By Stewart Eisenhart, Emergo Group Medical device market regulators at the China Food and Drug Administration (CFDA) have published new guidance proposing registration requirements for devices produced via 3D printing or additive manufacturing. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
Brain implant for some blind people shows benefits of FDA’s Breakthrough Device Program
Malvina Eydelman, M.D., Director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices, Office of Device Evaluation FDA’s Breakthrough Devices Program is beginning to show important results for patients since it was established in late 2016 under the 21st Century Cures Act to help patients gain timely access to breakthrough technologies. Consider Second Sight […]
Medtech stories we missed this week: March 16, 2018
From Intricon expanding its manufacturing space to Arthrex signing a global distribution deal, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Intricon expands medical footprint Intricon announced in a March 13 press release that it has signed a 5-year lease that will secure 30,000 sq. ft of manufacturing […]
MDSAP certification expanded for Brazilian, South American medical device companies
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has officially extended applicability of the Medical Device Single Audit Program (MDSAP) to domestic manufacturers as well as other companies based in South America. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
Indian CDSCO releases FAQ on medical device rules
By Stewart Eisenhart, Emergo Group The Central Drugs Standard Control Organization (CDSCO), India’s medical device market regulator, has published a new Frequently Asked Questions (FAQ) document to clarify industry questions regarding the country’s new medical device oversight system. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Medtech stories we missed this week: March 2, 2018
From InspireMD’s new distribution deals to Kelynium’s distribution deal with a mystery partner, here are medtech stories we missed this week but thought were still worth mentioning. 1. InspireMD inks distribution deals in Greece, Caribbean InspireMD announced in a March 1 press release that it has signed exclusive distribution agreements with T-Vascular IKE Medical Supplies in […]
FDA plans 2018 update for global UDI database
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration will soon implement updates to its Global Unique Device Identification Database, or GUDID, based on feedback and requests from medical device 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 […]
Eudamed accessibility for medical device regulators outside of Europe
By Ronald Boumans, Emergo Group The European Commission is considering extending access to the Eudamed medical device database to non-European regulators to boost sharing of device safety information, potentially creating a new global data exchange standard for the industry. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]
Attivo Networks receives validation from BD for BOTsink cybersecurity solution
Attivo Networks recently announced that it has received validation through a BD Product Security Partner Program for its BOTsink cybersecurity deception solution when used with BD devices. The company recently expanded its IOT portfolio and the BD collaboration will allow for improved detection capabilities against cyber threats that impact medical devices. The deception-based threat detection […]
Brazil regulators extend Class III and IV medical device, IVD registration validity timeframes
By Stewart Eisenhart, Emergo Group Brazilian medical device regulator ANVISA has extended the validity of higher-risk device and IVD registrations from five to 10 years, a major and auspicious change for manufacturers selling in the country. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]