The U.S. FDA granted Roche Holding AG breakthrough device designation for its Elecsys Neurofilament Light Chain test for multiple sclerosis. The Elecsys NfL test can aid in the detection of disease activity in adults, 18-55 years old, with relapsing-remitting multiple sclerosis or secondary progressive multiple sclerosis. It also provides critical information for managing the disease.
Recor Medical Inc. finally received U.S. FDA approval for its Paradise ultrasound renal denervation (RDN) system for the treatment of hypertension after more than ten years of research and clinical trials. Paradise is the first RDN system to reach the U.S. market, and its approval is good news for the technology after years of disappointment in the data from trials and concerns over the efficacy of RDN devices.
The acquisition of Icad Inc.’s brachytherapy business by Elekta AB takes the company a step closer to achieving its goal of providing hope to the millions of people dealing with cancer, John Lapré, president of Elekta’s Brachy and Neuro Solutions unit, told BioWorld. Elekta paid approximately $5.5 million for Icad’s subsidiary Xoft. In addition, most of Xoft’s staff and its main facility in San José, Calif., was transferred to the company.
Companies developing Artificial intelligence (AI)-enabled solutions have agreed to work with governments to test models both pre- and post-deployment, in a bid to manage the risks around security, safety and societal harms. The landmark agreement was reached at the first AI Safety Summit, held at Bletchley Park, in the U.K.
Quibim SL and Royal Philips NV have teamed up to utilize their artificial intelligence (AI)-enabled solutions to help clinicians deliver faster diagnosis and treatment of patients with prostate cancer. The partnership will see Philips AI-based magnetic resonance (MR) imaging technology integrated into Quibim’s AI based QP-Prostate software, to automate real-time prostate gland segmentation in MR images, and generate meaningful quantitative insights, as well as standardize MRI prostate exam reporting.
Immuone Ltd. raised £2 million (US$2.4 million) to fund expansion of its operations to meet growing demand for its 3D human lung model. The company is hoping that its model will replace animal testing which is not always accurate at predicting the impact of drugs on humans. The funding came from the MEIF Proof of Concept & Early Stage Fund, Mercia’s EIS funds and Pioneer Group.
As more and more artificial intelligence (AI)-based solutions get developed to improve patient care, humans should ultimately remain in control because no AI system will be free from mistakes, said Ha Hong, Chief Artificial Intelligence Officer in Medtronic plc’s Endoscopy unit. “There will be some errors, it is simply not possible to create a system that is 100% error free,” he told BioWorld in an interview.
United Therapeutics Corp. signed an agreement to acquire Miromatrix Medical Inc. for up to $140 million in cash, buying its way into additional organic growth. The deal would add Miromatrix’s comprehensive portfolio of bio-engineered organs to United’s existing organ production platform.
The U.K. government has launched a £100 million (US$122 million) fund that will accelerate the development of artificial intelligence (AI) tools to help tackle some of the biggest challenges in health care.
Hypnovr SAS recent takeover of Oncomfort SA will bring digital therapeutic solutions to a larger patient population suffering from pain and anxiety. Oncomfort has developed Digital Sedation, a non-pharmacological method of relieving patients’ pain and anxiety. This therapy, coupled with Hypnovr’s own virtual reality (VR) solution will help reduce medication use and improve the care pathway for patients undergoing medical procedures.
