Food and Drug Administration (FDA) News
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FDA Roundup: December 1, 2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - December 1, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Most Americans Are Quitting Smoking —Except For Those Over 65
An endless supply of trendy takes in recent years claim that among young adults, smoking is cool again. But though they may be hanging from the lips of major influencers and starlets, cigarettes have far more fans in an older demographic, according to new data on adult smoking behaviors in the United States. From 2011 to 2022, the prevalence of smoking habits decreased in every age bracket except one: the 65-and-up crowd.
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Public health campaigns and programs outlining the dangers of smoking aren’t really aimed at older adults, says Rafael Meza, an integrative onc...
Source: TIME: Health - December 1, 2023 Category: Consumer Health News Authors: Haley Weiss Tags: Uncategorized healthscienceclimate Source Type: news
Magnetica and Televere Systems join forces
Compact high-field MRI system developer Magnetica Limited has appointed Televere Systems as its official U.S. distributor for Magnetica’s product.Magnetica develops ultracompact superconducting magnets that will operate without the liquid helium. These cryogen-free superconducting magnets require significantly less infrastructure than traditional MR systems and can be used in nontraditional locations.Magnetic plans to seek U.S. Food and Drug Administration clearance by mid 2024. (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - December 1, 2023 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news
FDA Probes Quality Issues With China-Made Plastic Syringes FDA Probes Quality Issues With China-Made Plastic Syringes
The U.S. Food and Drug Administration said on Thursday it is looking into reports of leaks, breakages and other quality problems with plastic syringes manufactured in China.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 1, 2023 Category: Consumer Health News Tags: Hospital Medicine News Source Type: news
Canon highlights new CT scanners, workflow automation at RSNA 2023
CHICAGO - Canon Medical Systems unveiled two new CT scanners and a wide range of other offerings in its booth at RSNA 2023.CT Canon introduced two two new scanners, Aquilion One/Insight Edition and Aquilion Serve SP.The company's new flagship scanner, Aquilion One/Insight Edition is a premium system that pairs the company's Precise IQ Engine (PIQE) deep-learning reconstruction technology with Instinx -- translating into more efficient exams, according to Canon. It produces super-resolution 1024 matrix images for cardiac and body exams and features a 0.24-second rotation speed, which allows for one-beat scanning in patients...
Source: AuntMinnie.com Headlines - December 1, 2023 Category: Radiology Authors: Kate Madden Yee, Erik L. Ridley Tags: RSNA 2023 Source Type: news
No embecta-made syringes impacted by FDA safety communication
PARSIPPANY, N.J., Dec. 01, 2023 (GLOBE NEWSWIRE) -- Embecta Corp. ("embecta") EMBC, a global diabetes care company, today issued the following statement regarding the U.S. Food and Drug Administration (FDA) Safety Communication on evaluation of certain plastic syringes: "embecta, the world's…#parsippany #embectacorp #fda #holdrege #nebraska #shauncurtis #svp #linkedin #facebookinstagram #twitter (Source: Reuters: Health)
Source: Reuters: Health - December 1, 2023 Category: Consumer Health News Source Type: news
Bagel recall as FDA warns products could be " life-threatening " if consumed
A Michigan delicatessen has issued a recall of three subs and two types of breakfast bagels it produces as they "were distributed in packaging that did not reveal the presence of sesame," the Food and Drug Administration (FDA) said in an alert on Thursday. Gaws Gourmet Foods, based in Marysville,…#michigan #fda #gawsgourmetfoods #marysville #uscanada #detroit #gawhamcheddar #salamicheese #deluxeitalian #classicitalian (Source: Reuters: Health)
Source: Reuters: Health - December 1, 2023 Category: Consumer Health News Source Type: news
New CT, MR scanners and AI top GE HealthCare highlights at RSNA 2023
CHICAGO -- GE HealthCare (GEHC) brought new CT and MRI scanners and a range of AI software applications to McCormick Place for RSNA 2023. CT In CT, GEHC shined the spotlight on its Revolution Ascend scanner, which was first introduced at ECR in March. With onsite detector upgrades, Ascend can be upgraded from a 20-mm coverage system for routine scanning to a 40-mm coverage system that delivers better low-contrast detectability, according to the vendor. The scanner also comes with True Enhance DL, an AI-based application that generates deep learning-based monochromatic-like images from a single-energy x-ray acquisition....
Source: AuntMinnie.com Headlines - December 1, 2023 Category: Radiology Authors: Erik L. Ridley Tags: RSNA 2023 Source Type: news
TRUQAP (capivasertib), FDA Approved for the Treatment of Breast Cancer, Available at Biologics by McKesson
CARY, N.C., Dec. 1, 2023 —Biologics by McKesson, an independent specialty pharmacy specializing in oncology and rare diseases, was selected by AstraZeneca as a specialty pharmacy provider for TRUQAPTM (capivasertib). TRUQAP, which was approved by the U.S. Food and Drug Administration (FDA) on Nov. 17... (Source: McKesson News)
Source: McKesson News - December 1, 2023 Category: Information Technology Source Type: news
DBI issues statement of support for HR 3086 Find It Early Act
Dense Breast Info (DBI) has issued a statement of support for “Find It Early Act” HR 3086, a bill that addresses insurance barriers to breast cancer screening beyond an initial mammogram.If passed, HR 3086 would require insurers to cover additional ultrasound or MRI screenings with no out-of-pocket costs for women with dense breasts or at higher risk (for example, BRCA or other disease-causing mutation carriers, those with family/personal history of cancer, or other reason), according to DBI.Beginning September 2024, the U.S. Food and Drug Administration (FDA) will require that women be informed after their mammograms ...
Source: AuntMinnie.com Headlines - December 1, 2023 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Subspecialties Breast Imaging Source Type: news
A certain kind of cancer treatment may cause new cancer in some patients, FDA warns
According to the Food and Drug Administration, a life-saving type of cancer treatment may sometimes cause cancer. On Tuesday, the FDA said it received 19 reports of new blood cancers in patients who got chimeric antigen receptor, or CAR, T-cell immunotherapies. CAR-T therapy was first approved in…#fda #healthcare #mediagroup #cnnnewsource (Source: Reuters: Health)
Source: Reuters: Health - December 1, 2023 Category: Consumer Health News Source Type: news
Vivos receives FDA 510(k) clearance for oral devices to treat severe sleep apnea
None Vivos Therapeutics has received 510(k) clearance for the use of its oral devices in adults with severe obstructive sleep apnea (OSA). • None The Food and Drug Administration ruling, which comes 11 months after Vivos received clearance for an oral appliance in mild-to-moderate OSA, gives the…#nonevivos #osa #vivos #fda #philips #kirkhuntsman #medicare #medtechdive (Source: Reuters: Health)
Source: Reuters: Health - November 30, 2023 Category: Consumer Health News Source Type: news
Why ‘ Healthspan ’ May Be More Important Than Lifespan
In 2014, then-57-year-old bioethicist Dr. Ezekiel Emanuel wrote an infamous essay titled, “Why I Hope to Die at 75” for The Atlantic. His argument boiled down to this: it’s not worth living as long as humanly possible if those efforts yield extra decades defined by disease and poor health, which data suggest is the fate awaiting many people in the U.S.
Nearly a decade later, neither Emanuel’s mind nor the statistics have changed much. Emanuel still says he plans to stop most life-extending medical care once he reaches age 75, though he’s healthy enough that he expects to live longer natural...
Source: TIME: Health - November 30, 2023 Category: Consumer Health News Authors: Jamie Ducharme Tags: Uncategorized healthscienceclimate Source Type: news
The Petri Dish: Flagship opens U.K. hub, FDA warns of complications from CAR-Ts
Biotech companies are on alert after the U.S. Food and Drug Administration unexpectedly said that certain types of CAR-T drugs could occasionally cause cancer. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - November 30, 2023 Category: Pharmaceuticals Authors: Rowan Walrath Source Type: news