FDA Approves Cardiac Dimensions Trial for Heart Valve Repair Device December 1, 2016 The device is designed to redirect the blood flow into the heart. Read More
French Regulators Order Freeze on Carmat December 1, 2016 Carmat claims that the artificial heart was not linked to the death. Read More
Abbott Gains CE Mark For i-STAT Alinity System November 30, 2016 Results are delivered in two to 10 minutes. Read More
Quidel’s Solana(R) Molecular Assay Achieves FDA Clearance November 30, 2016 Solana can process up to 12 patient samples in each run. Read More
ConvertX Nabs FDA Clearance for Kidney Stent System November 30, 2016 The device is implanted and converts from a catheter to a stent. Read More
FDA Approves Rodo Abutment System November 30, 2016 The combination device eliminates the need for cement or screws. Read More
Cynosure Receives China FDA Clearance for Icon Aesthetic System November 29, 2016 Cynosure will begin selling Icon late this year. Read More
French Medical Device Regulators Have Posted New Rules for CE Approval November 29, 2016 Companies denotified will no longer able to apply for marketing extensions. Read More
Russian Regulators Have Updated Qualifying List of Implantable Medical Devices November 29, 2016 Russian regulators update implantable medical device list. Read More
The 21st Century Cures Act Set for House Vote Today November 29, 2016 This act is designed to speed up FDA approval of new devices. Read More
EU Antitrust Regulators Grant Conditional Approval for Abbott’s $25B St. Jude Medical Purchase November 28, 2016 The deal requires the exchange of a pair of device lines. Read More
SyntheticMR Introduces REMyDI November 28, 2016 REMyDI is a feature of the SyMRI post-processing software from SyntheticMR. Read More