Webinar: How to make sense of safety oversight in clinical research — DSMBs, CECs and Medical Monitors

Thursday, March 22, 2018 2 p.m. Eastern time / 11 a.m. Pacific time     This webinar will provide clinical research professionals with an understanding of safety oversight for clinical studies, including regulatory requirements and best practices. The presentation will include a discussion of the FDA’s Guidance on the Establishment and Operation of Clinical Trial

Antidote looks to leverage AI, travel e-commerce tech to improve clinical trial enrollment

Clinical trial artificial intelligence company Antidote is looking to improve access to and enrollment in clinical trials using technology from the e-commerce world, according to a Wired report. Former travel and airline fare aggregator Kayak VP Pablo Graiver is heading the operation, which streamlines access to clinical trials for patients seeking them out.   Read

Report slams European Union’s high-risk medical device approvals rate

A health economics and outcomes research group has concluded that the assessment for high-risk medical devices in the European Union is of low quality and needs improvement. The report appears in the December 2017 issue of Value in Health by ISPOR. The authors looked at 1,376 health technology assessment (HTA) reports filed between 2010 and 2015.

How to work with a preclinical contract research organization

When outsourcing medical device laboratory testing, knowing what the regulatory and business requirements are up front is critical to the success of your testing program. Amy A. Schade, Felice Randi LaMadeleine and J. Heléne Andersson, Toxikon Requests such as unusual application of technical or regulatory guidelines, shortened timelines, nonstandard study designs and custom reports are

Webinar: Could this new software help you with clinical trials?

This webinar was presented live on Tuesday, Nov. 28, 2017. Click below to watch on demand.     Staicy is a next-generation health and research management platform which provides full transparency of your clinical data. Learn about integrating seamlessly your internal and external clinical applications and utilizing staicy’s proprietary functionality to uniquely select a geographical

The top 10 medical disruptors of 2018

Each year the Cleveland Clinic determines what the top 10 disruptors in healthcare will be for the following year. The criteria to be considered a disruptor is that it has to be so innovative that it could change healthcare in a significant way in the next year. Approximately 150 to 200 Cleveland Clinic physicians from

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Medtech stories we missed this week: Oct. 20, 2017

From InspireMD’s distribution deal to RenalGuard touting a new study, here are seven medtech stories we missed this week but thought were still worth a mention. 1. InspireMD inks Chile distribution deal InspireMD announced in an Oct. 12 press release that it has signed a distribution deal with CorpMedical Chile to distribute the MGuard Prime

Medtech stories we missed this week: Oct. 6, 2017

From Intellijoint’s CE Mark to Patrona Medical and Kopis’ new partnership, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Intellijoint CE Mark for flagship hip navigation Intellijoint surgical announced in an Oct. 4 press release that it has received CE Mark for its Intellijoint HIP System in

How to design a successful embolic protection devices clinical trial

Embolic protection devices could reduce risks of interventional cardiac procedures such as TAVR, but their efficacy is hard to prove. David Novotny, Novella Clinical The embolic protection device (EPD) market is expected to grow into a billion-dollar industry if the device becomes the standard safety protocol for transcatheter aortic valve replacement (TAVR) and other interventional

Medtech stories we missed this week: Sept. 15, 2017

From Acera Surgical and Telos Medical’s partnership to Xtant Medical’s 510(k) clearance, here are seven medtech stories we missed this week but thought were still worth a mention. 1. Acera Surgical partners with Telos Medical for Restrata wound matrix trial Telos Partners announced in a Sept. 14 press release that Acera Surgical has chosen Telos to

Medtech stories we missed this week: September 8, 2017

From BrainScope’s pediatric traumatic brain injury assessment device to EOS Imaging releasing new surgery planning software, here are seven medtech stories we missed this week but thought were still worth a mention. 1. BrainScope to develop pediatric traumatic brain injury assessment device BrainScope announced in a Sept. 7 press release that it will immediately start creating

Sirtex swings to a loss after ‘challenging’ year

Shares in Australian cancer treatment developer Sirtex Medical (ASX:SRX) plunged more than 15% yesterday after the company posted a net loss of -A$26.9 million in 2016, compared to a profit of A$54 million the year before. Sirtex has faced a barrage of obstacles this year, including a number of clinical trials that failed to meet primary endpoints.

Medtech stories we missed this week: August 11, 2017

From Xtant Medical’s 510(k) extension to Varian Medical’s distribution deal, here are seven medtech stories we missed this week but thought were still worth a mention. 1. FDA extends Xtant Medical’s 510(k) for Calix C spinal implant Xtant Medical announced in an Aug. 9 press release that the FDA has cleared its product line extensions

Medtech stories we missed this week: July 21, 2017

From Second Sight’s South Korean market entry to Sanuwave’s Indonesian distribution deal, here are medtech stories we missed this week but thought were still worth mentioning. 1. Second Sight enters South Korea market Second Sight announced in a July 5 press release that it has entered the market in South Korea with the implantation of two

Clinical evaluation reports and China: What you need to know

Grace Fu Palma, China Med Device China introduced new requirements for clinical evaluation reports in 2015. Understanding the China Food and Drug Administration’s new CER requirements can help companies to be better prepared in their CFDA submissions. 1. Summarizing data The CER must summarize the data from clinical literature, clinical experience, and clinical trials, etc.