A variety of governmental entities in the EU are feeling pressure to address the issues with the rollout of the Medical Device Regulation, and some EU member states have taken matters into their own hands.
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.
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.
Vitadx SA is preparing to close a new $8.3 million funding round, to ramp European distribution of its automated software platform for early detection of bladder cancer. The system is based on morphology analysis of cells in a urine sample on a digital cytology slide. “Our Visiocyt technology allows urologists to adjust patient pathways and thereby limit the number of invasive procedures necessary to confirm their diagnosis with people already presenting symptoms,” Allan Rodriguez, CEO and co-founder of Vitadx, told BioWorld.
Sema4 Holdings Corp., Illumina Inc. and Pear Therapeutics Inc. joined a growing list of med-tech companies responding to what Pear CEO Corey McCann called a “challenging macroenvironment” by spinning off, selling or shuttering non-core lines of business and slimming payroll.
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