Teleflex (NYSE:TFX) is recalling its Neonatal ConchaSmart breathing circuit with dual heated limb and ConchaSmart Column due to complaints of cracks being observed, prior to use, on the device’s swivel wye adaptors. Cracks in the adaptor may cause breathing distress from insufficient oxygenation because the gas may leak and not reach the patient. The FDA has […]
Teva wins FDA approval for AirDuo Digihaler for asthma
Teva (NYSE:TEVA) yesterday said that it received FDA approval for its AirDuo Digihaler Inhalation Powder. The Israel-based company’s AirDuo Digihaler is a combination therapy digital inhaler with built-in sensors that can connect to a smartphone application, indicated to treat asthma in people 12 years and older.. It delivers a multi-dose dry powder of 113mcg of fluticasone […]
Hamilton Medical recalls ventilators over software glitch
Swiss device maker Hamilton Medical is recalling more than 4,300 ventilators due to a software failure that shuts off the machines, according to the FDA. Hamilton G-5 ventilators manufactured between November 29, 2007 and October 31, 2018 may display a “panel connection lost” error message that causes the machine to stop working and leaves patients […]
Inspire Medical scores reimbursement win from UnitedHealth
Inspire Medical Systems (NYSE:INSP) logged another reimbursement win, this time with the nation’s largest private insurer, UnitedHealth. Minneapolis-based Inspire makes an eponymous device designed to treat obstructive sleep apnea using hypoglossal nerve stimulation. UnitedHealth has about 41 million lives under coverage, Inspire said. “We are very pleased to receive this positive coverage decision from UnitedHealthcare. […]
Vectura seeks another $44M in GSK patent win
Fresh off its $89.7 million jury award in a patent infringement case against GlaxoSmithKline (NYSE:GSK), British inhaler company Vectura has petitioned the court for an additional $44 million. On May 16, a jury in U.S. District Court for the District of Delaware awarded Vectura damages for the period from August 2016 through December 2018 for an infringement […]
Two deaths reported in recall of 6 million Teleflex endotracheal tubes
Teleflex (NYSE:TFX) is recalling multiple models of its Hudson RCI Sheridan and Sheridan endotracheal tubes due to complaints of the Sheridan connector disconnecting from the breathing circuit. Two deaths and one injury have been reported to the company, according to the FDA. Each of the more than 6 million recalled tracheal tubes includes an appropriately sized […]
ResMed study shows 170 million in Americas have sleep apnea
More than 170 million people in North and South America have sleep apnea, according to a new study released today by apnea device-maker ResMed (NYSE:RMD). The company reached the 170 million figure based on the American Academy of Sleep Medicine (AASM) 2012 criteria and termed it a “conservative” estimate. The figure represents 37% of adults […]
Windtree, Eleison tout feasibility study results
Windtree Therapeutics (OTCQB:WINT) and Eleison Pharmaceuticals have announced positive results of a feasibility study using Windtree’s aerosol delivery system (ADS) to deliver Eleison’s inhaled lipid cisplatin (ILC) for lung cancer. In the study, the ADS technology produced in 20 minutes approximately the same volume of aerosolized ILC that required approximately two hours to produce in a phase 2 […]
Report: Apple acquires pediatric asthma monitor dev Tueo Health
Apple (NSDQ:AAPL) has acquired pediatric asthma monitoring start-up Tueo Health, according to a recent CNBC report. Tueo Health was founded out of a Stanford-based incubator in 2015, according to a Stanford Byers Center for Biodesign posting, and was developing a mobile application intended to operate with commercial breathing sensors to monitor and help manage asthma symptoms […]
J&J’s Auris touts Monarch robotic bronchoscopy feasibility study
Johnson & Johnson‘s (NYSE:JNJ) Auris Health touted this week interim results from an independent feasibility study designed to assess the company’s Monarch robotic bronchoscopy technology. The Monarch Platform was cleared by the FDA in March 2018 for diagnostic and therapeutic bronchoscopic procedures. The study was set up to test the safety and feasibility of performing […]
5 ways medtech research aims to help veterans
As the United States prepares to honor its war dead on Memorial Day, medtech researchers are working to help survivors wounded in battle, both in body and mind. Whether the research comes out of government, industry or academia, there’s also a desire to help veterans facing other health challenges. The work is evolving. 3D printing […]
- 1
- 2
- 3
- …
- 55
- Next Page »
MassDevice Network
@MassDevice
LinkedIn
YouTube