The FDA has granted emergency use authorization to Synapse Biomedical (Oberlin, Ohio) for its TransAeris diaphragmatic pacing stimulator to help wean COVID-19 patients off of ventilators. TransAeris is the first system authorized by the FDA to perform such a task. The 30-day authorization is aimed at patients considered at high risk of weaning failure. It […]
From Attune Medical receiving FDA 510(k) clearance to Synapse Medical having CE Mark approval, here are 5 medtech stories we missed this week but thought were still worth mentioning. 1. Attune Medical gets FDA 510(k) clearance Attune Medical announced in a Jan. 8 press release that it has received FDA 510(k) clearance for its EnsoETM […]
Synapse Biomedical said today it won a GSA schedule 65IIA contract which will allow it to supply its NeuRX diaphragm pacing system to Veterans Affairs hospitals. The Oberlin, Ohio-based company said the approval will allow it to place its NeuRx device, designed to provide electrical stimulation to the muscles and nerves of the diaphragm, in to […]
Synapse Biomedical said yesterday it signed a development deal with Case Western Reserve University to commercialize its neurostimulation device. The deal is being supported by a $3 million grant from the Ohio 3rd Frontier Innovation Platform Program, according to Synapse. “Synapse is proud to be part of this endeavor under the funding of the Third […]
Synapse Biomedical said it landed $2.4 million in funding from the Ohio Third Frontier Commission for the next generation of its NeuRx technology.
The NeuRx device is designed to provide electrical stimulation to the muscles and nerves of the diaphragm. It won FDA approval in 2008, and again in 2011, specifically for treating chronic hypoventilation from amyotrophic lateral sclerosis.
MASSDEVICE ON CALL — The U.S. Senate last night voted 92-4 to approve the latest iteration of the Medical Device User Fee & Modernization Act, which was bundled in a larger FDA user fee measure.
Lawmakers agreed to push forward the bill, which will now head to the White House for a signature from President Barack Obama before becoming law.
Synapse Biomedical Inc. received Humanitarian Use Device approval from the Food & Drug Administration for the company’s NeuRx Diaphragm Pacing System in certain ALS patients.
Under the approval, the device that stimulates the diaphragm to contract — simulating a breathing motion — can be used for amyotrophic lateral sclerosis patients who have stimulatable diaphragms and inadequate breathing.