Baltimore-based Coaptech LLC won a green light from the U.S. FDA for its PUMA-G system, which enables ultrasound-based placement of percutaneous gastrostomy feeding tubes. The PUMA-G system is the first application of the company's Point-of-care Ultrasound Magnet Aligned (PUMA) system platform, which enables ultrasound to work in hollow organs of the body for diagnostic or interventional procedures. Read More
The U.S. Federal Trade Commission (FTC) has been active for some time in enforcement of its regulations for direct-to-consumer (DTC) gene testing firms, but Linda Malek, a partner at the New York office of Moses & Singer LLP, told BioWorld MedTech that while FTC compliance is becoming a bigger lift for DTC gene testing firms, the controversy in 2018 over a gene testing firm's sharing of data with a drug maker suggests that DTC gene testing companies might want to "hold yourself to an even higher standard in order to maintain trust in your product." Read More
