Surgibox Inc. won a CE mark for two components of its Surgifield system, an ultraportable sterile system that enables safe surgery any place, any time. The five-year-old startup also landed a humanitarian use exemption for use of the system in war-torn Ukraine.
The U.K. National Institute for Health and Care Excellence has expanded its endorsement for the Greenlight XPS system for benign prostatic hyperplasia to no longer exclude patients deemed at high risk for hemorrhage, a decision that may boost utilization and thus sales of the XPS.
Meccellis Biotech Group SAS reported closing an $8.25 million series B funding round to launch its biological implant technology on the US market. The exercise was supported by investment worth $5 million from Ocean Participations SAS alongside new funds from Volney Development SAS, Nouvelle-Aquitaine Co-Investissement SAS and the Poitou-Charentes business angel network Synergence Invest SAS.
The U.K. Bioindustry Association (BIA) is in an eleventh hour fight against changes to R&D tax breaks that it estimates will result in a £400 million to £800 million (US$480 million to $960 million) cut in payments to the sector. The changes will see cash credit claims reduced from 14.5% to 10%, cutting payments from 33 pence per £1 of spend to 18.6 pence per pound of spend from April 2023. Along with other tweaks, this is an effective 50% cut for biopharmas that do not pay any corporation tax because they are loss-making.
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 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.
After shelving it for the past decade, the EU Parliament this week adopted a directive forcing large publicly listed companies to break the glass ceilings that have allowed a men-only mentality to thrive in corporate boardrooms across much of Europe. The so-called Women on Boards Directive, formally adopted Nov. 22, will require EU-based public companies to have women in at least 40% of their nonexecutive director posts or 33% of all director posts by the end of June 2026. Companies with fewer than 250 employees will be exempt.
Mdoloris Medical Systems SAS and Pprs SAS reported a joint venture to launch ANI Guardian, a connected medical device that continuously and non-invasively tracks pain levels and well-being in a range of non-verbal or cognitively impaired people.
After shelving it for the past decade, the EU Parliament this week adopted a directive forcing large publicly listed companies to break the glass ceilings that have allowed a men-only mentality to thrive in corporate boardrooms across much of Europe. The so-called Women on Boards Directive, formally adopted Nov. 22, will require EU-based public companies to have women in at least 40% of their nonexecutive director posts or 33% of all director posts by the end of June 2026. Companies with fewer than 250 employees will be exempt.
Shanghai Junshi Biosciences Co. Ltd. has submitted a new drug application (NDA) for its anti-PD-1 monoclonal antibody toripalimab to the European Medicines Agency, which marks the first NDA filing of toripalimab in Europe.
RSS
