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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clearance of device software, the FDA will carefully assess whether it has adequate cybersecurity, the agency said in a draft guidance released yesterday.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
Several advocacy groups have written to the House Energy and Commerce Committee and its Subcommittee on Health to defend the “right to repair” devices and push back against what they view as moves to restrict it. Read More
German device manufacturer Fresenius Kabi is acquiring Massachusetts-based infusion system manufacturer Ivenix in a purchase deal that includes $240 million upfront and future milestone payments. Read More
DermaSensor’s optical spectroscopy device has demonstrated a 96 percent melanoma detection rate and a negative predictive value of 98.1 percent in a clinical trial, the company said. Read More