A French surgical team has performed a robot-assisted kidney auto-transplantation with ex situ tumorectomies for renal cell cancer. This is the world first use of the fourth generation Da Vinci Xi surgical robot from Sunnyvale, Calif.-based Intuitive Surgical Inc. to perform kidney explanation and autotransplantation with removal of multiple and complex tumors outside of a patient's body.
Bringing notified bodies (NBs) into a med-tech regulatory system has proven to be no mean feat in the European Union, but the U.K. Medicines and Health Care Products Regulatory Agency (MHRA) seems not to suffer from such impediments. The agency just added several in vitro diagnostic (IVD) technological areas to the roster of tests that can be reviewed by UL International UK, an addition that will help ensure patients can obtain the tests they need.
Perspectum Diagnostics Ltd. reported the first close at $36 million of its series C round, with the majority of the new money due to be invested in expanding U.S. uptake of its Livermultiscan diagnostic for assessing and monitoring chronic liver disease.
Volta Medical SAS reported raising $39 million in a series B round to roll out its VX1 software mapping system in Europe and the U.S. This artificial intelligence (AI) algorithm is compatible with most readily available multi-polar catheters and technology used in operating rooms and cath labs in the treatment of complex cardiac arrhythmia.
French consortium Booster is developing a personalized emergency treatment of ischemic stroke in its work on brain clot personalized therapeutic strategies for stroke emergent reperfusion. The aim is to refine the patient prognosis based on blood clot clinical and radiological characteristics and propose more effective drug treatments with a new generation of intracranial stents.
The European Commission (EC) has proposed to extend compliance deadlines under the Medical Device Regulation (MDR) to 2027 for high-risk devices and to 2028 for low- and moderate-risk devices, seemingly providing some critical breathing room for manufacturers and patients alike. However, the proposal requires that manufacturers have an application on file for their legacy device by May 2024, suggesting that manufacturers will still face a crippling backlog in obtaining contracts with notified bodies to process these applications.
A surgical team from the Curie-Montsouris Chest Center in Paris, has successfully performed thermal ablation of a metastatic lung lesion using microwaves via a computer tomography (CT)-guided endobronchial approach.
Bottneuro AG closed the first tranche of a bridge round, bringing its total capital raise in 2022 to $4.3 million. This is being used to develop its noninvasive, domestic therapy for treating early moderate-stage Alzheimer’s patients.
The U.K. Medicines and Healthcare products Agency (MHRA) reported a trio of research projects as part of a push to maintain its reputation as a leading regulator of drugs and medical devices now the U.K. is no longer part of EU regulatory systems, and to attract clinical trials - and the associated inward investment - despite no longer offering access to the EU single market.
Onward Medical NV reported clinical outcomes for the first 10 patients given therapy to regulate blood pressure using its implantable ARC technology. This pulse generator produced an immediate improvement in blood pressure regulation in all study participants.
