Cytori Therapeutics (NSDQ:CYTX) said today that the FDA approved an Investigational Device Exemption for a pilot trial of the company’s cell therapy in patients with thermal burn injury. The Relief trial is a part of Cytori’s ongoing R&D efforts under its contract with the U.S. Dept. of Health & Human Services’ Biomedical Advanced Research and […]
Regulatory/Compliance
European Parliament approves new medical device, IVD regulations
By Stewart Eisenhart, Emergo Group The European Parliament has officially voted to approve the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR), allowing implementation efforts for these major new regulations to proceed. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
After review of patient deaths, European regulators OK Actelion’s Uptravi
The European Medicines Agency told doctors today that they can continue to prescribe Actelion‘s (VTX:ATLN) pulmonary arterial hypertension drug, Uptravi. The regulatory body initiated a safety review in January after 5 patients in France died and docs were asked to stop prescribing the drug. Regulators reported that their review did not suggest an increase in mortality […]
MFDS launches new medical device recall system in South Korea
By Stewart Eisenhart, Emergo Group The South Korean Ministry of Food and Drug Safety (MFDS) has rolled out a new system for medical devices subject to recalls in the country. 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 […]
Saudi Food and Drug Authority plans changes for medical device marketing application
By Stewart Eisenhart, Emergo Group Saudi Arabia’s medical device regulator, the Saudi Food and Drug Authority (SFDA), plans to introduce changes to the application process for obtaining market authorization in the country. 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 […]
Singapore changes medical device field safety notice requirements
By Stewart Eisenhart, Emergo Group Singapore’s medical device market regulator now requires registrants issuing field safety notices (FSNs) regarding their products to copy managers of affected local healthcare facilities. 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 […]
More trouble for United’s Remodulin
The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office ruled yesterday that the claims of United Therapeutics‘s (NSDQ:UTHR) patent, which covers Remodulin, are unpatenable due to obviousness. SteadyMed (NSDQ:STDY) challenged the patent in October last year. The patent, No. 8,497,393, relates to the process to purify prostacyclin derivatives, including treprostinil, which is […]
Reva Medical wins CE Mark for Fantom bioresorbable scaffold
Reva Medical (ASX:RVA) said yesterday that it won CE Mark approval in the European Union for its Fantom sirolimus-eluting bioresorbable coronary scaffold. The Fantom scaffold is the San Diego, Calif.-based company’s 1st commercial product. Reva said it plans to begin selling the product in Europe this quarter. “CE Mark approval for Fantom is a major milestone for […]
Russian technical file requirements for medical devices and IVDs clarified by regulators
By Stewart Eisenhart, Emergo Group The Russian Ministry of Health has issued a new regulation to explain longstanding but unofficial technical file and instructions for use requirements for medical device and IVD registrants. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
Medtech stories we missed this week: March 31, 2017
This week we saw a few FDA 510(k) clearances and one of the 1st uses of a next-generation surgical robot in Asia. Here are medtech stories we missed this week but thought were still worth mentioning: 1. Corindus touts first Asian use of next-generation robot Corindus Vascular Robotics announced in a March 31 press release that robot-assisted […]
