By Evangeline Loh, Emergo Group In the past half year (January through June 2018), Emergo has observed data to support two global trends: Initiatives to enhance device tracking and traceability, and simplification of the regulatory process for the lowest-risk medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
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China FDA adds more medical devices, IVDs to clinical trial exemptions list
By Teemo Chang and Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) has drafted a new batch of medium- and high-risk medical devices and IVDs slated for exemption from clinical trial requirements in the country. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
This engineered heart ventricle helps with studying arrhythmia and cardiomyopathy
While engineered heart tissues can replicate muscle contraction and electrical activity in a dish, many aspects of heart disease can only adequately be captured in 3D. In a report published online yesterday by Nature Biomedical Engineering, researchers describe a scale model of a heart ventricle, built to replicate the chamber’s architecture, physiology and contractions. Cardiac […]
Adhesive respiratory monitor detects breathing problems early
Children can be at risk for compromised breathing after surgery or from conditions like asthma, congestive heart failure or sleep apnea. Opioid therapy and sedation for medical procedures can also depress breathing. Unless a child is sick enough to have a breathing tube, respiratory problems can be difficult to detect early. Yet early detection can […]
ETV/CPC show positive outcomes in babies with hydrocephalus
Hydrocephalus, literally “water on the brain,” is an abnormal build-up of cerebrospinal fluid in the brain cavities known as ventricles. In infants, it can be congenital (it often accompanies spina bifida, for example), or it can be caused by brain hemorrhage or infection. The usual treatment is surgery to implant a shunt, which drains the […]
Australia TGA to change Prostheses List publication schedule starting in 2019
By Stewart Eisenhart, Emergo Group The Australian Department of Health will begin publishing its Prostheses List of prosthetic medical devices more frequently starting in 2019 in an effort to address patient access and manufacturer reimbursement issues. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
China FDA accepting MDCO certificates from Hong Kong-based medical device registration applicants
By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) has begun recognizing certain certifications issued by the Hong Kong Medical Device Control Office (MDCO) for country-of-origin requirements. 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 […]
Swiss regulators to overhaul export certification system
By Stewart Eisenhart, Emergo Group Swissmedic, Switzerland’s medical device market regulator, will replace its current processes for issuing export certificates as well as manufacturing certificates with an online system in order to prevent delays and free up resources. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Proposed medical device regulatory changes to Order No. 650 in China
By Teemo Chang and Stewart Eisenhart, Emergo Group The Chinese government has issued draft changes to the country’s medical device regulatory framework that would allow easier market access for foreign 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 […]
How medtech can prepare for the consequences of a “Hard Brexit”
By Ronald Boumans, Emergo Group On July 5, the Dutch Ministry of Health organized an informative meeting for the medical field about the possible impact the UK’s exit from the European Union (EU), Brexit, might have. This is considered a very important issue that may impact many aspects of the Dutch – and European – […]