Switzerland is making moves to allow the import of U.S. FDA-approved medical devices after losing barrier-free access to the EU market and over rising concerns about the dismal pace of implementation of the EU’s upgraded devices regulations.
Uromems SAS reported the successful completion of the first-in-human implant of a smart, automated artificial urinary sphincter (AUS) device for treating stress urinary incontinence (SUI). This initial pilot study recently saw the first male patient implanted with the Uroactive System at Paris’s La Pitié-Salpêtrière University Hospital and is considered by the company to be a key milestone in the technology’s development.
Vaudois University Hospital (CHUV), in conjunction with the European laboratory for particle physics (CERN) and Theryq SAS, has signed an agreement to develop equipment for a novel radiotherapy technique known as “electron Flash therapy.” The new device will use very high energy electron (VHEE) radiation to treat cancers resistant to conventional therapy.
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.
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.
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