Neurovalens Joins NSF at CES 2025 to Discuss Future of Sleep and Brain Health

Summary: Neurovalens, maker of the FDA-cleared Modius Sleep device for chronic insomnia, will join the National Sleep Foundation (NSF) at CES 2025 to participate in a panel discussion titled “SleepTech: A Gateway to Brain Health.” Kate Willis, Neurovalens’ vice president of commercialization, will discuss how sleep technologies like Modius Sleep can enhance sleep and cognitive…

Read More

FDA Proposes New Guidance to Improve Pulse Oximeter Accuracy Across Skin Tones

Summary: The FDA has issued new draft guidance aimed at improving the accuracy and performance of pulse oximeters across different skin tones. Current evidence shows disparities in how pulse oximeters perform for individuals with lighter and darker skin pigmentation. The proposed recommendations include standardized methods for evaluating skin tone, gathering clinical data, and updating labeling…

Read More

Never Too Busy to Pray

You can do more than pray after you have prayed, but you cannot do more than pray until you have prayed. —John Bunyan (The Golden Treasury of Puritan Quotations, 235) On a lonely hillside in the dim light before dawn, a man sits by himself, praying. He rehearses the Scriptures, sings lines from the Psalms,…

Read More

Merger Between NLS Pharmaceutics and Kadimastem Advances with SEC Filing

Summary: NLS Pharmaceutics and Kadimastem are progressing with their merger, having filed a registration statement with the US Securities and Exchange Commission (SEC). This merger aims to create a Nasdaq-traded biotechnology company. Kadimastem will become a wholly owned subsidiary of NLS, and after the transaction, Kadimastem shareholders will hold 85% of the newly merged company.…

Read More

Tonix Receives PDUFA Goal Date for Sleep-Enhancing Fibromyalgia Drug Candidate

Summary: Tonix Pharmaceuticals announced that the FDA has set a PDUFA goal date of Aug 15, 2025, for the decision on marketing approval for TNX-102 SL, a non-opioid treatment for fibromyalgia. This decision follows positive results from two phase 3 clinical trials, where TNX-102 SL demonstrated significant reductions in daily pain, along with improvements in…

Read More

Zepbound Approval for OSA a ‘Positive Development’ for Patients and Clinicians, AASM Says

Summary: The US FDA approved Zepbound (tirzepatide) on Dec 20, 2024, as a treatment for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. The American Academy of Sleep Medicine (AASM) responded positively to the approval but cautioned that Zepbound is only effective for obesity-related OSA and may not cure the condition. The AASM emphasized…

Read More

Awake to Jesus

Henry David Thoreau’s Walden might be one of the most lovely odes to a simpler, slower way of life. Thoreau, bone weary of city living, left everything and moved into the wilderness to enjoy solitude and work with his hands. He waxes eloquent about really attending to nature. After all, “a taste for the beautiful…

Read More