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What the New CMS Payment Proposals Mean for Device Makers

Dive Brief The Centers for Medicare and Medicaid Services shared a pair of proposed rules on Thursday afternoon that set rates for physician payments and outpatient procedures. The agency issued the 2024 Hospital Outpatient Prospective Payment System and 2024 Physician Fee Schedule proposed rules, both of which are expected to be finalized this fall. Glaukos could be the biggest beneficiary of the proposals among device makers, with an increase in outpatient facility fee rates likely to provide a “meaningful boost” for its iStent device to treat patients with glaucoma, BTIG analyst Ryan Zimmerman wrote in a research note on Thursday. Dive Insight The two payment proposals include reimbursement increases for some medical device companies, and cuts for others. San Clemente, Calif.-based ophthalmic device company Glaukos is among those who stand to benefit. Its ambulatory surgical center facility fee for the iStent infinite device was nearly doubled ...
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- July 17, 2023
A Rare but Important Cause of Chronic Sinusitis

A new research perspective was published in Oncoscience (Volume 10) on May 27, 2023, entitled, “Think outside the box – atypical infections in chronic sinusitis.” Inflammations of the paranasal sinuses represent a common clinical picture. The annual prevalence of chronic sinusitis in Europe is up to 10%. Sinusitis can be divided into acute and chronic forms. In particular, the chronic forms (>12 weeks duration) are often challenging in the context of therapy. Generally, all ventilation disorders of the paranasal sinuses (concha bullosa, nasal septal deviations, etc.,) represent risk factors for the development of any form of sinusitis. In addition, an immune deficiency or systemic diseases relevant to the immune system predispose to infections with atypical pathogens. Most sinusitis are caused by viruses, sometimes bacteria and, in rare cases, fungal infections. Furthermore, sinusitis can be differentiated with regard to the affected paranasal sinuses. In addition to conservative ...
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- 132
- July 17, 2023
NHS Extends Eligibility for Shingles Vaccine to Almost One Million People

The NHS has announced that almost a million more people (900,000) will become eligible for a shingles vaccination with the newly available vaccine, Shingrix, starting in September. The decision was made after the Joint Committee on Vaccination and Immunisation (JCVI) recommended that the Shingrix vaccine be given to a wider cohort of people after trials showed that the vaccine was highly effective and safe for people in those groups. Shingles is an infection that can occur at any age. It causes a rash that can be extremely painful and the pain can remain for many years after the rash has disappeared. Although it cannot be transmitted from other people, it develops in people who have previously been infected with chickenpox over their lifetime. Studies have shown that nine out of ten adults are already infected with the virus that causes shingles, and around one in four ...
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- 212
- July 15, 2023
FDA Greenlights First Over-the-Counter Birth Control Pill

Women of all ages in America will soon have access to a birth control pill that does not require a prescription, after the US Food and Drug Administration (FDA) approved Perrigo’s Opill (norgestrel). The progestin-only pill will be the first contraceptive medication in the US that can be bought from the same aisle as paracetamol or toothpaste. Marketed as Opill, Perrigo gained control of the drug after an acquisition of HRA Pharma in 2022. In a statement, the FDA said that the non-prescription availability of the medicine will help reduce barriers to accessing contraceptives. The once-a-day pill should be available early next year, but its pricing remains to be announced. The approval comes amidst a widening cultural divide regarding women’s health rights. Many US states have introduced laws that ban abortion after the US Supreme Court overturned Roe v Wade. Opill’s availability opens accessibility avenues to women’s ...
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- July 15, 2023
Prevalence of atopic diseases increased in sexually diverse individuals

The prevalence of atopic diseases, including atopic dermatitis, is increased in sexually diverse people, including those who identify as lesbian, gay, or bisexual, according to a research letter published online July 12 in JAMA Dermatology. Katelyn J. Rypka, from the University of Minnesota Medical School in Minneapolis, and colleagues calculated crude and multivariable-adjusted odd ratios for prevalence of atopic dermatitis, asthma, and allergic rhinitis comparing heterosexual and sexually diverse individuals. Data were included for 27,012 respondents to the 2021 National Health Interview Survey, of whom 25,701 were heterosexual and 1,311 were sexually diverse. The researchers found that sexually diverse individuals were more likely to report atopic dermatitis (11.1 versus 7.2 percent), asthma (12.0 versus 7.8 percent), and allergic rhinitis (33.7 versus 25.6 percent) compared with heterosexual individuals (adjusted odds ratios, 1.49, 1.39, and 1.30, respectively). In sex-stratified analyses, results were similar. “This study found higher rates of atopic disease among sexually diverse ...
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- July 15, 2023
Food insecurity tied to slightly faster memory decline

Food insecurity is associated with slightly faster memory decline in middle- to older-aged U.S. adults, according to a study published online July 3 in JAMA Network Open. Peiyi Lu, Ph.D., from Columbia University in New York City, and colleagues examined whether exposure to food insecurity is associated with changes in memory function among 12,609 middle- to older-aged U.S. adults (11,951 food-secure and 658 food-insecure) followed for 18 years (1998 to 2016). The researchers found that over time, the memory function of the food-secure respondents decreased by 0.045 standard deviation units annually (β for time, −0.045), with a faster memory decline rate among food-insecure respondents than food-secure respondents. However, the magnitude of the coefficient was small (β for food insecurity × time, −0.0030), yielding an estimated 0.67 additional (i.e., excess) years of memory aging over a 10-year period for food-insecure respondents compared with food-secure respondents. “The study noted a longitudinal association between food insecurity and memory ...
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- July 15, 2023
Roche’s New Subcutaneous Version Measures up to IV Ocrevus in Multiple Sclerosis

With the multiple sclerosis market growing rapidly—from $18.9 billion in 2020 to a projected $29.8 billion in 2030, according to GlobalData—Roche is primed to take advantage with Ocrevus (ocrelizumab).Now the monoclonal antibody, which racked (PDF) up nearly $7 billion in sales last year, appears on the verge of gaining an added advantage with a more convenient way to be administered. A phase 3 study has shown that a new, subcutaneous version of Ocrevus has proven to be non-inferior to the current infused treatment as measured by the level of drug in the blood, 12 weeks after administration. Specific numbers were not included in Roche’s release but the company said that the trial achieved both its primary and secondary endpoints. The injected version also matched the performance of the infused treatment in controlling magnetic resonance imaging (MRI) lesion activity in the brain over 12 weeks, Roche said. The injected regimen of Ocrevus is a ...
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- 167
- July 15, 2023
2023 Mid-Year Review

BTIG analysts share insights gleaned from tracking medical device clearances, approvals, and FDA review times. COVID-related backlog at FDA had a real impact on medtech approvals there for a while. Now that the pandemic is officially over, are things back to normal for medical device approvals? Medtech analysts at BTIG recently shared some mid-year insights based on multiple years of tracking FDA approval databases. The bottom line: 510(k) clearances are down a bit, PMA approvals are on track to grow substantially, and review times have been mixed depending on the pathway. Through June, there were 1,586 510(k) clearances. At this pace, there would be about 3,075 FDA clearances at the end of the year, representing a 4.4% dip compared to the number of clearances in 2022. The analysts at BTIG noted that it is taking an average of 162.8 days for the agency to render a decision regarding a 510(k) ...
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- July 15, 2023
Urotronic Wins FDA Approval to challenge Boston Scientific, Teleflex for Prostate Market

Dive Brief The U.S. Food and Drug Administration has approved Urotronic’s minimally invasive surgical treatment of symptoms linked to benign prostatic hyperplasia (BPH), the company announced Tuesday. BPH is defined by the expansion of the prostate. As the organ grows, it can cause changes in the bladder that result in lower urinary tract symptoms such as leaking urine. Urotronic’s newly approved Optilume BPH catheter system is designed to tackle the symptoms through mechanical dilation and the delivery of paclitaxel to stop the problem from recurring. Dive Insight Researchers studied the use of balloon dilation in BPH in the 1990s, but the technique failed to provide long-term benefits. Urotronic has tried to address that problem by pairing the immediate symptomatic relief provided by balloon dilation with localized delivery of paclitaxel, a drug that is already widely used in cardiovascular devices to prevent blood vessels from narrowing after ...
- Source: drugdu
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- July 15, 2023
Macrophages May Play a Major Role in the Development of Atrial Fibrillation

Current treatments for atrial fibrillation (AFib), a common heart condition characterized by fast and irregular beats that can lead to stroke and heart failure, have multiple side effects and are ineffective for preventing AFib recurrence. New research led by investigators at Massachusetts General Hospital (MGH) and published in Science reveals that certain immune cells play a major role in the development of AFib. Targeting these cells may therefore represent a promising strategy to treat and prevent AFib. For the work, senior author Matthias Nahrendorf, MD, PhD, an investigator in MGH’s Center for Systems Biology and the Richard Moerschner Endowed MGH Research Institute Chair in Men’s Health, and colleagues analyzed single cells from atrial heart tissue collected from patients with and without AFib. The analyses indicated that immune cells called macrophages are the most dynamic cell population in the atria during AFib, and these cells expand more than any ...
- Source: drugdu
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- July 15, 2023

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