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Countless hours of development, though those achievements represent only part of the journey. If you want your product to reach healthcare providers across the United States, every stage of development must also satisfy detailed FDA submission requirements through complete, accurate records that explain how the device performs.  The FDA approval process evaluates scientific evidence, testing, […]

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The FDA approved an updated round of COVD-19 vaccines for the 2026-2027 respiratory disease season that target circulating SARS-CoV-2 viruses.
The agency approved two messenger RNA-based vaccines manufactured by Moderna, according to the company:
Pfizer-BioNTech’s mRNA-based vaccine was approved for all adults aged 65 years or older, along with anyone aged 5 years through 64 years with a high-risk condition, the companies announced.
The FDA also approved Novavax and Sanofi’s updated Nuvaxovid shot — the only protein-based, non-mRNA COVID-19 vaccine available in the U.S. —

Newer IOL power calculations have good accuracy in eyes with intentional myopic targets, according to a study published in Journal of Refractive Surgery.
Francesco Biagini, MD, of San Martino Hospital, Genoa, Italy, and colleagues wrote that IOL calculations have improved to the point where patients expect better results.
“However, there are still patients who prefer to perform near activity without glasses and thus require a myopic target,” the authors wrote. “Only a few studies have investigated eyes with a target between 1.75 D and 3 D, and they are limited due to their small datasets,

Researchers identified quantifiable amounts of lead in popular tampon brands but determined such levels have “no demonstrated clinical consequence.”
A study in 2024 first measured metals in tampons and identified concentrations of 16 metal(loids), including toxic metals such as lead and arsenic.
An FDA study published in May in Toxicological Sciences confirmed traces of metals in tampons, but the amounts indicated “there is negligible toxicological concern,” the researchers concluded.
In the current analysis, conducted by healthcare company Oasishealth.app, Jacob Hands, MD, the company’s head of

The FDA has approved Bixlenvo, the first single-pill daily HIV therapy for adults being successfully treated on more complex regimens who are unable to take other available single-tablet HIV medications.
The accelerated approval was announced by Gilead Sciences, which developed the single-tablet regimen combining two of its existing drugs:
In an email, Gilead said the new combination “will be especially impactful for those aging with HIV” who rely on complex regimens that require multiple pills, offering them a more streamlined option.
The pill, which includes 75 mg of bictegravir and 50 mg of

MUNICH — In patients with left-sided infective endocarditis, a response-tailored antibiotic strategy conferred more time alive without antibiotic therapy compared with standard duration therapy, new data show.
For the POET II trial, presented at the European Society of Cardiology Congress and simultaneously published in The New England Journal of Medicine, the researchers randomly assigned 508 patients with left-sided infective endocarditis caused by Staphylococcus aureus, Enterococcus faecalis or streptococcus species who had undergone 2 to 4 weeks of antibiotic treatment to response-tailored

MUNICH — In patients with atrial fibrillation and intermediate risk for stroke, direct oral anticoagulants were linked to reduced risk for death, stroke and major bleeding compared with no anticoagulation, researchers reported.
The SINGLE-AF trial, conducted at 18 sites in South Korea, was presented at the European Society of Cardiology Congress and simultaneously published in The New England Journal of Medicine. Boyoung Joung, MD, professor of cardiology and director of the Yonsei Heart Rhythm Center at Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea, and

The United States’ death rate likely dropped to a record low last year, according to provisional CDC data.
The National Center for Health Statistics (NCHS) released the report, which offers an early estimation of the deaths that occurred in 2025, in late July.
Farida B. Ahmad, MPH, a health scientist and mortality surveillance lead at the NCHS, told Healio that the report “presents provisional 2025 U.S. mortality data on deaths rates” by leading causes and demographic characteristics.
“These data provide information on mortality patterns among U.S. residents by variables such as sex, age, race

MUNICH — In patients with symptomatic nonobstructive hypertrophic cardiomyopathy, aficamten led to greater improvements in health status and exercise capacity at 36 weeks compared with placebo, according to data from the ACACIA-HCM trial.
Aficamten (Myqorzo, Cytokinetics) is the first cardiac myosin inhibitor to show benefit in patients with nonobstructive HCM. In December 2025, the FDA approved aficamten to improve heart failure symptoms and exercise capacity in adults with symptomatic obstructive HCM. There are currently no proven treatment options for nonobstructive HCM beyond heart

MUNICH — In patients with transthyretin amyloidosis with cardiomyopathy, once-monthly eplontersen, in addition to current standard treatments, did not lower risk for death from CV causes and recurrent CV events compared with placebo.
Results of CARDIO-TTRansform, the largest trial in patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM) to date, were presented during a Hot Line session at the European Society of Cardiology Congress and simultaneously published in The New England Journal of Medicine.
“In the overall study population, eplontersen did not significantly reduce the