By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) plans to begin conducting on-site inspections of clinical trials for medical devices in an effort to improve clinical data used in premarket review decisions. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
Gerresheimer launches new syringe safety solutions
Gerresheimer announced that it has acquired an exclusive license from West Pharmaceutical Services to complete its prefillable syringes portfolio with passive syringe safety solutions. “As a result of our long-standing partnership with the leading manufacturer of packaging components and delivery devices for parenteral drugs, we are pleased to have acquired the rights to market this […]
FDA collaborates to promote safety, quality in clinical trials done in India
By Leslie Ball, M.D., Letitia Robinson, Ph.D., R.N, and Elizabeth Wiley, M.D., J.D., M.P.H. After more than 16 hours of travel, we touch down in Mumbai late in the evening and are greeted by a wave of heat and humidity as we exit the airport terminal. As we drive from the airport to the hotel, […]
Two recent scientific advances underscore an encouraging future for precision medicine at FDA
By: Janet Woodcock, M.D. FDA helps bring precision medicine – in the form of targeted therapies — to people living with diseases that have specific genetic features. Two recent FDA drug approvals point to an encouraging future for “precision medicine” — an approach for disease treatment that tailors medical therapies, including medications, to the needs […]
Medtech stories we missed this week: July 14, 2017
From Novarad touting its VR-surgical guidance system to Zynex paying off its $2.2M loan, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Stimwave announces first patient in Brazil Stimwave announced in a July 5 press release that its first patients in Brazil have received Stimwave’s wireless pain relief […]
FDA recognizes UL 2900 cybersecurity standards
By Stewart Eisenhart, Emergo Group A set of standards published by UL to address medical device cybersecurity issues will soon be adopted by the US Food and Drug Administration to help manufacturers support security assurance claims. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
Brazil adds Irish Standards Authority to accredited list of MDSAP auditors
By Stewart Eisenhart, Emergo Group Brazilian medical device regulators have recognized the National Standards Authority of Ireland (NSAI) as accredited to conduct quality system audits under the Medical Device Single Audit Program (MDSAP). Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
India CDSCO draft clarifies medical device, IVD registrations
By Stewart Eisenhart, Emergo Group Indian medical device market regulators have published a new draft list of medical devices that clarifies how they’ll be classified under the new Medical Device Rules 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 […]
How FDA plans to help consumers capitalize on advances in science
By: Scott Gottlieb, M.D. We’re at a point in science where new medical technologies hold out the promise of better treatments for a widening number of vexing conditions. Over the last few decades, science has enabled fundamental advances in our understanding of the genetic and protein bases of human disease. These developments are already being […]
New Canadian medical device incident reporting rules proposals
By Stewart Eisenhart, Emergo Group Canadian healthcare market regulator Health Canada is developing new requirements for certain hospitals to report serious medical device incidents and adverse drug reactions to better protect public health. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]