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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clearance of device software, the FDA will carefully assess whether it has adequate cybersecurity, the agency said in a draft guidance released yesterday.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
MedTech Europe is adopting a revised ethics code that says collaborative research projects between devicemakers and nonindustry partners must “be for the benefit of patients or benefit the healthcare organization (HCO) and at least maintain patient care.” Read More
Durham, N.C.-based Bioventus is buying CartiHeal and its Agili-C implant for knee-joint cartilage surface lesions, a breakthrough device which recently received the FDA’s premarket approval. Read More
Information about leveraging validation data to support COVID-19 test approvals has now been added to the FDA’s COVID-19 Test Development and Review FAQ page. Read More