This week we saw a few FDA 510(k) clearances and one of the 1st uses of a next-generation surgical robot in Asia. Here are medtech stories we missed this week but thought were still worth mentioning: 1. Corindus touts first Asian use of next-generation robot Corindus Vascular Robotics announced in a March 31 press release that robot-assisted […]
FDA in India – championing a culture of quality
By: Mary Lou Valdez One of FDA’s most strategic outposts is in India, the seventh largest supplier of food and second largest supplier of pharmaceuticals and biologics to the United States. The agency’s office, located in the capital, New Delhi, works to ensure the safety and security of food and the safety and efficacy of […]
FDA launches Experimental Learning Program
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration is rolling out a new program whereby regulatory staff learn about new and innovative medical device technologies from industry to enhance premarket reviews and other regulatory processes. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
New clinical guidelines for medical devices from Australian TGA
By Stewart Eisenhart, Emergo Group Medical device regulators at the Australian Therapeutic Goods Administration (TGA) have published new guidelines explaining what constitutes acceptable clinical evidence for medical device and IVD manufacturers. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not […]
New medical device rules change India’s Authorized Agent role
By Stewart Eisenhart, Emergo Group The role of in-country representatives for medical device manufacturers registered in India will change substantially under the country’s new Medical Device Rules published earlier in 2017. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not […]
Skin sensors provide insights into how to treat Parkinson’s
A University of Rochester research team is using wearable sensors to indicate the best individualized treatment of Parkinson’s disease. Bernadette Mroz suffers from Parkinson’s. When her medication isn’t working, it makes it hard for her to function. “My world goes into a spin cycle. I cannot function mentally, emotionally or physically,” said Mroz in a […]
This is not a test: RMAT designation goes live
By: Peter Marks, M.D., Ph.D. The field of regenerative medicine encompasses a wide scope of innovative products including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and certain combination products using such therapies. Examples include genetically-modified cellular therapies, such as chimeric antigen receptor T-cells (CAR-T cells) and human tissues grown on scaffolds […]
Medtech stories we missed this week: March 24, 2017
From companies receiving CE marking to other companies adjusting their distribution deals, here are medtech stories we missed this week but thought were still worth mentioning. 1. Viveve Medical closes public offering Viveve Medical announced that it closed its underwritten public offering of 8,625,00 shares of its common stock, according to a March 22 news release. […]
Little or no audit preparation common device QMS problem
By Stewart Eisenhart, Emergo Group In the second in a series of blog posts examining common problems medical device firms deal with related to quality management system audits, Emergo discusses how lack of proper internal audit preparation leads to last-minute scrambles and business headaches. Get the full story here at the Emergo Group’s blog. The […]
Trump proposes higher FDA fees for drug, medical device FDA registrants
By Stewart Eisenhart, Emergo Group US Food and Drug Administration user fee increases in the Trump Administration’s proposed 2018 federal budget would disproportionately impact smaller medical device companies, as these firms make up the majority of the US medical device industry. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]