Elixir Medical Corp. reported positive 12-month data from the Infinity-Swedeheart trial that compared its Dynamx coronary bioadaptor system to Medtronic plc’s Resolute Onyx zotarolimus drug-eluting stent in patients requiring percutaneous coronary intervention with coronary artery disease.
CMR Surgical Ltd. recently submitted its application to the U.S. FDA for approval for its Versius surgical system as it seeks to get more surgeons using the small, portable, robotic tool in laparoscopic procedures.
Researchers developed a new method using light to analyze crystals in dry blood samples to detect prostate cancer early. The scientists employed a polarization-based image reconstruction technique which demonstrated an accuracy rate of more than 90% in both the early diagnosis and classification of cancer.
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.
Siemens Healthineers AG made a binding offer to Novartis AG, of Basel, Switzerland, to acquire its Advanced Accelerator Applications Molecular Imaging business which includes the European manufacturing and distribution network of diagnostic radiopharmaceuticals for positron emission tomography scans.
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.
The clearance by the U.S. FDA of Healthccsng V2.0, an artificial intelligence cardiac solution developed by Nano-x Imaging Ltd.’s (Nanox) subsidiary, Nanox.AI, is highly “significant” for the company and will offer “substantial” benefits to cardiology departments by significantly enhancing the detection of coronary artery calcification, Erez Meltzer, Nanox CEO told BioWorld.
Getinge AB agreed to acquire Paragonix Technologies Inc. for $477 million, including upfront and earn out payments. The deal marks Getinge’s entry into the global organ preservation and transportation market, a rapidly advancing field driven by rising transplant volumes, technological innovations and evolving clinical practices.
The U.S. FDA recently granted Medtronic plc approval for its deep brain stimulation (DBS) system to be used to treat Parkinson’s disease or essential tremor while a patient is asleep, under general anesthesia. The approval gives patients another option for DBS therapy which can transform their quality of life, Amaza Reitmeier, vice president and general manager for Medtronic brain modulation, told BioWorld in an interview.
Algodx AB received U.S. FDA 510(k) clearance for its sepsis detection software Navoy CDS. The technology, which analyzes patient data, has the potential to improve patient outcomes as it enables clinicians to detect and treat sepsis earlier.
