Phillips-Medisize, a Molex company, said today that it has expanded the FDA-compliant manufacturing capacity of its Little Rock, Ark. plant. The 380,000-square-foot facility is now fully compliant with the Current Good Manufacturing Practice (CGMP) regulations (21 CFR part 820) enforced by the FDA. The plant can now be used for Phillips-Medisize’s medical manufacturing services, including […]
NuVasive touts results of PEEK implant study
NuVasive (NSDQ:NUVA) today announced the results of a study that showed its Cohere porous polyetheretherketone (PEEK) implant improved early outcomes over structural allograft and smooth PEEK in anterior cervical discectomy and fusion (ACDF) procedures. In the study of 167 patients with degenerative cervical disc disease, those who underwent ACDF using Cohere porous PEEK exhibited significant […]
MedTech Europe warns of device flight to U.S. and China if MDR not ready
Europe’s medical device trade group is again warning the European Commission that its new Medical Device Regulation (MDR) system will not be ready by its 2020 deadline and that E.U. medtech companies are taking their business elsewhere as a result. In an open letter to Jyrki Katainen, the commission’s vice president for jobs, growth, investment and competitiveness, […]
FDA bans Boston Sci, Coloplast sales of pelvic mesh
The FDA has ordered Boston Scientific (NYSE:BSX) and Coloplast — the only remaining companies that sell pelvic mesh in the U.S. — to immediately halt sales and distribution of those products. The two companies have not demonstrated a “reasonable assurance of safety and effectiveness for these devices” used to treat pelvic organ prolapse (POP) since the […]
Egypt fast-track medical device registration pathway speeds up market access timeframes
By Stewart Eisenhart, Emergo Group A fast-track premarket review pathway for some medical devices in Egypt is yielding substantially reduced time to market for qualifying 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 necessarily reflect those of MassDevice.com […]
Glaukos touts 5-year study of glaucoma stents
Glaukos (NYSE:GKOS) said today that a study of its iStent trabecular micro-bypass stents reduced eye pressure in glaucoma patients five years after implant. The same study showed that significantly fewer iStent patients needed add-on medications after five years, the company said. The study showed that newly diagnosed, primary open-angle glaucoma (POAG) patients who received two […]
U.K. government requests Brexit deadline extension
By Ronald Boumans, Emergo Group The U.K. government has requested a further delay in implementing its withdrawal from the European Union, with an April 12 deadline for a no-deal Brexit outcome fast approaching. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
EO plant shutdown leads to pediatric breathing tube shortage
The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA. The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of April 22, according to […]
Canadian regulators clarify changes in qualifications for medical device licenses following Sterigenics shutdown
By Stewart Eisenhart, Emergo Group Canadian medical device regulator Health Canada has issued a clarification on which changes to Medical Device License (MDL) holders’ sterilization processes constitute “significant changes” following the closure of a major sterilization facility in the US earlier in 2019. Get the full story here at the Emergo Group’s blog. The opinions […]
5 digital health startups you need to watch in 2019
Funding for digital health companies continues to rise, with 2018 the biggest year so far this decade, according to healthcare investment firm StartUp Health. Investors took a greater interest in machine learning, blockchain and artificial intelligence (AI). Digital health funding was 14 times greater than it was eight years ago, when New York-based StartUp Health began […]
5 issues for medical device risk management and design controls
By Mark Leimbeck, Emergo Group Medical device design and development processes in the context of risk management require careful consideration and planning by manufacturers. Following our webinar in early 2019, we explore five key issues companies face when linking design and development with risk management and, ultimately, patient safety. Get the full story here at […]
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