Ambu A/S will pay $3.3 million to resolve allegations that it manufactured products in China and Malaysia for sale to U.S. government agencies in violation of the federal Trade Agreements Act (TAA), according to the U.S. Department of Justice. The government claims that the Danish medtech company submitted false claims to the Defense Logistics Agency […]
Dalent Medical readying to launch Sinusleeve device
Dalent Medical said last week that it has listed its Sinusleeve balloon sinus dilation device with the FDA. Sinusleeve is a single-use, disposable device used for treating chronic sinusitis, according to the Miami-based company. Sinusleeve is an FDA 510(k)-exempt Class 1 device that the company said it will begin marketing immediately to otolaryngologists in Florida. Get […]
Massive Teleflex endotracheal tube recall extends to Centurion Medical Products
A Class I recall of 6 million Teleflex (NYSE:TFX) Sheridan endotracheal tubes and connectors indicated for use on patients under general anesthesia has expanded to include connector kits manufactured by Centurion Medical Products, according to the FDA. Teleflex began recalling multiple models of its Hudson RCI Sheridan and Sheridan endotracheal tubes in June 2019 due to complaints of the Sheridan […]
GE Healthcare enters AI-powered aneurysm research effort
GE Healthcare (NYSE:GE) has joined a research collaboration with Fujitsu Australia and an Australian university and imaging clinic to diagnose and monitor brain aneurysms on scans faster and more efficiently using artificial intelligence (AI). The project with Macquarie University and Macquarie Medical Imaging today landed a $1.4 million grant from the Australian government. Fujitsu will […]
Organogenesis boosts outlook on higher Q2 sales
Organogenesis (NSDQ:ORGO) beat The Street on sales for the second quarter of 2019 and boosted its outlook for the rest of the year amid continued strong sales growth in its wound-care business. The Canton, Mass.–based regenerative medicine company reported a loss of $9.65 million, or -11¢ per share, on sales of $64.95 million for the […]
Endologix shares dip on Q2 loss of $27.1 million
Shares in Endologix (NSDQ:ELGX) slipped by 8% to $6.06 apiece in midday trading today following yesterday’s second-quarter results that beat The Street on earnings expectations and sales. The Irvine, Calif.-based company reported a net loss of $27.1 million or -$1.50 per share on sales of $36.24 million for the three months ended June 30, 2019, […]
Silk Road Medical ups its stock offering by $31.8 million
Silk Road Medical (NSDQ:SILK) increased a stock offering it registered earlier this week to $191.8 million, according to a regulatory filing. The company’s original registration for $159 million was to fund its transcarotid artery revascularization (TCAR) technology for the treatment of stroke. The Sunnyvale, Calif.-based company is now proposing an offering of 4.8 million shares of its […]
TransEnterix shares dive on disappointing Q2 sales
Shares of TransEnterix (NYSE:TRXC) started inching back up this morning following a nearly 33% plunge yesterday fueled by disappointing second-quarter results. The Research Triangle Park, N.C.-based company posted losses of $20.1 million, or -10¢ per share, on sales of $3.64 million for the three months ended June 30, 2019. Adjusted to exclude one-time items, losses […]
Cardinal Health beats The Street on Q2, FY 2019 earnings, expects $145 million restructuring charge
Cardinal Health (NYSE:CAH) beat Wall Street’s earnings consensus by 10% for the fourth quarter of 2019, despite a disappointing performance by its medical sector. The Dublin, Ohio-based company posted profits of $194 million or $0.65 per share on sales of $37.4 billion for the three months ended June 30, 2019, for a bottom-line gain of […]
Wright Medical stock dives on news of “knife fight” for sales reps, poor Cartiva sales
Shares in Wright Medical (NSDQ:WMGI) plunged 25% this morning on news of a “knife fight” with competitors over sales reps, and a $2 million lag in sales of its Cartiva arthritis treatment device. CEO Robert Palmisano told analysts late yesterday that smaller, privately owned competitors — which share the same independent distributor salesforce— are beating Wright […]
FDA wants more study of paclitaxel-eluting devices’ long-term safety
The FDA said yesterday that it wants more long-term safety and effectiveness studies done on paclitaxel-eluting stents and balloons, and urged physicians to carefully consider when to use them. In a letter to healthcare providers, the agency recommended discussing the risks and benefits of the devices with patients and continue “diligent monitoring” of patients who […]
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