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BioWorld - Sunday, June 28, 2026
Home » Topics » Respiratory, Medical technology

Respiratory, Medical technology
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Synapse gains EUA from FDA to stimulate the diaphragm of ventilated patients

April 16, 2020
By Stacy Lawrence
Case Western Reserve University spinout Synapse Biomedical Inc. has received emergency use authorization from the U.S. FDA for its Transaeris diaphragm pacing system (DPS) device to prevent and treat ventilator-induced diaphragm dysfunction (VIDD).
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Asclepius Meditec develops hydrogen-oxygen nebulizer to tackle COVID-19

April 14, 2020
By Elise Mak
BEIJING – Med-tech firm Shanghai Asclepius Meditec Co. Ltd. says it has developed a hydrogen-oxygen nebulizer that can help relieve the shortage of ventilators, highlighting the potential of hydrogen-oxygen therapy in tackling COVID-19. Named the AMS-H-03, this class III medical respiratory device can produce three liters of mixed gas containing hydrogen and oxygen by using water electrolysis and can run continuously for 24 hours, according to the company.
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French manufacturing consortium to produce 10,000 ventilators in 50 days

April 9, 2020
By Bernard Banga
PARIS – Medical gases specialists Air Liquide SA, of Paris, along with Peugeot SA, Schneider Electric SE and Valeo SA have joined together in a consortium to manufacture ventilators in a time when there is a critical shortage.
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Vapotherm’s Oxygen Assist Module wins FDA breakthrough device nod

April 9, 2020
By Meg Bryant
The U.S. FDA has granted breakthrough device designation to Vapotherm Inc. for its Oxygen Assist Module (OAM), for use with its Precision Flow assistive breathing systems. The new module is designed to aid clinicians in maintaining a targeted blood oxygen range in patients requiring oxygen therapy.
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CT scans interpreted by AI can help diagnose coronavirus

April 1, 2020
By Annette Boyle
An artificial intelligence-based system can accurately detect COVID-19 using thoracic CT scans in patients with respiratory symptoms, according to a preprint study published on arXiv.org. The system can also help monitor patients with the disease. Other teams have employed AI to speed diagnosis and develop clarity on the signature appearance of the disease in the lungs of symptomatic patients.
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FDA nod for ABM Respiratory Care’s Biwaze Cough system

April 1, 2020
By Meg Bryant
Charleston, S.C.-based startup ABM Respiratory Care has received U.S. FDA clearance for its first product, an airway clearance system known as Biwaze Cough. The portable device helps to remove secretions for people who are unable to cough or clear away secretions effectively on their own due to injury or disease.
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COVID-19 is causing supply issues for ventilators in France

March 25, 2020
By Bernard Banga
PARIS – With more than 10,000 people now infected, 3,626 hospitalized and 450 having died, France is in third place of European countries most affected by the coronavirus epidemic, after Italy (35,700 cases) and Spain (13,910 cases). The exponential spread of COVID-19 has led to a surge in demand for respiratory therapy equipment in intensive care units.
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Major ventilator makers ramp production, even as alternatives sought to fill massive shortfall

March 19, 2020
By Stacy Lawrence
As COVID-19 testing remains elusive in the U.S., much of the nation’s focus has started to shift to how to treat the presumed millions of patients who are already or soon to be infected with the novel coronavirus.
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Beyond Air seeks IDE for nitric oxide treatment for COVID-19

March 17, 2020
By Meg Bryant
As companies scramble to develop diagnostic tests and vaccines for COVID-19, there is a need for effective treatments for patients suffering severe respiratory effects from the novel coronavirus. To that end, Beyond Air Inc., of Garden City, N.Y., and Rehovot, Israel, has applied to the U.S. FDA to conduct an IDE trial of its inhaled nitric oxide (NO) system, Lungfit Bro, in COVID-19 patients.
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Behold.ai secures 510(k) for Red Dot image recognition algorithm

March 17, 2020
By Nuala Moran
LONDON – Behold.ai Ltd. has secured U.S. FDA 510(k) approval for use of its Red Dot image recognition algorithm in the automatic diagnosis of life-threatening pneumothorax (collapsed lung). The product completes the analysis immediately, sending an alert to the radiologist as soon as an X-ray is taken. “It does in 30 seconds what would normally take up to 30 minutes,” said Simon Rasalingham, CEO of London-based Behold.ai.
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