CryoCor begins AF (atrial fibrillation) cryotherapy trial:
This article was originally published in Clinica
The US FDA has given CryoCor the go-ahead to begin a feasibility study of its minimally invasive cardiac cryoablation system for treating atrial fibrillation (AF). The study will involve around 30 patients at up to five centres and will assess the San Diego, California firm's system, called CryoCor, as a treatment for paroxysmal, or intermittent, AF. Patient follow-up of the trial is scheduled for completion by the fourth quarter of 2002, after which CryoCor plans to file for FDA approval to begin a pivotal US trial to support a marketing application for the device. The device has yet to be CE-marked for sale in Europe.
You may also be interested in...
A reagent in a batch of COVID-19 tests shipped by the US Centers for Disease Control and Prevention to state laboratories “wasn’t performing consistently,” a top CDC official says, so the agency is reformulating it – slowing down the labs’ ability to use the diagnostic, which yielded inconsistent results when quality-tested. But waiting in the wings are commercial coronavirus test kits being developed by Qiagen and Cepheid; both firms say they’ll submit the kits to the FDA for emergency-use approval.
OIG will focus on successful drugs that have been repurposed as orphans, noting nine of the 10 top selling drugs have both orphan and non-orphan indications.
Switzerland’s SIX exchange-listed drug development company, Basilea, is moving two new oncology candidates along its R&D pipeline, supported by strong revenues from two partnered anti-infective products.