From Accuray’s India approval to Masimo and PositiveID launching a Bluetooth-enabled thermometer, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. India approves Accuray’s Radixact X9 radiation therapy device Accuray announced in a June 21 press release that it has received an Atomic Energy Regulatory Board Type Approval in […]
A guide to source data extraction and verification
Reviewing a medical chart can be a daunting task for anyone on the research team. However, ensuring proper data extraction and source data verification is paramount to ensuring data integrity and subject safety in your clinical trial. Understanding that source data may be located in a multitude of areas within a medical chart is one of […]
Singapore HSA implements major medical device regulatory changes
By Stewart Eisenhart, Emergo Group Medical device market regulators in Singapore have begun enforcement of key regulatory changes affecting areas such as low-risk devices, telehealth products and quality system requirements starting June 1, 2018. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only […]
7 medtech stories we missed this week: June 15, 2018
From Cytosorbents opening a new U.S. manufacturing facility to DyAnsys received FDA clearance for a wearable to treat opioid withdrawals, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Cytosorbents opens new U.S. manufacturing facility CytoSorbents announced in a June 12 press release that it has opened a new […]
5 things medtech manufacturing executives learned from their dads
Sometimes working for your dad seems like destiny, but taking over the family business wasn’t always the plan. There are many second- and third-generation medtech manufacturers run by executives following in their dads’ footsteps. Here’s what they learned. Eric Crainich, president and owner of Design Standards (Charlestown, N.H.), was told from a young age that […]
Effective monitoring for a medical device trial
While procedures, checklists, guidance documents, report templates and all sorts of other things combine to form the infrastructure for monitoring, what is possibly even more important is the shared mindset. The acceptance by all that regardless of the title, there is a shared responsibility in calling out issues, in looking purposefully at this document, in […]
How you can control lab-grown heart cells with a remote control light
University of California San Diego researchers have created a technique that speeds up and slows down human heart cells that are being grown in a dish on command by shining light on them and varying the intensity. The heart cells are being grown in graphene which turns light into electricity, a more realistic environment that […]
7 medtech stories we missed this week: June 8, 2018
From Royal Philips receiving FDA clearance to NeuroPace launching its epilepsy treatment device, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Philips’s Ingenia Elition 3.0T MR scanner Royal Philips announced in a June 5 press release that it has received FDA 510(k) clearance for its Ingenia […]
7 MD&M East exhibitors you need to know
MD&M East is a major medtech tradeshow on the East Coast of the U.S., showcasing some of the industry’s latest developments in packaging, automation, plastics, design engineering and quality. The event houses over 750 suppliers with more than 8,000 attendees who are able to network, explore new career opportunities and find partners for projects. The […]
Comparing drug and medical device clinical trials
Understanding the similarities and appreciating the differences between drug and medical device clinical trials is important for every trial participant—from the patients to the researchers. Whether the product being investigated is a drug or device, a well-organized, efficient clinical trial can save time and money for each individual and organization involved. Additionally, the faster and […]
FDA plans fast-track development and marketing program for medical devices that treat opioid addiction
By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have initiated a new campaign to support development and commercialization of novel devices aimed at pain treatment and opioid addiction. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
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