Cardiovascular Systems says it closed enrollment in the Japanese arm of its coronary orbital atherectomy system trial.
from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/11JMWnt
dilluns, 1 de desembre del 2014
Cardiovascular Systems closes enrollment in Japan arm of atherectomy trial
from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/11JMWnt
Diabetes: FDA approves Animas Vibe with DexCom's G4 Platinum CGM
The FDA grants pre-market approval to Johnson & Johnson's Animas Vibe insulin pump, which uses DexCom's G4 platinum continuous glucose monitoring sensor.
from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1v4YOav
Report: Hackers targeted medtech execs' emails
More than 100 companies, a quarter of them medical device firms, were the targets of a sophisticated hacking operation into their executives' email accounts, according to cybersecurity firm FireEye.
(Reuters) — Security researchers say they have uncovered a cyber espionage ring focused on stealing corporate secrets for the purpose of gaming the stock market, in an operation that has compromised sensitive data about dozens of publicly held companies.
from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1y4ucb5
Patient Safety Journal adjusts after an eye-opening scandal
Kickback allegations against its former editor prompted the Journal of Patient Safety to review his writings and adopt new standards for disclosing commercial conflicts of interest.
Dr. Chuck Denham delivers a keynote address to the Cleveland Clinic in 2011. Denham, once a golden figure in the burgeoning patient safety movement, has faced kickback allegations and now a review of articles he wrote for the Journal of Patient Safety. (SafetyLeaders/Flickr)
by Marshall Allen, ProPublica
from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1rMLDAu
EU allows GI Dynamics EndoBarrier back on the market
GI Dynamics says it can restart sales of its EndoBarrier weight loss device in Europe, having resolved concerns over use guidelines and how it reports adverse events.
from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1yBJacq
South Korean medical device regulators ban some raw materials
The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.
By Stewart Eisenhart, Emergo Group
South Korea's Ministry of Food and Drug Safety (MFDS) identified certain raw materials prohibited from use in medical device production.
from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1zHX3UE
EU regulators clear Medtronic's Covidien buy
Anti-trust regulators in Europe clear Medtronic's $43 billion acquisition of Covidien.
from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1B56MZk
Subscriure's a:
Missatges (Atom)