Regulatory & Quality

While some believe cutting ties with China would serve as an impetus for more goods to be made in America, some medtech leaders think it could be disastrous — especially during a pandemic.

Join News Editor Amanda Pedersen on Tuesday via Facebook Live for a candid discussion about the ongoing trade war between the United States and China, and how it impacts the global medical device supply chain. The Medtech Unfiltered live stream...

FDA provided a list of medical device shortages during the ongoing COVID-19 pandemic.

The Erlangen, Germany-based company has won the designation for semi-quantitative Sars-CoV-2 IgG antibody tests. The tests estimate the quantity of a patient’s antibodies produced against infection with the virus that causes COVID-19.

FDA has revoked a previously-issued emergency use authorization for another COVID-19 antibody test.

Separate risk management and FMEA for better medical device development.

Medical device experts advise focusing on quality at every stage.

FDA approved Medtronic's rechargeable device to deliver sacral neuromodulation therapy for the treatment of overactive bladder, fecal incontinence, and non-obstructive urinary retention.

The Medical Device Innovation Consortium is seeking manufacturers to participate in a new pilot study intended to help manufacturers who have had trouble achieving and sustaining quality compliance.

The Peachtree Corners, GA-based company said it submitted its protocol to FDA for a clinical study to support the marketing of the LuViva Advanced Cervical Scan.