Thoracic/Respiratory

Hill-Rom Holdings, Inc. has received 510(k) clearance from the U.S. FDA to market the MetaNeb® 4.0 airway clearance system. The system helps enhance normal mucus clearance from the lungs, delivers lung expansion therapy, and assists in the treatment and prevention of pulmonary atelectasis, a complete or partial collapse of the lung.

The FDA has issued a warning to healthcare professionals that stolen Covidien stapler reloads may be in circulation. The reloads are labelled sterile, but were stolen from the company prior to sterilisation taking place.

A second of the companies heading down the FDA’s new Early Feasibility Pilot Study route is Texan outfit BiO2 with its clever anti-embolic Angel Catheter. Strikingly, as the study gets the FDA’s nod to commence, the device is already on the market in Europe.

Israeli company ETView has been granted US FDA 510(k) clearance for an expanded size range of its VivaSight™-DL Airway Management System. The company currently distributes the VivaSight™-DL Airway Management System in the US.

Covidien has voluntarily recalled certain Power Pac batteries for its Newport™ HT70 and HT70 Plus ventilators following customers reporting units alarming and switching to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery.

One of those promotional hook-ups that makes perfect sense sees Covidien agree to start distributing Vida Diagnostic’s interventional pulmonology diagnostic and planning software alongside its own i-Logic advanced bronchoscopy system.

The U.S. FDA has cleared Angiotech’s Bio-Seal Lung Biopsy Tract Plug System, a device that seals punctures left by biopsies performed to confirm a diagnosis of suspected lung conditions.

Volcano Corporation has signed an agreement to acquire Crux Biomedical, a privately-held company that has developed a highly differentiated inferior vena cava (IVC) filter—the Crux VCF System—to treat pulmonary embolisms (PE’s).

Revolutionary experimental technology that allows donor hearts to be delivered to transplant recipients warm and beating rather than frozen in an ice cooler is now being used to deliver “breathing lungs.” A UCLA Medical team has successfully performed the nation’s first “breathing lung” transplant.

Medtronic’s Valiant Thoracic Stent Graft has become the second device to be FDA approved for use in all descending thoracic aortic aneurysms without dissections.

Researchers have reported that last week a first patient in the United States was treated in a late-stage clinical trial of the AeriSeal foam sealant System to treat emphysema.

Varian Medical Systems has been showcasing the company’s technologies for the non-invasive treatment of lung cancer at the 54th annual meeting of the American Society for Radiation Oncology (ASTRO) in Boston this week.

Neomend reckons its PEG-based spray-on sealant has many applications. Presumably so does Bard, which has just announced the purchase of the California-based outfit.

Teleflex Incorporated has announced that its Rusch® EZ-Blocker™ Disposable Endobronchial Blocker has received FDA 510(k) clearance. The product is designed to allow for safer and easier lung isolation and one lung ventilation.

Covidien has announced U.S. FDA 510(k) clearance and CE Mark approval for its next generation of Nellcor™ Bedside Respiratory Patient Monitoring system.

Bolton Medical has announced the FDA’s approval of its Relay® Thoracic Stent-Graft with Plus Delivery System. The device is designed to address the needs of physicians performing minimally invasive surgery for thoracic aortic aneurysms and penetrating ulcers.