The unique device identifier (UDI) might not be the most exciting U.S. FDA enforcement mandate for most of regulated industry, but the FDA’s Keisha Thomas indicated that compliance is less than adequate in the agency’s view. Read More
Neuronetics Inc. gained expanded approval in Japan for its transcranial magnetic stimulation (TMS) system to treat major depressive disorder called the Neurostar TMS, helping the Malvern, Pa.-based company increase its footprint in Asia. Read More
The COVID-19 pandemic took a huge bite out of the U.S. FDA’s ability to conduct inspections in a timely manner, but the FDA’s Douglas Stearn said the agency has nonetheless ramped up these activities. Read More
The U.S. FDA’s recent approval of Boston Scientific Corp.’s Tenacio pump, a component for its AMS 700 inflatable penile prosthesis (IPP), is an “exciting milestone” for the company, Ronald Morton, chief medical officer, Urology, at Boston Scientific told BioWorld. The AMS 700 IPP is a treatment option for men with erectile dysfunction and is designed to deliver a more intuitive experience for patients when using the device. Read More
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Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcam, Ambu, Arup Laboratories, Biomarin, Cardio Diagnostics, Danaher, Dexcom, Kaneka, Micro Medical Solutions, Otonexus Medical, Tandem Diabetes Care. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bearpac, Biospectal, MIM Software, Nsite. Read More
