HONG KONG – Fujifilm Corp. has entered an agreement with Hitachi Ltd. to acquire Hitachi Ltd.’s diagnostic imaging-related business to further expand Fujifilm’s health care business. Prior to the acquisition, Hitachi will found a new company and implement an absorption-type company split whereby the new company will absorb the business. Read More
Dublin-based Medtronic plc reported Wednesday that the U.S. FDA has given the green light to its Stealth Autoguide system. The company said it is the first cranial robotic platform that integrates with its enabling technology portfolio to create an end-to-end procedural solution. Read More
The European Parliament this week formally agreed to delay the requirement for certain currently approved class 1 medical devices to comply with the new Medical Device Regulation (MDR) when it comes into force on May 26, 2020. Consequently, manufacturers of reusable surgical instruments and devices that have a measuring function will have an additional four years to meet the stricter requirements of MDR. Read More
DUBLIN – Truffle Capital closed off its fifth Biomedtech fund with a €250 million (US$279 million) raise, which it will deploy in about a dozen companies located mainly in France. The fund took a little longer to close than originally planned but it is significantly larger than it had originally intended. “Our initial objective was €200 million,” Truffle Capital CEO and co-founder Philippe Pouletty told BioWorld MedTech. Read More
Heart failure is a leading cause of disability and death in the U.S., but many cases are diagnosed late due to limited access to echocardiography, the primary method of detecting the condition. To address that need, the U.S. FDA has granted breakthrough device designation to Eko Devices Inc., of Berkeley, Calif., for an electrocardiogram (ECG)-based algorithm that could serve as an easily accessible screening tool for heart failure during routine physical exams. Read More
