Category: On Call
Iowa Senator Chuck Grassley (R) isn't ready to let go of a years-old inquiry into the Myxo annuloplasty ring, accusing leadership at Northwestern University and Northwestern Memorial Hospital of withholding important documents.
MASSDEVICE ON CALL — Senator Chuck Grassley (R-Iowa) reanimated his inquiry into an Illinois university hospital and a surgeon-inventor who used his device there, following reports from an erstwhile whistleblower that claimed she was fired for providing evidence to federal investigators and for challenging the university's star surgeon.
Menssana Research's experimental 6-minute breath-test identifies women with early stage breast cancer or an abnormal mammogram, researchers report.
MASSDEVICE ON CALL — Diagnostics maker Menssana Research is making promising progress with a breath-test that the company says can identify at-risk breast cancer cases in just 6 minutes.
In a study of nearly 250 women at 3 centers in New Jersey, Washington and the Netherlands the test was able to accurately identify women with early stage breast cancer or with abnormal mammogram, Menssana said.
Medtech titan Medtronic is already the target of about 700 lawsuits over its controversial Infuse bone growth protein, and more complaints may be on the way.
MASSDEVICE ON CALL — Medtronic (NYSE:MDT) is mired in some 700 lawsuits over its Infuse bone growth protein, representing complaints from about 1,000 patients, the company revealed in recent regulatory filings.
Orthopedics giant Stryker becomes the official joint replacement company of the PGA Tour, landing premium space at events across the U.S. in 2014.
MASSDEVICE ON CALL — Medtech titan Stryker (NYSE:SYK) touted a new alliance with the PGA Tour, becoming the golf league's official joint replacement products partner.
Samsung's new Galaxy S5 smartphone features a heart rate sensor, and South Korean regulators are reviewing the technology to determine whether it qualifies as as medical device.
MASSDEVICE ON CALL — South Korean healthcare regulators are taking a closer look at Samsung's (LON:BC94) new Galaxy S5 smartphone in order to determine whether the built-in heart rate sensor turns the phone into a medical device.
U.S. healthcare regulators recover a record $4.3 billion in 2013 through initiatives for detecting and taking action against Medicare fraud.
MASSDEVICE ON CALL — Healthcare and Justice Dept. regulators hit a new record high in recovered healthcare dollars, with $4.3 billion returned to federal health programs in 2013.
That's a return of more than $8 for every $1 spent on federal Health Care Fraud and Abuse Control Programs, according to McClatchy DC.
New laws proposed by India healthcare regulators would for the 1st time treat medical devices as a category distinct from pharmaceuticals.
MASSDEVICE ON CALL — U.S. medical device makers lauded India's healthcare officials for progress on a bill that would for the 1st time separate medical device regulation from pharmaceuticals.
The bill was introduced last year and then referred to a standing committee. The committee's recommendations were tabled in December and are now under review by India's union health ministry, according to the Indo-Asian News Service.