The California Life Sciences Assn. and PricewaterhouseCoopers released their annual Life Sciences Industry Report, highlighting continued growth and a robust pipeline of medical devices and other therapies in California this year. California, which is ranked 1st for medical device and biopharmaceutical employment in the country, saw 7% employment growth in the sector between 2011 and 2015. […]
The ECRI Institute today released a top 10 watch list for innovations that are “molding the landscape of healthcare in 2016 and beyond,” placing mobile stroke units, medical device cybersecurity and wireless wearable sensors at the top. The list is meant to highlight important new or emerging issues in healthcare with intentions of improving safety […]
(Reuters) – A new wave of wearable computing devices that detect and monitor serious diseases is moving from the laboratory to the market, potentially transforming the treatment of conditions ranging from epilepsy to diabetes and creating business opportunities estimated to be worth tens of billions of dollars. Unlike popular fitness-tracking devices, such as Fitbit Inc’s […]
GE Healthcare (NYSE:GE) today said it is launching a new $300 million “Sustainable Healthcare Solutions” business that will be focused on low-cost, high-value technology for emerging markets. The newly created division is part of a multi-phase effort by the company to expand its healthcare portfolio and will combine GE Healthcare’s operations in Africa, India, south Asia and […]
By Stewart Eisenhart, Emergo Group An effective medical device distribution plan for the Middle East requires appreciation for business culture and practices unique to the region, as well as for distinct market characteristics for countries such as Turkey, the Kingdom of Saudi Arabia and Egypt. In this podcast, Emergo Managing Director for the Middle East […]
Researchers at Vanderbilt University announced last week that they developed a surgical robot with steerable needle equipped with wrists smaller than 2 mm thick for use during micro-laproscopic, or needlescopic, surgeries. The device is designed to provide greater dexterity to the microscopic tools, something they currently lack. The new wrists would allow surgeon-operators to perform […]
By Stewart Eisenhart, Emergo Group South Africa’s Department of Health has released new draft regulations for medical devices and IVDs that accompanies proposed rules issued by the government in 2014.
By Stewart Eisenhart, Emergo Group Russian medical device market regulators have eased registration and market entry requirements for low-risk Class I devices, while at the same time formalizing procedures for certain registration amendments and changes to Instructions for Use (IFU).
By Stewart Eisenhart, Emergo Group Although the European Union has a uniform process, CE Marking, in place to allow registration and marketing of medical devices across all member states, distribution of devices requires regional expertise. In this Emergo podcast, we explain how to identify and vet European device distributors. Edgar Kasteel, Senior Manager at Emergo’s […]
By Stewart Eisenhart, Emergo Group The Australian Therapeutic Goods Administration (TGA) has officially ended the three-year transition period for manufacturers of certain joint replacement devices to apply for reclassification of their products from Class IIb to Class III.
By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) will begin a new program of unannounced inspections beginning September 1, 2015 for medical device manufacturers registered to market their products in the country.