Sinaptica Therapeutics Inc. received a U.S. FDA breakthrough device designation for its electromagnetic therapy for Alzheimer’s disease. Sinaptistim-AD combines neurostimulation, brain wave monitoring and artificial intelligence (AI) to address the cognitive and functional decline in patients with the neurological disorder.
The White House laid out several timelines Oct. 18 as part of a national biodefense strategy for countering biological threats and enhancing global pandemic preparedness.
Aim Biotech Pte. Ltd. has launched a lab tool that can closely model human disease. The organic system can add vascularization and immune competence to organoids, spheroids and tumor biopsies. This allows for the creation of a more defined and tunable microenvironment that more closely emulates the complexity of human physiology.
Curvebeam AI Ltd. won a U.S. FDA breakthrough device designation for Ossview, its investigational software that detects osteopenia or reduced bone mass in the already fragile bones of women 70 years of age and older. Osteopenia is difficult to diagnose using conventional bone mineral density (BMD) testing because small changes in density mask major changes in bone microstructure.
The annual North American Spine Society (NASS) Conference wraps up in Chicago on Oct. 15 and management discussions and analysts make it clear that the sector is not yet back to normal. While September showed an uptick in procedures, spinal surgery continues to lag the recovery seen elsewhere in orthopedics. As the challenges of the past two years recede, two players have posted notable gains in market share and revenue—Globus Medical Inc. and Alphatec Holdings Inc.—perhaps indicating a competitive advantage for smaller, more agile companies.
Human brain organoids transplanted into rats could be used as an in vivo model for the study of neuropsychiatric diseases. Researchers at Stanford University managed to mature human organoid neurons in the somatosensory cortex of the animal's brain and incorporate them into its neural circuitry.The integration improved the morphological and physiological properties of the transplanted neurons. Compared to those of organoids in a Petri dish, human cells preserved their own identity, and they modified the rat's learned behavior through stimulation and reward experiments.
Two Medicare administrative contractors are examining a request for expanded Medicare coverage of continuous glucose monitors (CGMs) that would drop the requirement that patients routinely administer insulin at least three times a day. The requestors, Alameda, Calif.-based Abbott Diabetes Care Inc., and a group of stakeholders including the Juvenile Diabetes Research Foundation (JDRF), assert that such a change is not only endorsed by two medical societies, but is also supported by clinical evidence, and the net effect for industry may be to significantly accelerate sales of these devices.
Heartbeam Inc. has been awarded a patent for what it called “the first and only” 3D-vector, 12-lead ECG platform for heart attack detection, this in conjunction with a credit card-sized device inside a consumer’s wallet for personal monitoring. The company said it can record and remotely transmit a set of cardiac signals to a physician for review so that patients at high risk of cardiac arrest are not left alone deciding if an ER visit is warranted.
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.
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