The FDA has granted de novo authorization to Neurolutions Inc. for its Ipsihand upper extremity rehabilitation system. The first-of-its kind device leverages robotics and brain-computer interface (BCI) technology to facilitate muscle training in patients with upper limb weakness or immobility following a stroke.

Depression treatment still isn’t “once and done,” but the time needed to reduce symptoms continues to drop for patients using electromagnetic stimulation. Brainsway Ltd.’s Theta Burst brings treatment times down to just three minutes with its FDA 510(k) clearance.

The FDA has approved Roche AG’s Ventana MMR Rxdx panel for patients with advanced or recurrent endometrial cancer. The companion diagnostic is the first to identify patients who are eligible for treatment with Glaxosmithkline plc’s (GSK’s) Jemperli (dostarlimab-gxly) monotherapy. The PD-1 antibody immunotherapy received FDA approval on Thursday.

TORONTO – Perimeter Medical Imaging Inc. has been awarded an FDA breakthrough device designation for a machine learning medical platform it said drives ultra-high-resolution, real-time imaging of breast cancer. Data collected from multiple pathology labs in Texas this past year were fed through the optical coherence tomography (OCT) imaging system which now is at the stage where its Imgassist artificial intelligence (AI)-based algorithms can be tested.

As of 2020, the NIH had identified 507 grant recipients who potentially had undisclosed conflicts of interest, with many of those conflicts involving affiliations with foreign governments that may expect the scientists to share or steal NIH-funded research.