AXDX's Arc system gains FDA clearance, automating blood culture prep for faster microbial ID, improved sepsis outcomes and reduced hospital costs.
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CeQur has announced recently that the FDA has granted 510(k) clearance for its Simplicity system for an extended wear duration. Simplicity, a wearable, disposable bolus insulin delivery system, was developed as, essentially, a wearable insulin pen. Clearance extends the wear time for the wearable mealtime insulin delivery patch from three to four days. It marks […]
AXDX's Arc system gains FDA clearance, automating blood culture prep for faster microbial ID, improved sepsis outcomes and reduced hospital costs.
SENS' latest regulatory clearance is likely to simplify diabetes management with the help of a long-lasting CGM system.
CD(Suzhou) Biopharma, a rapidly advancing clinical─stage biotech company, has received clearance from the US Food and Drug Administration (FDA) for...
A novel technology for real-time monitoring of tool wear in precision machining has been developed, utilizing smartphone sensors. This advancement is...
Imugene has landed a prized FDA orphan drug approval for its bile tract cancer therapy following positive results from its recent metastatic advanced...
Imugene has landed a prized FDA orphan drug approval for its bile tract cancer therapy following positive results from its recent metastatic advanced...
GE Healthcare's MIM Software announces the receipt of FDA clearance for its Centiloid scaling tool to perform PET-based amyloid imaging.
The FDA approves AstraZeneca's Tagrisso for treating unresectable, stage III EGFR-mutated non-small cell lung cancer.
The FDA approves BMY's differentiated schizophrenia treatment for adults and broadens its diverse portfolio. Shares gain.
The United States federal government is suing some big pharmacy benefit managers over a system of drug rebates that regulators say has made the price...