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Clinical / R & D

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Starts & Stops: Corlife's Decellularized Human Pulmonary Valve Shows Early Promise

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions each month. News about trials of cardiovascular devices, especially novel heart valve replacement technologies, lead this month's edition, covering mid-May through mid-June.

Starts & Stops Clinical Trials Research & Development
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Clinical Trials

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Latest From Clinical Trials

US FDA Updates Clinical Trial e-Reporting, e-Signature Guidance To Keep Up With Tech

In a draft guidance on electronic signature and record requirements for clinical trials used to submit applications across FDA product centers, the agency responds to technological advances since it last issued guidelines almost 15 years ago, while keeping its narrow enforcement of the "Part 11" rules in place.

Regulation Clinical Trials

Positive Data Give DePuy Synthes' Attune Further Knee-Up

Results of a study by the Canadian Radiostereometric Analysis Network show that the tibial base of DePuy Synthes' Attune knee replacement achieves stable fixation out to two years and recently announced results from the UK's National Joint Registry show a 98.1% four-year implant survivorship rate with Attune in a "real-world" setting.

Orthopedics Clinical Trials

ASCO 2017: Myriad's MyRisk; Nanobiotix' NBTXR3; Chronix' CNI Test; Sirtex SIR-Spheres; ANGLE’s Parsortix CTC Harvester

Over 30,000 oncologists and other health professionals attended the 2017 American Society of Clinical Oncology annual meeting in Chicago, June 2-6. This year's meeting included several presentations on emerging cancer diagnostic and device treatment strategies, including genetic tests, liquid biopsy systems, radioenhancers, and microspheres intended to improve chemotherapy outcomes.

Cancer In Vitro Diagnostics
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New Technology

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Latest From Innovation

Virtual Reality: The New Game In Mental Health Care To Improve Outcomes

Virtual reality is seeing an upsurge in use by mental health practitioners for treating conditions such as post-traumatic stress disorder, panic disorders and anxiety in a safe and controlled manner. With the advent of affordable VR headsets and technological advances, companies and researchers worldwide are seizing on the opportunity to bring such techniques as VR exposure therapy and cognitive behavioral therapy to telemedicine, specialty clinics and directly to consumers to improve outcomes and better lives.

Neurology Innovation

How Israel's Digital Innovators Are Capturing The Minds Of Medtronic And Others

The positive growth trend seen in Israel's digital health industry is galvanizing big players like Medtronic into action to start developing and recognizing synergistic technologies for future business. Medtech Insight met with members of MindUP, Israel's first digital health incubator and the result of a cross-industry partnership, at the MiXiii Biomed conference in Tel Aviv, to discover how the joint venture is driving the next generation of digital innovations.

Digital Health Innovation

London Tech Week: Asthma Sensors, Smartphone Health Monitoring & Eczema Management Garments

Early-stage UK businesses took center stage at a medtech-focused investor event held as part of London's Tech Week. The weeklong festival of events, June 12-16, are intended to strengthen London's status as a global tech hub and celebrate cutting-edge innovation.

StartUps and SMEs Innovation
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Approvals

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Latest From Approvals

OUS Approvals Analysis: IVDs Lead A Slow Month

Only 10 approvals from outside the US were recorded in May in Medtech Insight's approvals tracker. Half of those were for in vitro diagnostics, including three for companion diagnostic for cancer drugs.

Approvals Innovation

US Approvals Analysis: 510(k) Clearances Spiked In May

In May, US FDA achieved its highest monthly total of 510(k)s clearances in more than two years. Here's a snapshot of the agency's approval and clearance activity last month from Medtech Insight's Approvals Tracker.

Approvals Medical Device

FDA Go-Ahead For Sentinel TAVR Filter Could Drive Procedure Volumes, Firm Says

Claret Medical plans to start rolling out the TAVR accessory immediately at clinical trial centers, with full market release expected in 2018. The company is also trying to get a Medicare add-on payment.

Approvals Medical Device
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