Research
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National Cancer Institute, NIH
In first, FDA approves KRAS-blocking cancer drug from Amgen
After decades of scientists unsuccessfully targeting the KRAS gene, Lumakras is the first drug proven effective. The FDA Friday also approved companion diagnostics from Qiagen and Guardant Health.
By Ned Pagliarulo • UPDATED: May 29, 2021 at 12:35 p.m. -
Courtesy of Boston Scientific
Boston Scientific's Watchman shows low stroke rate in large registry at ACC
The fast-growing product performed well in an analysis of more than 36,000 people presented at the American College of Cardiology meeting, with low adverse event rates that surprised even the study's author.
By Susan Kelly • May 17, 2021 -
Sarah Silbiger via Getty Images
Paclitaxel, uncoated stents for PAD show similar mortality in real world study
The review of outcomes for Medicare beneficiaries contrasts a 2018 meta-analysis that identified a mortality signal for patients treated with drug-coated stents and balloons. Still, JAMA editors said mortality rates are troublingly high.
By Susan Kelly • May 17, 2021 -
Courtesy of Boston Scientific
TAVR readmission rates vary widely between hospitals for unknown reasons: study
Length of stay and discharge disposition only explained 15% of the inter-hospital variation. The study's authors have called for efforts to identify practices associated with low rates or readmission.
By Nick Paul Taylor • May 10, 2021 -
EU MDR delay has not made new rules easier to stomach: exec poll
Most of the 115 respondents to the Climedo Health survey said resources and lack of clarity were top challenges, with about a third indicating compliance efforts will cost their company 5% to 10% of annual revenue.
By Ricky Zipp • April 15, 2021 -
Adobe Stock
Fewer heart tests ordered for telehealth patients in pandemic
Research published in JAMA Network Open also found those using the virtual services were more likely to be Asian, Black or Hispanic.
By Susan Kelly • April 06, 2021 -
Medtechs top pharma in cash to doctors for consulting, travel: Health Affairs study
The majority of sector payments, also covering royalties, speaking fees and food, came from the likes of Medtronic, J&J, Zimmer, Stryker and Abbott. Specialties targeted included neurosurgery, orthopaedics and cardiology.
By Ricky Zipp • April 06, 2021 -
Alex Wong via Getty Images
Hospitals flailed amid COVID-19 crisis, are unsure of future, OIG says
Executives said they were worried about their workers experiencing trauma and concerned a shrinking recruitment pool for nurses could exacerbate staffing shortages.
By Ron Shinkman • March 25, 2021 -
AstraZeneca, Oxford vaccine prevents COVID-19 in big US study amid controversy overseas
A two-shot regimen was 79% effective at protecting people from COVID-19, which should support the fourth clearance of a vaccine in the U.S. and calm safety concerns abroad.
By Ben Fidler • March 22, 2021 -
Insulin pump adoption seen climbing 21% in 2021 on wearables boom: survey
The SVB Leerink poll of 101 endocrinologists and nurse practitioners also projects a shift in market position among top players like Medtronic, Insulet and Tandem Diabetes Care.
By Ricky Zipp • March 05, 2021 -
Moderna
FDA panel endorses Moderna's coronavirus vaccine
A group of independent experts supported use of the biotech's shot, which is likely to receive an emergency authorization from the agency within days.
By Ned Pagliarulo • UPDATED: Dec. 17, 2020 at 6:02 p.m. -
Getty Images
Docs paid by ICD makers more likely to favor manufacturer: JAMA study
Yale researchers found patients were more likely to receive certain cardiac devices from the company that made the largest payment to their doctor, though quality of care did not appear to be affected.
By Susan Kelly • Nov. 04, 2020 -
Adobe Stock
Duke researchers pitch CDS tool to keep electives going during COVID-19 surges
JAMA Network Open authors found that using predictive modeling to develop a clinical decision support tool could help determine patient length of stay and use of a ventilator in procedures like knee and hip replacements.
By Ron Shinkman • Nov. 02, 2020 -
Jacob Bell
Analysis of FDA safety alerts spurs call for changes to medical device adverse event reporting
Slow implementation of UDI and NEST are among the hangups prompting JAMA Internal Medicine authors to envision a better U.S. system for tracking and identifying adverse events, including more mandatory reporting.
By Nick Paul Taylor • Sept. 30, 2020 -
Courtesy of Abbott
Dexcom takes another step to keep CGMs in hospitals while Abbott targets athletes
By amassing early evidence in untapped populations, the companies hope to pursue lucrative new parts of the U.S. market.
By Maria Rachal • Sept. 18, 2020 -
Apple
Smartwatch EKGs could speed diagnosis of deadly heart syndrome, small study suggests
Some medical groups have questioned the use of wearables like the Apple Watch to detect certain conditions, but authors writing in JAMA Cardiology said they may be useful when an electrocardiogram is not available.
By Susan Kelly • Sept. 01, 2020 -
Getty Images
ER visits lag behind in hospital volume recovery
A survey of more than 500 U.S. hospitals shows ER visits were down 25% compared to pre-pandemic levels for the 3.5 months leading up to June 21.
By Shannon Muchmore • July 15, 2020 -
Fotolia
Q&AQ&A: New NESTcc chief on the real-world evidence group's 'pivot point' and COVID-19
Sandra Siami, the new head of the National Evaluation System for health Technology Coordinating Center, says the pandemic's limitations on traditional clinical studies have put alternative sources of device data in the limelight.
By Maria Rachal • June 29, 2020 -
NIH loops Quest into effort to test 10K Americans for antibodies against coronavirus
The agency did not disclose which antibody test it will use as part of the All of Us initiative, saying only that the assay has FDA emergency use authorization and is designed to detect IgG antibodies.
By Nick Paul Taylor • June 17, 2020 -
Key data on Medtronic's 780G, Insulet's Horizon kick off ADA 2020
Abbott, Dexcom and Tandem will also present results at the virtual American Diabetes Association meeting that runs through Tuesday.
By Maria Rachal • June 12, 2020 -
Cardiology group ranks best devices for aorto-iliac arterial interventions
The Society for Cardiovascular Angiography and Interventions detailed stances on several key issues, including endovascular device effectiveness, issued Thursday at its virtual conference.
By Nick Paul Taylor • May 15, 2020 -
Ventilator sharing among states critical to save COVID-19 patient lives: Health Affairs paper
Without a coordinated federal effort to promote the exchange of the breathing assist machines, thousands more Americans will die in the coming weeks as the virus continues its rampage across the U.S., a new paper warns.
By Susan Kelly • May 04, 2020 -
Getty Images
Study questions TAVR access disparities under new CMS coverage policy
The number of hospitals offering the less invasive aortic valve disease treatment could double under Medicare's revised coverage, but limited access in rural and safety net hospitals appears likely to persist, according to research.
By Susan Kelly • April 07, 2020 -
High-risk devices with expedited reviews more likely to be recalled, research suggests
As FDA's Breakthrough Devices Program rises in popularity, a JAMA Internal Medicine analysis found almost two-thirds of Class III devices approved with priority review status between 2005 and 2015 were recalled.
By Nick Paul Taylor • March 31, 2020 -
Joint FDA, industry real-world evidence center issues research frameworks
As real-world evidence gains momentum as a tool for assessing medical device safety and effectiveness, NESTcc is laying out guiding principles on research methods and ensuring data quality.
By Amritpal Sandhu-Longoria • Feb. 27, 2020
