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The FDA issued a final guidance explaining its current policy on when agency staff may refuse to consider device companies’ applications for 510(k) clearance of a new product. Read More
The multiplex test will help address increasing rates of sexually transmitted infections (STIs), after disruptions in care during the pandemic contributed to a decline in routine STI screening, the company said. Read More
SpineX previously received a Breakthrough Device designation for treatment of neurogenic bladder, an incurable condition in which the relationship between the nervous system and bladder function is disrupted by injury or disease. Read More
The FDA has handed Microbiologics a Form 483 for not reporting device recalls and not properly documenting process controls, following an inspection of the company’s facility in Saint Cloud, Minn., in November and December. Read More
A consumer of lidocaine patches sold by Target has filed a class-action lawsuit against the retailer, claiming that the devices don’t stick to the skin and aren’t strong enough. Read More
Developers of devices that are intended to improve glycemic control in patients with type 2 diabetes should conduct an early-stage feasibility and safety study to support additional trials that further hone in on feasibility, the FDA said in a final guidance. Read More