Latest From Elizabeth Orr
Can a false-claims suit be filed if doctors have different opinions about whether a treatment was necessary? The Supreme Court won’t say.
The proposed class action suit alleges that W.B. Mason took advantage of the pandemic by overcharging for the phony respirators.
The company ordered the recall after three stent fractures and a death occurred in an 89-participant clinical trial.
The US agency’s safety alert says the devices, which measure blood oxygen levels, may be less accurate in patients with darker skin tones.
The program will be open to roughly a hundred device firms with traditional 510(k)s under review between March and May of this year.
Shifting trial design and missing data, plus little evidence of benefit, worked against the paclitaxel-coated balloon, panelists and US FDA speakers said.