While NASA gets the glory for exploration of the vast unknown of space, Bionaut Labs 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. Joining Khosla, which also led the company’s $20 million series A in March 2021, were new investors Deep Insight, Ourcrowd, PSPRS, Sixty Degree Capital, Dolby Family Ventures, GISEV Family Ventures, What if Ventures, Tintah Grace and Gaingels. All previous investors – Upfront Ventures, Bold Capital Partners, Revolution VC and Compound –  also returned for the round.

European Commission eyes a new set of fixes for device shortages under MDR 

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.

Transmural arterial bypass therapy system performs well according to 12-month clinical study

Clinical results have been released from the second of two clinical studies of a fully percutaneous, transmural arterial bypass therapy for treating peripheral arterial disease. Developed by Irvine, Calif.-based Endologix LLC and 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%.

Enzyre raises $12.5M for home blood clotting microlab ramp

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. The round was led by new investor Oost NV from Apeldoorn in the Netherlands. Luxembourg-based venture capital firm I&I Biotech Fund I SCSp, and Demcon Advanced Mechatronics Enschede BV from the Netherlands, also participated in this round, alongside existing investors Takeda Ventures Inc., based in Palo Alto, Ca, and Novalis Biotech Fund, an early stage life sciences venture capital investor from Ghent, Belgium. Part of the funding comes from an innovation grant from the Dutch government.

MDR numbers for Philips respirators continue to track upward

The U.S. FDA posted an update to the ongoing recall of ventilators and positive airway pressure devices made by Philips Respironics, which are associated with more than 21,000 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 company’s products going forward.

Holiday notice

BioWorld's offices were closed in observance of Thanksgiving in the U.S. No issues were published Thursday, Nov. 24, or Friday, Nov. 25.

Also in the news

Anteris Technologies, Bialogics, Blackford, Boston Scientific, Edwards, Feinstein Institutes, GE Healthcare, Google Health, Halo Diagnostics, Heartvista, Icad, Ikonopedia, Inqb8 Medical Technologies, Nyra Medical, Peijia Medical, Radnet, Seekin, SQI Diagnostics, Temedica, Ulrich Medical, Ultrasight