Medtech developer Concept Medical said today it won FDA breakthrough device designation for below-the-knee (BTK) use of its MagicTouch sirolimus drug-coated balloon catheter designed for the treatment of peripheral artery disease. The Tampa, Fla.-based company won the same designation for MagicTouch for the treatment of coronary in-stent restenosis in April. Get the full story on our sister […]
Misonix lands CE Mark for Nexus ultrasonic platform
Misonix (NSDQ:MSON) said today that it has received the CE Mark for a new ultrasonic surgical platform. The Nexus platform combines all the features of Misonix’s existing solutions, including BoneScalpel, SonicOne and Sonastar, into a single, fully integrated platform that was also designed to accommodate future solutions. The Nexus platform is driven by a new […]
FDA slaps Class I label on Fresenius Kabi USA infusion pump recall
The FDA has designated a recall of Fresenius Kabi USA infusion devices and software as Class I, the most serious type of recall. In June, Fresenius Kabi USA voluntarily began the recall of its Volumat MC Agilia volumetric infusion pump to upgrade an alarm that signals when the infusion is complete, and of its Vigilant […]
Transcatheter mitral valve tech dev CardioMech AS raises $5m
CardioMech AS said today that it has raised another $5 million in a heavily oversubscribed convertible note funding round, bringing its total raised during 2019 to $7.5 million. Experienced medtech investors participated in the round, whose proceeds will be used to further accelerate the development of its transcatheter mitral valve technology, according to the early-stage […]
Denmark’s Ambu settles U.S. trade violations for $3.3 million
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 […]
Ancora Heart launches AccuCinch study in Europe
Ancora Heart said today that the first patient was enrolled in a European multi-center clinical evaluation of its AccuCinch ventricular repair system intended for treating patients with reduced ejection fraction systolic heart failure. The first patient was enrolled at Homolka Hospital in Prague, Czech Republic, by Dr. Petr Neužil, head of the hospital’s cardiology department […]
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, […]