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Synapse Biomedical Inc.

Synapse Biomedical wins emergency nod for ventilator-weaning device

April 15, 2020 By Nancy Crotti

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Respiratory Tagged With: coronavirus, COVID-19, FDA, Synapse Biomedical Inc.

5 medtech stories we missed this week: Jan. 26, 2018

January 26, 2018 By Danielle Kirsh

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 […]

Filed Under: 510(k), Food & Drug Administration (FDA), Hospital Care, Neuromodulation/Neurostimulation, Regulatory/Compliance, Respiratory Tagged With: Ally Bridge Group, Attune Medical, Axonics Modulation Technologies, LifeTech Scientific Corp., MedTech, ResMed Inc., Synapse Biomedical Inc.

Synapse Biomedical wins VA nod for NeuRx diaphragm pacing system

August 9, 2016 By Fink Densford

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 […]

Filed Under: Business/Financial News, Neuromodulation/Neurostimulation Tagged With: Synapse Biomedical Inc.

Synapse, Case Western ink neurostim development deal

October 16, 2015 By Fink Densford

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 […]

Filed Under: Business/Financial News, Neuromodulation/Neurostimulation Tagged With: Synapse Biomedical Inc.

Synapse Biomedical lands $2M

December 23, 2013 By Chris Walker Leave a Comment

Synapse Biomedical lands $2M in funding

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.

Filed Under: Funding Roundup, News Well, Respiratory Tagged With: Ohio Third Frontier, Synapse Biomedical Inc.

FDA user fee bill heads to the White House | MassDevice.com On Call

June 27, 2012 By MassDevice staff Leave a Comment

MassDevice On Call

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.

Filed Under: Food & Drug Administration (FDA), Healthcare Reform, Neurological, News Well Tagged With: Boston Scientific, MDUFMA, On Call, Synapse Biomedical Inc., U.S. Congress, White House

Northeast Ohio attracts neurotech cluster

January 14, 2011 By MedCity News Leave a Comment

Cleveland Clinic neuromodulation spinoff Intelect Medical may have stealthily exited Cleveland to set up shop in Boston, but the company’s recent $78 million sale to Boston Scientific (NYSE:BSX) highlights Northeast Ohio’s growing strength in neurotechnology.

Filed Under: Business/Financial News, Neurological, Neuromodulation/Neurostimulation, News Well Tagged With: Checkpoint Surgical, Cleveland Clinic, CleveMed, NDI Medical, Neuros Medical Inc., NeuroWave Systems Inc., Synapse Biomedical Inc.

Synapse wins FDA nod for ALS treatment

October 12, 2010 By MedCity News Leave a Comment

MedCity News logo

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.

Filed Under: Business/Financial News, Neurological, News Well Tagged With: Synapse Biomedical Inc.

Synapse Biomedical aims to raise $1.2 million in Series C round

January 21, 2010 By MedCity News Leave a Comment

By Mary Vanac

MedCity News logoOBERLIN, Ohio — Synapse Biomedical Inc. raised more than $433,000 from investors on its way to $1.2 million to repay debt and get ready to supply its diaphragm pacing technology to a new market: ALS patients.

Filed Under: Business/Financial News, Neurological, News Well Tagged With: Synapse Biomedical Inc.

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