Stimvia s.r.o. recently secured Medical Device Regulation certification for its Uris neuromodulation system to deliver both percutaneous tibial nerve stimulation and peroneal electrical transcutaneous neuromodulation to treat lower urinary tract symptoms.
Microbiotica Ltd. is poised to advance two of its microbiome-derived products into the clinic after securing regulatory approval and fresh finance. The first live bacterial therapeutic, MB-097, will be tested in combination with Keytruda (pembrolizumab) in patients with advanced melanoma who have not responded to treatment with immune checkpoint inhibitors. The second product, MB-310, is a once-daily oral therapy for treating the inflammatory bowel disease, ulcerative colitis.
In what represents the first patenting from Munich, Germany-based Meliodys Medical UG, its co-founder and chief executive officer Simone Sabbione describes their development of a hormone-free, local pain management approach for treating dysmenorrhea, which aims to address the condition while minimizing the occurrence of side effects.
Vitestro Holding BV received CE marking for its automated blood drawing device which uses artificial intelligence, ultrasound-guided imaging and robotics to ensure accurate and secure blood collection. The device is the first of its kind to achieve CE mark and the company believes it will be transformational for health care.
Medtronic plc hit a sweet spot with its diabetes devices, with the unit leading the company in growth in its first quarter 2025 results. Diabetes device sales grew 11.8% to $647 million for the quarter, an important boost that pushed total revenue up to $7.9 billion ($8.01 billion, adjusted), a 2.8% reported increase or 5.3% exchange rate impact. No other unit saw more than single-digit increases in sales.
The U.K. Medicines and Health Care Products Regulatory Agency enacted its AI Airlock program for artificial intelligence – the agency’s branding for its regulatory sandbox for this type of medical software.
Andera Partners involvement in a string of recent deals in the cardiovascular space demonstrates the ongoing appetite for devices to treat heart diseases, Olivier Litzka, a partner at Andera Partners told BioWorld.
The $180 million Caresyntax GmbH recently raised in a series C extension round allows the company to accelerate the commercialization and adoption of its precision surgery platform, Bjorn von Siemens, CFO and CBO of Caresyntax told BioWorld.
The first patenting from Hemeo BV describes its development of Vantage, an artificial intelligence powered clinical decision support software for coagulation management.
Stereotaxis Inc. Genesisx received the greenlight from the EU authorities for its next generation robotic system, which it says builds on the benefits and performance of the previous Genesis while greatly reducing its barriers to adoption.
RSS
