Researchers find cold storage platelets safe and effective
Is smartphone screen time delaying your kid’s speech?
Experts warn smartphones are delaying kids’ language. The kicker? It’s not necessarily the children’s screen time that’s the problem.
The post Is smartphone screen time delaying your kid’s speech? appeared first on Medical News Bulletin.
FDA authorizes sale of 11 Zyn Ultra nicotine pouches
The FDA has authorized the marketing of 11 Zyn Ultra nicotine pouch products, which it states is an “important step to provide greater access to potentially less harmful alternative tobacco products for existing adult tobacco users.”
The agency made the decision after finding that the pouches “contain lower levels of most harmful and potentially harmful constituents” compared with other oral and smokeless tobacco products.
The Zyn Ultra products (Swedish Match USA, Inc.) included in this announcement are Chill 9 mg, Citrus 9 mg, Cool Mint 9 mg, Deep Freeze 9 mg, Menthol 9 mg, Peppermint 9 mg,
FDA clear PrecivityAD2, single blood test for Alzheimer’s
The FDA has cleared PrecivityAD2, a single blood test designed to help health care professionals rule in or rule out an Alzheimer’s disease diagnosis, according to a press release from the test’s developer, C2N.
PrecivityAD2 is the first Alzheimer’s blood test to be cleared by the FDA for symptomatic adults aged 40 years and older, according to the press release.
“We believe the PrecivityAD2 test will play a vital health system role in the years ahead to help streamline and simplify the complex diagnostic pathway that many patients face when dealing with serious memory concerns,” C2N CEO and
Fluticasone propionate nasal spray approved for allergy symptoms
The FDA has approved a fluticasone propionate nasal spray USP metered at 0.05 mg per spray from Glenmark Pharmaceuticals for allergy symptoms, according to a press release from the company.
Glenmark said its spray is bioequivalent and therapeutically equivalent to Flonase (Haleon). Indications include nasal congestion, runny nose, sneezing, itchy nose and itchy and watery eyes in adults and children aged 4 years and older.
“This will increase access to an already proven treatment option by ensuring timely supply across the market,” Marc Kikuchi, MBA, president and business head, North America,
Inebilizumab reduces exacerbations in gMG patients
Patients with generalized myasthenia gravis taking inebilizumab were less likely to experience exacerbations or need rescue therapy compared with a placebo group, according to research published in JAMA Neurology.
The implications are important for patients looking to avoid exacerbations, which often require hospitalization and are associated with significant morbidity, said Richard J. Nowak, MD, MS, director of the Myasthenia Gravis Clinic at Yale University.
“These are critically important insights and learnings from the phase 3 clinical trial, because not only are [myasthenia gravis]
FDA asks for feedback on AI regulation concept
The FDA is seeking feedback on a potential way of regulating medical devices equipped with generative AI features, informed by the process of training human clinicians.
Described as a “competency-based approach,” the process would evaluate AI-equipped devices in increasingly clinical scenarios, including potentially with real patients.
It is “inspired, at a high level, by how human clinicians are evaluated and credentialed,” according to an FDA discussion paper.
The paper also discussed ongoing evaluation of AI devices after they come to market, noting that the FDA is “considering whether it is
Woman presents with painful red eye, progressive vision loss
A 34-year-old woman presented with 2 weeks of a deep, dull ache behind her left eye accompanied by redness and light sensitivity. The pain was constant, worse with eye movement and not associated with any change in vision at onset.
She was evaluated by an ophthalmologist who noted scleral injection and started naproxen 500 mg twice daily. Her pain partially improved on this regimen; however, over the ensuing days, her vision became progressively blurry and cloudy in the left eye, prompting an urgent return approximately 2 weeks after symptom onset.
She denied significant discharge, double
Cataract surgery in highly hyperopic eyes
Performing cataract surgery in eyes with high degrees of hyperopia can give great refractive results, but there are challenges to overcome.
Eyes with short axial lengths typically have a shallow anterior chamber, a disproportionately large crystalline lens and elevated posterior vitreous pressure, all of which create a crowded space in which every surgical maneuver must be deliberate. Operating successfully in these short eyes requires a refined approach spanning preoperative evaluation, specialized biometry, modified fluidics and careful patient counseling regarding postoperative optics.
At