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 ...

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

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 ...

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.

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 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 ...

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 ...

For the third time this year, the FDA has deemed an Abbott recall of its HeartMate 3 Left Ventricular Assist System (LVAS) as Class I, the most serious type of recall, following 81 reported incidents, ...

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