By Stewart Eisenhart, Emergo Group Medical device regulators at the China Food and Drug Administration (CFDA) have issued a new provision on its recall process for defective 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 […]
Medtech stories we missed: Feb. 10, 2017
From Glytec partnering to beat diabetes to Biolase, Gramercy Extremity Orthopedics and more getting FDA clearances, here are 7 recent medtech stories we missed this week, but were still worth mentioning. 1. BioTime proposes public offering of common stock Clinical-stage biotechnology company BioTech is intending to offer common stock shares in an underwritten public offering. BioTime focuses […]
Foster Delivery Science and ProMed Pharma partner for drug delivery applications
Foster Delivery Science and ProMed Pharma have partnered commercially for comprehensive contract services for pharmaceutical and combination device applications. The companies plan to offer thermoplastic and silicone formulation development through the production of drug delivery components. Foster Delivery Science offers blending and extrusion of melt processable polymers and active pharmaceutical ingredients like water soluble, bioresorbable and biodurable thermoplastic […]
Missouri University researchers use autograft harvesting to treat chronic wounds
Chronic wound sufferers were able to get skin grafts in an outpatient clinic—all through a Missouri University research team’s work. The researchers used the Acelity Cellutome Epidermal Harvesting System. It is an automated, precise and reproducible process that offers minimal pain and less donor-site trauma. It features suction microsomes that harvest epidermal micrografts automatically, eliminating the […]
New Indian medical device regulations for 2017
By Stewart Eisenhart, Emergo Group The Indian government is planning a significant overhaul of its system for regulating medical devices and IVDs. Emergo is still analyzing the new Medical Device Rules 2017 to determine how the new regulations will affect registration requirements in India, but we can now report on some general points found in […]
Brazilian regulators drop medical device fees
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulators plan to officially reduce registration and quality inspection fees for medical device companies after the country’s Ministry of Finance attempted to push through a hefty increase of those fees in 2015. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
Brazilian regulators add two firms to MDSAP medical device quality inspection program
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has added two more firms to its list of accredited inspectorsfor 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 do not necessarily reflect […]
New medical device rules from Indian regulators
By Stewart Eisenhart, Emergo Group India’s Ministry of Health and Family Welfare has released long-awaited new medical device and in vitro diagnostic (IVD) regulations that take effect in January 2018. 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 […]
Continuous glucose monitoring lowers blood sugar, Swedish study says
A new study from the Sahlgrenska Academy at the University of Gothenburg in Sweden has shown that there was a significant decrease in blood sugar levels and an increased well-being for people with type 1 diabetes over time with the use of a continuous glucose monitor. The study included 161 people with an average age […]
5 key takeaways from Emergo’s medical device industry outlook
By Stewart Eisenhart, Emergo Group Emergo’s latest survey of more than 3,000 medical device industry participants finds renewed focus among companies on US and European markets, as well as more bearish expectations for BRIC markets and greater challenges addressing regulatory compliance. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
