While NASA gets the glory for exploration of the vast unknown of space, Bionaut Labs Ltd. hopes to reap similar fame by transforming travel through the brain with Bionauts, microrobots designed to deliver therapeutic payloads across the blood-brain barrier. To help achieve that mission, the company raised $43.2 million in a series B financing round led by Khosla Ventures. Read More
The angst over the maladroit roll-out of the European Union’s Medical Device Regulation (MDR) has reached the European Parliament (EP), which met recently to address the issue. Stella Kyriakides, who oversees the MDR on behalf of the European Commission (EC) responded to stinging criticism from the EP that the EC’s health council will meet in December to address both the short-term and structural problems with the MDR, but had little detail to offer other than a promise to keep the EP abreast of these developments. Read More
Endologix LLC reported 12-month results from the second of two studies of a fully percutaneous, transmural arterial bypass therapy for treating peripheral arterial disease. Presented at this month's annual Vascular Interventional Advances Conference in Las Vegas, the Detour-2 study revealed technical success in 100% of treated patients using the system which also surpassed a 30-day, major adverse event rate of just 7%.” Read More
The U.S. FDA posted an update to the ongoing recall of respirators and positive airway pressure devices by Philips Respironics Inc., a subsidiary of Amsterdam-based Royal Phillips NV, which are associated with more than 21,000 medical device reports (MDRs) between Aug. 1 and Oct. 31, 2022. However, these MDRs are also associated with 91 patient deaths, which while they cannot be attributed directly to these devices, are nonetheless a stain on the reputation of the company’s products going forward. Read More
Enzyre BV reported closing a $12.5 million series A round to ramp development of its micro diagnostics platform used for monitoring blood coagulation status at home. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Boston Scientific, Edwards, Ikonopedia, Ultrasight. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alphabet, Bialogics, Blackford, GE Healthcare, Google Health, Halo Diagnostics, Heartvista, Icad, Ikonopedia, Inqb8 Medical Technologies, Peijia Medical, Radnet, Ulrich, Vist.ai. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anteris, Seekin. Read More
