FDA Clears Heart-Lung Machine for Cardiopulmonary Bypass
With the FDA clearance, the London-based company, which is initiating a commercial release in Europe, plans to begin rolling out the equipment in the US.
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FDA: Reworked Philips Trilogy Ventilators Have Additional Safety Issues
The FDA reports that Philips Trilogy ventilators reworked as a part of the June 2021 recall have two new potential issues that may affect performance and safety.
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Werfen Launches GEMweb Live Real-time Diagnostics Dashboard
Werfen has released GEMweb Live, a real-time onscreen viewer of diagnostic test results for cardiac surgical procedures.
Dayton Children’s Hospital Contracts Medline as Laboratory Prime Vendor
Medline has been selected as Dayton Children’s Hospital’s laboratory prime vendor, entering into a multi-year agreement.
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Philips Recall Expands to All V60, V60 Plus Ventilators
Philips Respironics is recalling all V60 and V60 Plus ventilators because an internal power fluctuation may cause the ventilator to shut down unintentionally either with or without any visible or audible alarms, according to an FDA recall alert.
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Class I Recall for Hillrom Volara System
Baxter International Inc has issued an Urgent Medical Device Correction for the Hillrom Volara System (home care) over a possible risk of oxygen desaturation or barotrauma.
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Dale Introduces BreezeLock Endotracheal Tube Holder
Dale Medical Products has introduced its new BreezeLock Endotracheal Tube Holder, featuring a soft, comfortable, flexible neckband with no hard plastic parts.
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Premier Inc Contracts Olympus Single-use Bronchoscopes
The Olympus single-use bronchoscope portfolio is made up of five premium H-SteriScope single-use bronchoscopes that can be used in complement with the company’s reusable bronchoscope portfolio.
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FDA Clearance for Cellvizio + Pafolacianine for Molecular Imaging
The FDA granted 510(k) clearance for the use of the Cellvizio 100 Series platform with a molecular imaging agent called Pafolacianine (Cytalux) for real-time in vivo visualization during endoscopic, laparoscopic, and needle-based procedures.
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Philips Respironics Issues Voluntary Recall Notification for V60 Ventilators
customers of its V60/V60 Plus and V680 ventilators about a potential issue with the electrical circuit in these ventilators that controls the 35V power supply to the ventilator and alarm.
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First COVID-19 Breathalyzer Test Authorized by FDA
The FDA authorized the InspectIR COVID-19 Breathalyzer — the first COVID test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection.
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Wellinks COPD Management App Effectively Engaged Older Adults
A study of the Wellinks virtual COPD management solution found that older adults with COPD were highly engaged and satisfied with the mobile app.
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Caire Portable Oxygen Concentrator Outperforms Competitors
The Caire portable oxygen concentrator FreeStyle Comfort outperformed other market leading devices in a study assessing COPD oxygen delivery.
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Class I Recall Issued for Philips V60 and V60 Plus Ventilators
Philips Respironics is recalling certain V60 and V60 Plus ventilators due to an expired adhesive in what the FDA has labeled a Class I recall.
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Olympus to Supply Vizient Network with Single-use Bronchoscopes
The Olympus single-use bronchoscope portfolio is made up of the five premium H-SteriScope single-use bronchoscopes that can be used with the company’s leading reusable bronchoscope portfolio.
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