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.
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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Atmo, Baird, Glympse, Medtronic, Sunbird, T2 Biosystems.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accuray, Motus GI Holdings, Nevro.
Rewalk Robotics Ltd. took strides to expand its portfolio—and achieve profitability—with an agreement to acquire Alterg Inc., a provider of anti-gravity systems for use in physical and neurological rehabilitation. Alterg uses NASA-derived differential air pressure (DAP) technology to reduce gravity’s effects on individuals with mobility challenges and pain. The $19 million deal is expected to close August 11, with additional cash earnouts tied to future revenue growth over the next two years.
The U.S. FDA’s final guidance for premarket submissions for device software functions serves as a much needed overwrite of a badly outdated policy but includes some significant changes over the legacy guidance. There are also a few changes between the 2021 draft and the 2023 final guidance, however, such as a call for more details about how software anomalies were discovered and what a root cause analysis would suggest about the origin of the anomaly.
Trinity Biotech plc. received U.S. FDA 510(k) clearance for its lab-based hemoglobin diagnostic system, the Premier Resolution system, which the company hopes will allow it to regain its market leading position in hemoglobin variant detection. The Premier Resolution system is an automated analyzer which quantifies fetal hemoglobin and hemoglobin A2 and detects more than 200 hemoglobin variants. The device is a modern successor to the company’s Ultra system which once held a leading position in the U.S. hemoglobin variant diagnostic market.
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