Accuray Inc. offered a classic good news-bad news set-up for investors on Wednesday, with a notable FDA 510(k) 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 and much of the underperformance attributable to foreign exchange headwinds that have plagued many med-tech companies. Read More
A team from Siemens Medical Solutions Inc. presented a new artificial intelligence (AI) model that can predict people’s risk of multiple sclerosis (MS), at the 2023 American Association for Clinical Chemistry (AACC) annual scientific meeting in Anaheim, Calif. Read More
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. Read More
It's one thing to ablate a lesion to treat a cardiac arrhythmia “but you can’t ablate the right place if you don’t know where it is,” said Nikki Sidi, U.S. President ofBiosense Webster Inc. Sidi was commenting on the July 24 U.S. launch of the high-density diagnostic Optrell mapping catheter with Trueref technology powered by its Carto 3 software. Read More
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 revolving around nerve stimulation technology between Axonics Inc., and Medtronic plc has disclosed another bone of contention in how IPRs are handled. The Court of Appeals for the Federal Circuit has ruled that a patent holder, Dublin-based 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. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Atmo, Baird, Glympse, Medtronic, Sunbird, T2 Biosystems. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accuray, Motus GI Holdings, Nevro. Read More
