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The FDA’s Center for Drug Evaluation and Research (CDER) has released a Manual of Policies and Procedures (MAPP) document that explains how the agency will classify complex new drug products and drug-device combination products assigned to CDER. Read More
The Department of Health and Human Services (HHS) has declared that the COVID-19 public health emergency (PHE) will continue for at least three more months, which means devicemakers will need to need to continue to adhere to the many guidances the FDA released that contain pandemic-specific directives. Read More
French diagnostics giant bioMérieux is acquiring San Jose, Calif.-based Specific Diagnostics, a company that has developed a rapid antimicrobial susceptibility test (AST) used to identify and quickly treat patients infected with antimicrobial-resistant pathogens. Read More
The FDA has released two final guidances outlining a new product review pathway for developers of facet-screw systems and denture-base resins. Read More
Abbott subsidiary St. Jude faces a new trial over patent claims by Niazi Licensing concerning a double catheter for the treatment of heart failure after an adverse ruling Monday by the U.S. Court of Appeals for the Federal Circuit. Read More
Magnolia Medical Technologies’ Steripath device reduced blood sample contamination rates by 81 percent hospitalwide in a study, according to researchers at a hospital in West Virginia. Read More
In the latest in a seemingly endless series of FDA warning letters directed at unapproved COVID-19 products, the agency cited a Michigan-based company about claims it has been making online for its nasal spray. Read More
Sensory Cloud of Boston, Mass., has received a warning letter from the FDA for promoting an unapproved saline spray device as a COVID-19 treatment. Read More
The FDA has released two final guidances outlining a new product review pathway for developers of orthopedic fracture fixation plates and surgical suture devices. Read More
When examining submissions for approval or clearance of device software, the FDA will carefully assess whether it has adequate cybersecurity, the agency said in a draft guidance released yesterday. Read More
Fort Worth, Tex.-based Sanara MedTech has high hopes for a promising wound imaging device and a companion biomarker assay it is gaining as part of its $5.1 million purchase of Precision Healing of Newton, Mass. Read More