Think Surgical said yesterday that it won 510(k) clearance from the FDA for its TSolution One robot-assisted total knee replacement device. The TSolution One system uses Fremont, Calif.-based Think Surgical’s 3D pre-surgical planning workstation and computer-assisted Active robot. It won CE Mark approval in the European Union for total knees in December 2017. “We are […]
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Fresenius settles Medicare over-billing case for $5m
Fresenius Medical Care (NYSE:FMS; ETR:FRE) agreed to pay more than $5 million to resolve allegations that its dialysis clinic business over-billed Medicare for hepatitis B tests. The country’s largest dialysis clinic operator, Fresenius Medical Care North America agreed to pay $5.2 million to settle federal prosecutors’ allegations that it billed Medicare for tests of dialysis patients […]
HHS proposes regulatory changes to promote value-based payment arrangements
UPDATED Oct. 9, 2019, with comments from press briefing in Minneapolis. The U.S. Department of Health and Human Services today proposed what it’s describing as a modernization of the physician self-referral law in order to promote value-based healthcare. The proposed regulatory changes, which are heading into a 75-day public comment period, say the physician self-referral […]
After 20 years at Boston Scientific, here’s what this medtech R&D leader has learned
David Knapp, VP of corporate research at Boston Scientific, has spent 20 years developing devices that cut across divisions at the medtech giant. At DeviceTalks Minnesota 2019, he gave attendees an insider’s view of what he’s learned about device development and healthcare. Want to see these interviews live? Join us at DeviceTalks West – Dec. […]
Mynosys Cellular Devices raises $25m for Zepto cataract device, names new CEO
Mynosys Cellular Devices said today that it raised $25 million for its Zepto cataract device and named ex-Tear Film Innovations chief Rob Thornhill to be its new CEO. Fremont, Calif.-based Mynosys said the new funding round, led by Decheng Capital, is earmarked for growing its U.S. commercial footprint, R&D, manufacturing and commercial organization. Decheng’s Dr. […]
Ex-Biomet worker in Brazilian bribery case loses appeal in defamation suit
A former Zimmer Biomet (NYSE:ZBH) employee can’t pursue defamation charges against the company related to his alleged involvement in a Brazilian bribery case, a federal appeals court ruled yesterday. In 2008 Biomet discovered that a distributor in Brazil, Sergio Galindo, had bribed healthcare providers to use its products. The company severed its relationship with Galindo and […]
iRadimed clears 5-year-old warning letter
iRadimed (NSDQ:IRMD) last week finally cleared a five-year-old warning letter from the FDA issued over quality issues with its IV infusion pumps. The August 2014 warning letter chided Winter Springs, Fla.-based Iradimed for its complaint handling and ordered it to seek a new 510(k) clearance for software upgrades to one of the pumps, the mRidium 3860+, […]
Study: Abbott, Edwards may have mislabeled hundreds of patient deaths
This report has been updated with comments from Edwards Lifesciences, Madris Tomes and the FDA. Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) may have mislabeled patient deaths as injuries or device malfunctions in hundreds of FDA adverse event reports involving their transcatheter aortic or mitral valve replacement devices, according to a new study. The study by JAMA […]
Staple snafu prompts voluntary Johnson & Johnson recall in Europe
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon initiated a voluntary recall of its Echelon Flex Endopath 60mm staplers across seven different European countries due to potentially malformed staples. The company identified the possibility that some Echelon Flex Endopath staplers may contain an out-of-specification anvil component within the jaw of the device. The issue could lead to malformed […]
Livongo jumps on federal employee benefits deal
Livongo Health (NSDQ:LVGO) shares jumped yesterday after the company landed a two-year deal with the Federal Employees Health Benefits Program that could add as much as $30 million a year to its top line. Mountain View, Calif.-based Livongo developed a digital health platform to manage chronic diseases, selecting diabetes as its first target. Yesterday the […]
Dexcom wins FDA clearance for G6 Pro CGM
Dexcom (NSDQ:DXCM) said today that it won 510(k) clearance from the FDA for its G6 Pro continuous glucose Monitor for diabetic patients ages ages two years and up. The San Diego-based company said the G6 Pro is designed to measure glucose data in real time over 10 days in either “blinded” or “unblinded mode,” depending on […]