NASA is ready to begin testing the E-Nose COVID-19 screening device prototype developed by subcontractor Variable Inc., of Chattanooga, Tenn. NASA received $3.8 million from the Department of Health and Human Services to enhance E-Nose, which was originally developed to measure air quality inside spacecraft. The updated version is intended to facilitate screening for SARS-CoV-2 by "sniffing out" the signature volatile organic compounds (VOCs) in the breath of infected individuals.
Bronchoscopic thermal vapor ablation (BTVA) destroyed lung tumors without significant safety issues, according to a study published in Respiration. The minimally invasive ablation procedure took 12 minutes using Uptake Medical Technology Inc.’s Intervapor system in the Vaporize study. Uptake is a subsidiary of San Jose, Calif.-based Broncus Medical Inc.
The management team at Respinova Ltd. is breathing easier with the FDA's 510(k) clearance of the company's Pulsehaler. Using pulsed air pressure, the device opens airways and clears secretions in patients with respiratory diseases. The clearance represents the device’s first endorsement by a regulatory agency, though the company hopes it will soon be joined by others.
Pixium Vision SA reported that its merger with Second Sight Medical Products Inc. has foundered. The combination would have eased Paris-based Pixium’s entry into the U.S. market and Sylmar, Calif.-based Second Sight’s access to the European market, which Pixium has previously opposed, and enabled them to jointly develop and market neuromodulation devices that restore some degree of vision to the blind. The deal had been expected to close early in the second quarter of 2021.
Nevro Corp.'s spinal cord stimulation system cut diabetic neuropathy pain in half or more in 85% of patients in a study published on April 5 in JAMA Neurology. Patients receiving the stimulation treatment delivered by the Senza system experienced an average reduction in pain of 76% at six months in the largest clinical largest trial to date to evaluate the use of spinal cord stimulation (SCS) in painful diabetic neuropathy (PDN).
Merck & Co. Inc. telegraphed the future focus of Organon & Co., which will spin off from the pharmaceutical giant as a public company in the first half of 2021, with an announcement of an agreement to acquire Alydia Health Inc. Alydia makes the Jada system, which treats postpartum hemorrhage.
The FDA granted breakthrough device designation status to Neuropace Inc.'s responsive neurostimulation (RNS) system for idiopathic generalized epilepsy, a subtype that represents about one-third of all epilepsies. The news closely follows the company’s March 24, 2021, SEC filing to raise $75 million in an initial public offering on the Nasdaq.
The FDA authorized marketing of the Portable Neuromodulation Stimulator (Pons) for short-term treatment of gait issues arising from mild to moderate symptoms associated with multiple sclerosis (MS) through its de novo pathway. Helius Medical Inc., a subsidiary of Helius Medical Technologies Inc., makes the non-implantable neuromuscular tongue stimulator.
The FDA approved the world's first non-surgical heart valve to treat severe pulmonary valve regurgitation, which often affects individuals with congenital heart disease. Medtronic plc’s Harmony transcatheter pulmonary valve system (TPV) improves blood flow to the lungs without open-heart surgery. The device could extend the time before an individual born with heart disease needs open-heart surgery and the total number of such surgeries they have to endure over their lifetime.
South San Francsico-based Twist Bioscience Corp. and Biotia Inc., of New York, received the first FDA emergency use authorization (EUA) for a capture-based next-generation sequencing (NGS) assay for the coronavirus that causes COVID-19. The technique reduces the likelihood of misdiagnosing or failing to identify mutations compared to standard sequencing.
