Medtech Insight

Start-Up Spotlight: Saluda Hopes To 'Evoke' From Down Under With First Closed-Loop Spine-Stim System

By Bob Kronemyer 15 May 2018

Aiming to improve the lives of patients living with chronic, intractable pain, Australian startup Saluda Medical Pty Limited is the first and only neuromodulation company in the world to develop a closed-loop spinal cord stimulation system (SCS). Unlike other SCS systems marketed today, Saluda’s device, currently in clinical trials, is designed to measure the spinal cord’s response to electrical stimulation, and then respond to patient's preferred stimulation.

Medtech Insight

What We Know About Notified Body Appointments Useful Insights Into Timings And Capacity

By Amanda Maxwell 15 May 2018

When will notified bodies be appointed? How many will there be? Where are the problem areas? And what are the resource issues? MedTech Europe's Oliver Bisazza answers these and many more critical questions.

Medtech Insight

US FDA Commissioner Agency Will Propose New Rule That Blends Quality System Regulation

By Shawn M. Schmitt 11 May 2018

Scott Gottlieb wrote in a May 9 blog post that the agency will propose a new rule that will blend its Quality System Regulation with international quality systems standard ISO 13485. Gottlieb claims the new rule would "harmonize domestic and international requirements, and modernize the regulation," while making sure that device-makers "adhere to high, internationally accepted quality systems."

Medtech Insight

PureTechs Akili Scores $55M Investment For Video Game Therapies

11 May 2018

PureTech Health's subsidiary, Akili Interactive, has scored a $55m investment to bring its video game therapies for treating cognitive dysfunction closer to commercialization.

Medtech Insight

Medtech Insights Device Week Podcast - Approvals And M&A

By David Filmore 12 Mar 2018

In this edition of Device Week, Medtech Insight’s Reed Miller, David Filmore and Catherine Longworth look back at the past year and the key trends in US and international product approvals, as well as in M&A activity. They also give their perspectives on what to look forward to in 2018.