FDA approves wearable infusion device for advanced Parkinson disease
The U.S. Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only ...
USA Today3d
FDA recalls more than 2 million baked goods over concerns of listeria contamination
The Food and Drug Administration (FDA ... While the recall was initially issued on Jan. 7, it was upgraded to Class II on Wednesday. Class II is defined as “a situation in which use of, or ...
Business Wire22h
Reprieve Cardiovascular Builds Clinical Momentum with Positive Results from FASTR Pilot Trial and FDA Investigational Device Exemption Approval for Pivotal Trial
Reprieve Cardiovascular, Inc., a development-stage company focused on advancing acute decompensated heart failure (ADHF) ...
Modern Healthcare6d
Tariffs on medical devices will raise costs. Here's what to know
The 10% tariffs on Chinese goods began Tuesday. China reacted with a 15% tariff on coal and liquefied natural gas and a 10% tariff on crude oil, agricultural machinery, large-displacement automobiles ...
BetaKit6d
RetinaLogik ready to execute on vision with $1.1-million financing, Health Canada Class II approval
Calgary-based healthtech startup RetinaLogik has closed $1.1 million CAD in convertible note financing and secured a Class II medical device licence from Health ... has also registered with the US ...
pharmaphorum2d
FDA’s treatment of China-developed drugs spurs demands for multiregional clinical trials
Similar signs of growth can be seen in the amount of drugs, biologics and medical devices the country exports to the US. The US FDA notes that China ranks third among countries that export drugs ...
The FDA Issued a Class II Recall on More Than 2 Million Baked Goods — Including Dunkin' Products
More than 2 million baked goods have been recalled over fears that they're contaminated with listeria. On Wednesday, February ...
MedTech Dive6d
FDA labels recall of discontinued Olympus endoscope part as Class I
The update comes about six weeks after an early alert flagged reports of 120 injuries and one death linked to reprocessing of ...
National Law Review2d
FDA Issues Draft Guidance on Managing Cybersecurity Risks Affecting AI-Enabled Devices
On January 7, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance, titled “Artificial ...
Medscape6d
FDA Warns About Diabetes Device Smartphone Alert Settings
The US Food and Drug Administration (FDA) is cautioning patients and caregivers about the potential for not receiving blood ...
Fox News3d
FDA recalls more than 2 million cases of doughnuts
The Food and Drug Administration has classified a recall of 60 different doughnut products to its second-highest level, the agency announced earlier this week in an update to its website.
American Hospital Association4d
FDA warns of potential to miss notifications on smartphone-compatible diabetes devices
The Food and Drug Administration Feb. 5 released an alert notifying patients of a safety concern using diabetes devices such ...