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.
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,
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
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,
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]
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
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
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
A one-stage approach to treat patients with periprosthetic joint infections after primary total knee and hip arthroplasty offers noninferior outcomes to two-stage treatment, according to recently published results.
“The caveat here is that you have to follow a very specific protocol,” Thomas Fehring, MD, a hip and knee surgeon at OrthoCarolina Hip and Knee Center, told Healio. “You must do a meticulous debridement when taking out the implants. You then have to take all the dirty instruments out of the room, bring in clean instruments, then re-prep and re-drape. Hence, this is a fairly
Of more than 1,300 AI medical devices cleared by the FDA, only three tested for patient-centered outcomes like death and morbidity, data show.
AI integration into healthcare is rapidly progressing. Medical societies like the AMA have called for stricter regulations due to concerns about bias and transparency in clinics and health insurance decision-making.
According to Rawan Abulibdeh, a postdoctoral fellow at University Health Network in Canada, and colleagues, the FDA has cleared at least 1,357 AI medical devices.
“Clinical decisions increasingly depend on algorithmic outputs,” they wrote in