Brainsgate Ltd. came up short in a recent FDA advisory hearing for the company’s Ischemic Stroke System (ISS) to treat stroke despite that the panel was unanimously satisfied with the pivotal trial’s safety numbers. One of the issues with the pivotal study was the small enrollment of study subjects in the U.S., which demonstrates once again the hazards of relying on outside-U.S. study data in applications with the FDA.

The controversial approval of Biogen Inc.’s Aduhelm (aducanumab) in June sharply increased the interest in developing a quick, painless method of diagnosing Alzheimer’s disease (AD). Now, more than half a dozen blood-based diagnostic assays are in development and one is commercially available, albeit without FDA clearance.

Far from the Groundhog Day spectacle of amyloid-targeting antibodies that do little to nothing for patients in trial after trial, researchers have reported success in reducing the risk of Alzheimer’s disease (AD) in unexpected ways. Researchers at the Cleveland Clinic Foundation have discovered that a Viagra prescription was associated with a roughly 70% reduced risk of being diagnosed with AD. And investigators from the University of Washington reported that in the prospective Adult Changes in Thought study, a long-term study into risk and protective factors for dementia, persons who underwent cataract surgery reduced their risk of AD by 30%, an effect that lasted for 10 years after surgery.

Nextsense Inc. reported partnerships with global biopharma company UCB SA, Heraus Holding GmbH, the University of California San Diego and Emory University at its first public appearance at the American Epilepsy Society Annual Meeting in Chicago this past weekend. The Nextsense platform uses biosensing earbuds to perform ongoing electroencephalograms (EEGs).

Wave Neuroscience Inc.’s study of the use of electromagnetic stimulation to treat post-traumatic stress disorder (PTSD) entered its second phase, building on the positive outcomes seen in the phase I collaboration with the U.S. military. Texas A&M University Health Science Center is directing the trial, which will expand the study to civilians.

The FDA granted 510(k) clearance to Metame Health Inc.’s Regulora, the company’s prescription digital therapeutic (PDT) for abdominal pain associated with irritable bowel syndrome (IBS). Regulora provides gut-directed hypnotherapy in a smartphone app that is designed to help patients better manage their symptoms and address miscommunication between the brain and gut that contributes to sensations of pain.

The FDA cleared Hyperfine Research Inc.’s advanced image reconstruction technology using deep learning for its portable magnetic resonance imaging device, Swoop. The bedside MRI unit’s artificial intelligence application received clearance in January and is used with deep learning to improve image quality and diagnostic value. Hyperfine and Liminal Sciences Inc., which share a founder in serial entrepreneur Jonathan Rothberg, are both combining with special purpose acquisition company Healthcor Catalio Acquisition Corp. to go public in a deal valued at $580 million. The companies reported on Nov. 29 that the Securities and Exchange Commission declared the registration statement on form S-4 for the combination to be effective and the SPAC’s shareholders will vote on the transaction on Dec. 21.

Ieso Digital Health Ltd. raised £39 million (US$52.5 million) in financing to develop new tools for its digital cognitive behavioral therapy (CBT) service. Investment firm Morningside led the series B round with Sony Innovation Fund and existing shareholders IP Group, Molten Ventures and Ananda Impact Ventures also participating. Ieso’s digital platform connects users to mental health practitioners for text-based therapy.

PARIS – Pcube-Lab BV has closed a $4.75 million funding round to deploy its eye tracking technology, Neuroclues, in Europe and the U.S. This technique helps with early diagnosis of neurological disorders such as Parkinson's, multiple sclerosis and Alzheimer's disease.

The FDA gave Pear Therapeutics Inc. a second breakthrough device designation with the company’s Reset-A prescription digital therapeutic (PDT) for alcohol use disorder getting the regulatory agency’s speed pass. The news comes a week out from the vote of stockholders of blank-check company Thimble Point Acquisition Corp. Inc. on a combination with Pear that will take the digital therapeutic company public.