MASSDEVICE ON CALL —Medtronic’s (NYSE:MDT) controversial bone growth protein Infuse will get the Yale treatment as the university’s rock-star scientist Dr. Harlan Krumholz prepares to determine whether Infuse is safe and effective.
Riding on a wave of accusations against the company and researchers on its payroll, Medtronic paid Yale University $2.5 million to conduct an independent study of the Infuse orthobiologic protein, which is used in spinal surgeries.
The company hopes to clear up allegations that paid consultants who conducted research on Infuse covered up or under-reported the risks of the product, which may include excessive bone-growth, heightened cancer risk and male sterility.
"I think that for many people at Medtronic, these episodes are a great source of embarrassment," Krumholz told the Star Tribune. "I want to liberate the data, and let the science speak for itself."
Krumholz’s ultimate goal is to set a new standard for transparency in the way clinical studies paid for by companies are reported.
"We knew we had to take the high road and seek out a third party, a completely unbiased and independent organization," CEO Omar Ishrak told the paper."We want to take transparency of clinical data to a whole new level. What we’re doing is pretty unprecedented."
Medicare fraud investigators working with broken tools
Medicare investigators, who are paid tens of millions of dollars to catch cases of fraud, work with inaccurate and inconsistent data that makes tracking down cheaters extremely difficult, the Associated Press reported.
Number of hip lawsuits filed against DePuy break 2,500
There are about 2,600 hip implant lawsuits filed against Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics and about 20 new cases are filed daily, according to law firm Bernstein Liebhard LLP.
Massachusetts tops the list for e-prescribing
Massachusetts boasts the highest rate of doctors electronically prescribing medication to patients, the Boston Business Journal reported.
Ultra-thin brain implant monitors seizures, may one day treat them
Researchers developed an ultra-thin flexible electrode array that can be implanted in the brain to monitor activity during seizures and it may one day be able to help shut them down, according to a press release.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
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