Minnesota regulators are offering tax incentives in hopes of luring more large corporations to the North Star State, and at least one major medical device and diagnostics player is thinking of taking advantage of the offer.
The new 23 mm valve, the smallest in the CoreValve suite, allows Medtronic to provide the "broadest range of TAVI patient valve sizes," according to a press release.
By Stewart Eisenhart, Emergo Group
Processes in place to resolve scientific disagreements among FDA medical device reviewers need stronger definitions and clearer lines of responsibility, according to the US Health and Human Services Department.
Sen. Chuck Grassley (R-Iowa) launched an investigation into whistleblowers’ claims that the FDA systematically persecuted and spied on employees who voiced concerns over certain medical devices cleared for the U.S. market.
Animas Corp.’s OneTouch Ping
The FDA issued a warning letter to medical device giant Johnson & Johnson (NYSE:JNJ) saying that the company could face penalties including fines and injunction for failing to report incidents where its OneTouch Ping and 2020 insulin pumps may have caused death or serious injury.
The FDA issued a draft guidance today designed to increase the number of female subjects enrolled in med-tech clinical trials.
Certain medical devices could elicit different responses depending on gender, according to the federal watchdog agency. Basic differences such as genetics, hormones, body size, diet and socio-cultural issues may play a role in the efficacy of medical devices in patients, the FDA said.