From new and renewed partnerships to FDA approvals, here are medtech stories we missed this week but thought were still worth mentioning. 1. Life Spine receives FDA clearance for cervical spacer system Life Spine announced in an April 19 press release that it has received FDA 510(k) clearance for its Plateau-C Ti Cervical Spacer System. The system uses […]
6 ways hydrogels are enabling medtech innovation
Hydrogels are water-based biomaterials developed specifically for human use, according to a Biomaterials journal article. They are a water-swollen polymeric material that doesn’t change its distinct 3D structure. They are formed from super-absorbent, chain-like polymers and are not soluble in water. However, their porous surface allows for nutrients and cell waste to pass through. They have shown the […]
Malaysian combination product regulatory policy deadlines set
By Stewart Eisenhart, Emergo Group Malaysian medical device and drug market regulators have established a July 2018 implementation and enforcement deadline for combination product registrations marketed in the country. 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 necessarily reflect […]
Brexit effects on Authorized Representatives in EU and UK
By Ronald Boumans, Emergo Group On 29 March 2017, the United Kingdom’s ambassador to the European Union delivered a formal letter invoking Article 50 of the Treaty of the EU to the President of the European Council. This means the UK will leave the European Union in two years at the latest. The date of […]
IMDRF wants to harmonize terminology for adverse event reporting
By Stewart Eisenhart, Emergo Group The International Medical Device Regulators Forum (IMDRF) has published a final draft of proposed terminologies for harmonized adverse event reporting for medical devices and IVDs. 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 necessarily […]
America’s Got Talent – regulatory science style
By: Stephen Ostroff, M.D. Veni Vidi Vici. It translates into English as “I came, I saw, I conquered.” It also happens to be the name chosen by one of the winners of the recently held America’s Got Regulatory Science Talent Competition. FDA recognizes that young scientists are our future. Now in its fifth year, America’s Got Regulatory […]
Medtech stories we missed this week: April 14, 2017
From FDA approvals to business expansion plans, here are medtech stories we missed this week but thought were still worth mentioning. 1. BioTelemetry launches offer to acquire LifeWatch BioTelemetry and LifeWatch announced in an April 9 press release that the 2 companies have entered a transaction agreement that states BioTelemetry will launch a tender offer to acquire all […]
‘Organs-on-Chips’ technology: FDA testing groundbreaking science
By: Suzanne Fitzpatrick, Ph.D. There are many things you might envision putting on a chip. It’s unlikely that a human organ is one of them. But creating human organ systems in miniature on micro-engineered chips about the size of a AA battery is a revolutionary testing technology that has captured the attention of food scientists […]
10 questions companies affected by European MDR should be asking
By Ronald Boumans and Stewart Eisenhart, Emergo Group Now that the European Parliament has voted to approve the Medical Device Regulations (MDR), many medical device companies active in Europe have begun mapping out how the new Regulations will impact their business. Based on feedback from clients as well as our own analysis of the MDR, […]
China FDA getting rid of medical device testing fees
By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) appears to have stopped charging substantial fees for in-country registration testing of medical devices. 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 necessarily reflect those of DrugDeliveryBusiness.com […]