Boston Scientific Corp. said that three-year primary patency and the four-year freedom from target lesion revascularization (TLR) rate for patients treated with the Ranger drug-coated balloon (DCB), in the Ranger II superficial femoral artery (SFA) study, are the best ever reported data for randomized trials using DCBs.
Vivolta BV raised €7 million ($US7.56 million) in new financing from existing shareholders and the Dutch government to expand its Medispin platform, an automated medical electrospinning production system, for high-throughput manufacturing of tubular electrospun products such as vascular stent grafts and prosthetic heart valves. The funds will also allow the company to continue to evolve into a medical electrospinning contract development and manufacturing organization as it transitions away from an equipment manufacturer.
An artificial intelligence (AI) framework developed by researchers in Denmark has outperformed human emergency call handlers in identifying stroke. The AI tool has the potential to play a critical role in helping to address the number of strokes that go unrecognized as the number of strokes are projected to increase as the population ages.
Avacta Group plc has continued its growth through M&A strategy with the acquisition of Coris Bioconcept Sprl, a developer of rapid diagnostic test kits, for an up-front cash consideration of £7.4 million (US$9.3 million). The Coris deal comes on the back of its £24 million purchase of Launch Diagnostics Holdings Ltd last year, as Avacta works on building up its diagnostics division.
Startup Brightheart SAS raised €2 million (US$2.14 million) in seed financing, from Sofinnova Partners, that will allow the company to accelerate the development of its artificial intelligence software, which helps physicians detect congenital heart defects in fetuses. Brightheart hopes that the technology will improve the detection of complex congenital heart defects during prenatal ultrasound screening as intervening early could address fetal malformations or abnormalities and improve a baby’s chance of survival.
Biosency SA's Bora Care remote monitoring solution can predict acute chronic obstructive pulmonary disease (COPD) exacerbations on average three days prior to hospitalization, according to initial results from an ongoing study. The results show that the technology can help prevent hospital admission and reduce the severity of acute exacerbation of COPD (AECOPD) leading to a better quality of life for COPD patients.
The U.K. government should speed up the approval process for medical devices and strengthen the Medicines and Healthcare products Regulatory Agency, as there is an opportunity for the country to provide global leadership in life sciences regulation in medical devices and medicines on the back of Brexit, according to a report.
Renal denervation (RDN) was described as the “comeback kid” at the recent EuroPCR conference in Paris where participants argued that following the success seen in several sham-controlled trials, there is now no doubt about the safety and the efficacy of the technology as a treatment for hypertension. The device-based procedure should now be used as a therapy option to reduce high blood pressure in patients, delegates heard.
Sequana Medical NV is considering listing in the U.S. as it builds towards the commercialization of its Alfapump, CEO Ian Crosbie told BioWorld in an interview. The company has received a U.S. FDA breakthrough device designation for Alfapump, which treats recurrent or refractory ascites due to liver cirrhosis, and it completed a pivotal study in 2022. The company intends to file the data with the FDA by the end of this year, with the hope of getting premarket approval before the end of 2024.
Robocath SAS is about to embark on a limited market release of its robotic platform, the R-One+, which will not only make performing coronary angioplasties easier and safer but will protect cardiologists from radiation, CEO Lucien Goffart told BioWorld in an interview. However, the launch comes on the heels of a decision by Siemens Healthineers Inc. to discontinue its robotic-assisted endovascular cardiology business as it did not meet the company’s “initial expectations.”
