Merit Medical Systems Inc. received a U.S. FDA breakthrough device designation for its Scout MD surgical guidance system, which enables physicians to pinpoint tumor location in soft tissue. The system uses up tiny reflectors to provide multidimensional location data that can improve the ability to remove the entire tumor with minimal trauma to the surrounding tissue, which can be a challenge in surgeries such as lumpectomies. Read More
The U.S. FDA’s 2018 program for voluntary malfunction summary reporting (VMSR) was intended to ease the burden for both industry and the agency regarding low-risk malfunctions associated with a limited set of device types. However, a new draft guidance on the subject drew criticism from two trade associations for being administratively cumbersome, suggesting the guidance will need considerable cleaning up before presentation in final form. Read More
Avicenna.AI SAS secured a further $7.5 million in series A funding, bringing the total aggregated investment in the company so far to $10.4 million. The round was backed by the two existing Paris-based investors: Cemag Invest SAS and Innovacom Gestion SAS. “Thanks to this funding, we are now able to ramp deployment of our software platform around the world, as well as diversify our offering into new areas of medicine,” Cyril Di Grandi, CEO and co-founder of Avicenna.AI SAS, told BioWorld. Read More
Hygea Medical Technology Co. Ltd. has completed a series D funding round to develop an integrated platform for interventional oncology procedures and expand globally. Read More
To restore hearing function in patients with hearing loss or deafness, cochlear implantation is seen as the only method that works, but insertion of the electrode array may cause direct mechanical injury to the cochlea, with the subsequent loss attributed to an inflammatory response driven by proinflammatory cytokines, reactive oxygen species and apoptotic signals. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: EDX Medical Group, Minerva Surgical, Torax Biosciences, Hologic, Lunit. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Merit Medical, Terumo Blood and Cell. Read More
