Bright Uro raises $23M Series A to support urodynamics system
Bright Uro announced today that it closed $23 million in a Series A funding round to support its Glean urodynamics system. Irvine, California-based Bright Uro plans to use the funding to help garner FDA 510(k) clearance...
Bright Uro raises $23M Series A to support urodynamics system
Bright Uro announced today that it closed $23 million in a Series A funding round to support its Glean urodynamics system. Irvine, California-based Bright Uro plans...
BiVACOR wins IDE to start first-in-human study for artificial heart
The US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) to BiVACOR’s total artificial heart (BTAH), greenlighting the way for...
ScandiDos quality system receives MDR certification
ScandiDos, a provider of patient-specific quality assurance solutions, has attained certification under the European Union Medical Device Regulation (MDR) for its quality system and...
Stille has entered into an agreement to acquire Fehling Instruments
Stille AB (publ) ("Stille" or the "Company") has entered into an agreement to acquire all shares outstanding of Fehling Instruments GmbH & Co. KG and Fehling Verwaltungs GmbH (jointly...
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Finance
Clinical Trials
BiVACOR wins IDE to start first-in-human study for artificial heart
The US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) to BiVACOR’s total artificial heart (BTAH), greenlighting the way for...
Paragonix completes first-in-human use of lung preservation system
Paragonix Technologies has announced the completion of the world’s first-in-human use of the BAROguard Donor Lung Preservation System by Duke University Medical Center in the US. Earlier...
Xeltis reveals 12-month trial data for aXess haemodialysis access graft
The Netherlands-based medtech Xeltis has presented trial results for its aXess haemodialysis access graft showing 0% infection rates at 12 months. The data from the...
Avation Medical confirm safety and efficacy data on smart bladder control system
Avation Medical has announced positive results from the multi-centre trial of Vivally, its medical device to treat overactive bladder (OAB) syndrome. The FREEOAB multi-centre study...
Regulatory Approvals
Bright Uro raises $23M Series A to support urodynamics system
Bright Uro announced today that it closed $23 million in a Series A funding round to support its Glean urodynamics system. Irvine, California-based Bright Uro plans...
BiVACOR wins IDE to start first-in-human study for artificial heart
The US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) to BiVACOR’s total artificial heart (BTAH), greenlighting the way for...
ScandiDos quality system receives MDR certification
ScandiDos, a provider of patient-specific quality assurance solutions, has attained certification under the European Union Medical Device Regulation (MDR) for its quality system and...
Stille has entered into an agreement to acquire Fehling Instruments
Stille AB (publ) ("Stille" or the "Company") has entered into an agreement to acquire all shares outstanding of Fehling Instruments GmbH & Co. KG and Fehling Verwaltungs GmbH (jointly...
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