Philips Respironics has recalled all Trilogy Evo ventilators that are not on the latest software update (1.05.06.00) due a software issue that can result in a sudden loss of ventilation while the ...

The company’s product line includes nebulizers, ventilators and related respiratory devices for hospital and in-home use.

Sandoz is withdrawing from the UK’s Prescription Medicines Code of Practice Authority (PMCPA) after being dinged for promotional wording of its biosimilar natalizumab in official documents presented ...

An updated version of the Biosecure Act gives US businesses until 2032 to decouple from four Chinese biotech companies identified as being of “particular concern” over data mining on behalf of the ...

The Department of Justice (DOJ) has formed a new enforcement arm — the Task Force Health Care Monopolies and Collusion (HCMC) — to guide the department’s policy approach for healthcare, but also to ...

Tandem Diabetes Care recalled its t:connect mobile app that is used with the t:slim X2 insulin pump with Control-IQ (continuous glucose monitoring) technology. The pump is intended to deliver insulin ...

The company had not established internal systems that result in timely and effective evaluation of events that may be subject to MDR requirements.

The FDA has joined forces with the Environmental Protection Agency (EPA) and the Department of Agriculture (USDA) on a plan to regulate genetically modified organisms and biotechnology products for ...

China-based Bioptimal International removed the heparin coating from the tubing for its thermodilution catheter without seeking FDA clearance for the device, earning the company a Warning Letter ...

The United Kingdom’s medicines and medical devices regulator has unveiled its approach to AI in a report presented to the UK government, urging transparency, inclusivity and aligning with partners ...

FDA advisory meetings, which since COVID have been tackled online, are returning to in-person status, said CDER Director Patricia Cavazzoni. Instead of meeting electronically, experts from across the ...

A major agency-wide reorganization affecting regulatory affairs and medical products, and more than $12 million to tackle supply chain issues across all products areas, were included in the FDA’s FY ...