Brain MRIs can reveal a great deal about brain tumors, but tracking response to treatment, clearly delineating edges and identifying other critical information remain problematic. Neosoma Inc.’s recently granted FDA 510(k) clearance may simplify treatment of the most challenging of these tumors, high-grade gliomas. The Neosoma High-Grade Glioma (HGG) neuro-oncology software device uses artificial intelligence to provide detailed measurements and 3D analysis that enable greater precision in procedures and better monitoring.

Millions of patients with fibromyalgia have battled widespread pain with few effective treatment options for decades. The U.S. FDA has offered reason for hope and better health with four recent decisions. On Oct. 4, Solon, Ohio-based Multi Radiance Medical Inc. (MRM) received clearance for its Fibrolux therapy laser for the condition, following Neurometrix Inc.’s de novo authorization for its transcutaneous electrical nerve stimulation device, Quell, in May. Remedee Labs SA received breakthrough device designation (BDD) for its endorphin stimulation system in May and Swing Therapeutics Inc. was granted BDD for its digital therapy in Aug. 2021.

The American Academy of Ophthalmology (AAO) annual meeting in Chicago Sept. 30 to Oct. 3 covered the waterfront in the ophthalmic market, with positive signs for continued or improving health as supply kinks work out. Hurricane Ian’s impact on the other side of the country was also a topic, as Florida accounts for a disproportionate percentage of cataract surgeries, which may be delayed as a result of the destruction in the state. We provide some highlights from the conference, analysts’ meetings with company executives and some timely new developments in the sector.

The wholesale acquisition cost for Amylyx Pharmaceuticals Inc.'s new U.S. FDA-approved amyotrophic lateral sclerosis (ALS) treatment, Relyvrio, has been set at about $158,000 for the first year’s treatment. It jumps to about $163,000 in the second year, the company said, a change that would move it closer to the cost of competitor Mitsubishi Tanabe Pharma Corp.'s Radicava (edaravone), which costs about $165,000 annually. A 28-day prescription will cost $12,504.

The U.S. Congress passed a five-year reauthorization of the Medical Device User Fee Amendment (MDUFA) agreement, the fifth iteration of this user-fee agreement since the system's implementation in 2002, after many months of back and forth with the med-tech industry. The extension passed as part of a temporary spending bill needed to avoid a partial government shutdown ahead of Friday’s deadline. The spending bill passage gives lawmakers a reprieve until after the midterm elections when they'll need to figure out a longer-term funding plan for the fiscal year ending Sept. 30, 2023.

Stryker Corp. reported the launch of its Q Guidance system for spine applications. The system leverages new optical tracking options via a redesigned camera with the advanced algorithms of the newly released Spine Guidance software.

The individual and population-level health impact of type 2 diabetes is well documented, a fact which recently drove the U.S. Preventive Services Task Force (USPSTF) to ask whether screening among asymptomatic individuals aged younger than 18 years would be worth the effort. The answer is that the task force simply does not know, simply because the agency’s literature search turned up no studies that prospectively evaluated the benefits of screening in this population, signaling a missed opportunity for drug and device makers to intervene in this massively costly disease.

U.S. lawmakers concerned about unconfirmed clinical benefit of drugs with accelerated approval got more fodder for their arguments in a new report from the Department of Health and Human Services Office of Inspector General (OIG). According to that report, which was released Sept. 29, Medicare and Medicaid have spent more than $18 billion over the past few years covering 18 drugs granted accelerated approval that haven’t completed their confirmatory trials even though the trial completion dates have passed.