By Stewart Eisenhart, Emergo Group US Food and Drug Administration user fees for medical device registrations including 510(k) and Premarket Approval (PMA) applications will increase for the agency’s 2019 fiscal year at a much slighter rate than for 2018. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]
Analysis: Global medical device regulatory trends
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 […]
Medtech stories we missed this week: July 27, 2018
From the FDA clearing LifeSignal’s wireless ECG to Zavation receiving FDA clearance for its expandable corpectomy cage, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears LifeSignal’s wireless ECG LifeSignals announced in a July 26 press releasethat it has received FDA clearance for its wireless LP1100 Life Signal […]
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 […]