FDA
publication date
Marketing
FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries
This week's alert is the second Class 1 recall of a HeartMate device this year.
Payer
New Report Targets Payer Pain Points for Digital Therapeutics Integration
The Digital Therapeutics Alliance is helping outline integrated digital product workflows that identify gaps for payers, clinicians, and patients.
Strategy
At Stake in Mifepristone Case: Abortion, FDA's Authority, and Return to 1873 Obscenity Law
A victory for the plaintiffs would lay the groundwork for a de facto nationwide abortion ban.
Technology
AI Coalition Pushes Forward With Governance Plans
The Coalition for Health AI (CHAI) is staking its claim as the industry?s best option for creating meaningful and acceptable...
Innovation
FDA Issues Alert on Smartwatches, Smart Rings for Diabetes Management
The agency is warning that no devices have been approved that can accurately measure a user?s blood glucose without piercing...
Technology
FDA Repeatedly Rejected Safety Claims Made by Philips After the CPAP Recall but Waited to Alert the Public, Emails Show
As Philips reassured patients that millions of recalled machines were safe, internal emails show federal regulators privately told the company...
Innovation
FDA's Robert Califf on AI in Healthcare: 'It's a Different World'
As health system execs attending CES 2024 talked of using AI to address specific challenges, the FDA commissioner pointed out...
Pharma
FDA issues first approval for mass drug imports to states from Canada
The agency authorized Florida to purchase medicines directly from wholesalers in Canada, where prices are far cheaper. Pharmaceutical companies oppose...
Pharma
Colorado Blames Biden Team and Drugmakers for Delaying Canadian Imports
The FDA has not determined whether the imports would save money for consumers without risking public health.
Innovation
Missouri Health System Improves Respiratory Disease Treatment With New Lung Scan
MU Health Care is one of only two health systems in the country to use the Xenon MRI, which could...
Covid-19
Is Novavax, the Latecomer Covid Vaccine, Worth the Wait?
Novavax's vaccine is based on proteins rather than mRNA and has been used since early 2022 in other countries.
Trump Misplaced Blame When He Said Drug Shortages Were Biden's Fault
"Under 'Crooked Joe' Biden, there has been a catastrophic increase in shortages of essential medicines." ? Donald Trump.