The FDA classified Medtronic‘s (NYSE:MDT) recall of certain lots of its Shiley neonatal and pediatric tracheostomy tubes as Class I, the most serious type of recall issued by the federal watchdog. A Class I label from the FDA indicates that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.” […]
Respiratory
Philips touts managed care data for COPD treatment
Royal Philips (NYSE:PHG) said today new research reports that non-invasive ventilation is a key part of a multi-faceted interventional approach to reduce readmission rates among chronic obstructive pulmonary disease patients. The study, supported by Philips and published in the Journal of Clinical Sleep Medicine, examined COPD patients hospitalized 2+ times a year who transitioned to […]
Medtronic launches lung biopsy device
Medtronic (NYSE:MDT) said today it launched the GenCut core lung biopsy system designed for use with its superDimension navigation system. The system allows for surgeons to collect multiple core samples from difficult-to-reach areas in the lung, which can decrease procedure times, the Fridley, Minn.-based company said. GenCut’s new blade design also allows for larger, more intact […]
Pulmonx touts sham trial data
Pulmonx said earlier this month that a sham-controlled trial of its Zephyr endobronchial valve met and exceeded its primary endpoints, reporting a 20.9% average improvement in lung function. The Believer-Hifi study, published in The Lancet, is the 1st successful sham-controlled trial of any invasive emphysema device, Redwood City, Calif.-based Pulmonx said. “We have been able […]
Circadiance buys Philips’ infant sleep apnea lines
Circadiance said yesterday it acquired Royal Philips‘ (NYSE:PHG) infant respiratory SmartMonitor and NeoPap product lines. The companies did not disclose the details of the transaction, but Circadiance said they anticipate the deal to close by the end of the week. The purchase will allow the company to expand its presence into the global pediatric […]
ResMed picks up home medical re-supplier CareTouch
ResMed (NYSE:RMD) said today that it acquired home medical re-supplier CareTouch for an undisclosed amount. San Diego-based ResMed said it plans to re-brand CareTouch as ResMed ReSupply, but retain CEO Matthew Dolph and other CareTouch employees as part of its Americas commercial team. Westminster, Colo.-based CareTouch’s Internet-based 360 Portal is designed to help home medical equipment providers manage […]
Teleflex recalls Hudson RCI manual resuscitator
Teleflex (NYSE:TFX) is recalling its Hudson RCI Lifesaver single patient use manual resuscitator, according to an FDA posting. The Wayne, Penn.-based company began notifying customers of the issue on May 14. The FDA has labeled the recall as a Class I, the most serious type of recall issued by the federal watchdog, which indicates “there is a reasonable […]
Maquet recalls Flow-i anesthesia systems
Maquet Cardiovascular, Getinge‘s (PINK:GETI B) medical subsidiary, is recalling its Flow-i anesthesia systems according to an FDA posting. The company began notifying customers of the product recall on April 2. The FDA labeled the recall a Class I, the most serious type of recall issued by the federal watchdog, indicating that “there is a reasonable […]
Imthera Medical opens $10m financing round
ImThera Medical has opened for a $10 million equity financing round, according to an SEC filing posted last Friday. The company’s flagship product is the Aura6000, an implanted hypoglossal nerve stimulator for sleep apnea that won FDA investigational device exemption in November 2014. ImThera Medical has already raised $2.7 million from 29 investors, according to the SEC filing from […]
Teleflex recalls neonate manual resuscitator
Teleflex (NYSE:TFX) said yesterday it is recalling its Hudson RCI Lifesaver neonate manual resuscitator. The company said it began notifying hospitals and distributors of the recall on May 14. The FDA labeled it a Class I recall, the most serious type of recall issued by the federal watchdog, indicating that “there is a reasonable probability that use of these […]
BMC claims another win in patent war with ResMed
BMC Medical said Tuesday that it won a European litigation against ResMed (NYSE:RMD) over an infringed patent for a continuous positive airway pressure respiratory system machine with a detachable water tank. The dispute is part of a long-standing conflict over sleep apnea devices between the 2 companies. The 1st District Court of Munich lifted a preliminary injunction […]