Accuray Inc. offered a classic good news-bad news set-up for investors on Wednesday, with a notable FDA clearance balanced by a miss on fourth quarter revenue and projections for fiscal year 2024 significantly below consensus expectations. Still, the takeaway is generally positive, with several strong catalysts expected to build momentum for the company in the coming year.

AI model predicts multiple sclerosis risk from patient data

A team from Siemens Medical Solutions Inc. has presented a new artificial intelligence (AI) model that can predict people’s risk of multiple sclerosis, at the 2023 American Association for Clinical Chemistry Annual Scientific (AACC) meeting in Anaheim, Calif. “Our model’s performance suggests that AI-based prediction models could identify the risk for multiple sclerosis years before neurological symptoms appear,” said Raj Gopalan, chief medical information officer at Siemens Medical Solutions Inc.

Theranica’s Nerivio to bring relief to migraine sufferers in Europe

Theranica Bio-Electronics Ltd. received expanded CE mark approval for Nerivio, a therapy that can both prevent and treat acute migraine in adults and adolescents. The Netanya, Israel-based company is now partnering with a large, publicly traded, pharmaceutical firm to launch the device later this year, first in Germany and then roll out commercial operations in several other European countries in 2024, Alon Ironi, CEO and co-founder of Theranica, told BioWorld. Earlier in the year, Theranica broadened its U.S FDA clearance for the Nerivio therapy which uses sub-painful remote electrical neuromodulation to activate nociceptive nerve fibers in the arm to send signals which trigger a descending pain management mechanism in the brain.

Biosense unveils Optrell mapping catheter to help treat persistent atrial fibrillation

Biosense Webster Inc. has launched a high-density diagnostic catheter designed to provide high-definition electrophysiological mapping of complex cardiac arrhythmias. The Optrell Mapping Catheter works in conjunction with Trueref technology powered by Carto 3 software to treat persistent atrial fibrillation representing the largest percentage of all arrhythmias.

US Federal Circuit says IPR petitioners must be able to respond to new claim construction

The inter partes review (IPR) process used to adjudicate patent disputes in the U.S. has had its share of critics, but ongoing patent litigation between Axonics Inc. and Medtronic plc. has disclosed another bone of contention in how these IPRs are handled. The Court of Appeals for the Federal Circuit has ruled that a patent holder, Medtronic in this instance, can offer a new claim construction for its disputed patent once an IPR has been instituted, but said also that the Patent Trial and Appeal Board (PTAB) had erred in not allowing Axonics to respond to the new claim construction, sending the related IPRs back to the PTAB for another look.

Also in the news:

Illumina, Capstan Medical, Shockwave Medical, Curonix, Rockley Photonics, Atmo Biosciences, Baird Medical, Sunbird Bio, T2 Biosystems, Accuray, Motus GI, Nevro.