Globus Medical (NYSE:GMED) said today that it won 510(k) clearance from the FDA for its long-awaited Excelsius robot-assisted surgery platform, which is designed to integrate intra-operative CT and fluoroscopic imaging technologies. Audubon, Pa.-based Globus said the clearance covers minimally invasive and open orthopedic and neurosurgical surgeries, including screw placement in spinal and orthopedic procedures. The system won CE […]
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Endologix touts data from AFX, AFX 2 aortic stent graft trial
Endologix (NSDQ:ELGX) touted data today from its Leopard clinical trial, which compared Endologix’s AFX and AFX2 endografts to other commercially available bifurcated aortic endografts. The trial, which launched in 2015, has since enrolled 458 patients. The study’s primary endpoint is freedom from aneurysm-related complications, including aneurysm rupture, conversion to open repair and endoleaks. Freedom from ARC […]
Mylan inks $465m settlement with DOJ over EpiPen Medicaid classification
Mylan (NSDQ:MYL) said today that it inked a $465 million deal with U.S. Dept. of Justice to settle claims that it misclassified its EpiPen allergy auto-injector device with the Medicaid Drug Rebate Program. In October last year, The Centers for Medicare & Medicaid Services said that Mylan had been overcharging Medicaid for its EpiPen device for years, despite […]
Enteromedics closes $18m preferred stock offering
EnteroMedics (NSDQ:ETRM) said it closed its recent public preferred stock offering, raising a total of $18.1 million which is slated to support continued commercialization efforts, clinical and product development and general corporate purposes. In the offering, the company sold preferred stock units at $1,000 per unit, with each consisting of 1 share of Series B convertible […]
Novo Nordisk diabetes drug succeeds in late-stage trial
Shares in Novo Nordisk (NYSE:NVO) rose nearly 5% yesterday afternoon after the insulin-maker said that its once-weekly diabetes drug, semaglutide, succeeded in lowering glucose levels in a late-stage trial. The 40-week trial enrolled 1,200 patients and evaluated two dosages of semaglutide in combination with a standard-of-care-drug. The study compared its drug against Eli Lilly‘s (NYSE:LLY) dulaglutide compound. Get […]
UPDATE: Industry panels disintegrate in wake of Trump remarks
A pair of industry panels convened by President Donald Trump disintegrated today in the wake of his latest comments on the racist violence in Charlottesville. After Merck (NYSE:MRK) CEO Kenneth Frazier announced on Monday that he planned to leave Donald Trump’s manufacturing advisory panel, a wave of executives followed in his path. Today, reversing from a […]
ReCor Medical adds another $12m for trial of Paradise renal denervation device
ReCor Medical last week added a $12 million contribution from Otsuka Pharmaceutical (TYO:4578) to the $10 million it raised from the Japanese conglomerate last year for a clinical trial of its Paradise renal denervation device for treating hypertension, ReCor president & CEO Andrew Weiss told MassDevice.com this morning. In May 2016 Otsuka participated in a strategic investment of an unspecified amount; […]
Glytec lands another 510(k) clearance for diabetes management software
Glytec said today that it won a fourth 510(k) clearance from the FDA for its insulin titration software, eGlycemic Management System featuring Glucommander. The latest FDA nod applies to product enhancements derived from user feedback, the Waltham, Mass.-based company said, including a streamlined transition of inpatients from IV to subcutaneous therapy and more robust workflow capabilities. […]
Appeals court splits Stryker-DePuy poaching beef
A federal appeals court yesterday split up a sales rep poaching dispute between Stryker (NYSE:SYK) and Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics, sending some claims to a California district court and others to the federal court in New Jersey. Stryker’s Howmedica unit in June 2014 accused DePuy and a distributor of gutting its presence in the northern California […]
NuVasive taps new CFO | Personnel Moves – August 15, 2017
NuVasive Inc. (NSDQ:NUVA) said today that it tapped Rajesh Asarpota to be its new CFO effective Sept. 1, replacing Quentin Blackford, who jumped ship last month for the top finance spot at Dexcom Inc. (NSDQ:DXCM). San Diego-based NuVasive said Asarpota began his career at GE Healthcare (NYSE:GE)before moving to Life Technologies (NSDQ:LIFE), Questcor Pharmaceuticals and “private equity-backed healthcare […]
Aradigm lands NIH grant for inhaled, liposomal products
Aradigm Corp. (NSDQ:ARDM) said today that the National Institute of Allergy and Infectious Diseases and the NIH awarded the company a grant to study the treatment of pulmonary non-tuberculous mycobacteria infections with Aradigm’s inhaled liposomal ciprofloxacin products, Linhaliq and Lipoquin. The two-year grant is worth approximately $972,000, according to the Hayward, Calif.-based company. Get the full […]