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Amgen and MSD-backed start-up wins $10m for drug and device development
Culmination Bio has secured $10m in investment from the Merck Global Health Innovation Fund (venture capital arm of MSD) and …
MSD reinforces Amazon partnership for faster AI-led drug discovery and development
Merck & Co (MSD) is continuing its multi-year cloud migration to Amazon’s cloud computing subsidiary Amazon Web Services (AWS), as …
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), …
Modus X robotic exoscope breaks into Europe
Canada-based medical device company Synaptive Medical has revealed its Modus X robotic exoscope, a high-definition digital imaging system to the …
FDA urged to drop proposed rule change for Laboratory Developed Tests
The Utah University-based ARUP Laboratories is calling on the US Food and Drug Administration (FDA) to reverse its decision to …
Dimension Inx treats first patients with 3D regenerative bone graft
Chicago-based regenerative therapeutics firm Dimension Inx has successfully implanted its CMFlex material in multiple patients. The 3D-printed regenerative bone graft product, …
Thermo Fisher and Flagship Pioneering partner to establish platform companies
Thermo Fisher has announced a new partnership with biotechnology company Flagship Pioneering to establish a string of platform companies. The platform …
Unomedical’s VariSoft’s insulin infusion hit with FDA Class I recall tag
In a year that has seen a multitude of medical device recalls, Unomedical is the latest company to land a …
Philips woes worsen, FDA issues overheating safety warning for CPAP machine
The US Food and Drug Administration (FDA) has issued a safety warning regarding the risk of overheating for the Philips …
Philips launches new MR Smart Fit coils at RSNA
Royal Philips has introduced three new magnetic resonance (MR) Smart Fit coils at the Radiological Society of North America (RSNA), …
First surgeries testing rotator cuff augmentation implant carried out in Florida
The first surgeries testing an implant system designed to protect injured tendons have been successfully carried out at a Florida …
Clario introduces AI-powered tool for cardiac safety evaluations in trials
Clario has introduced the ECG Quality Score tool, powered by artificial intelligence (AI), for improving cardiac safety evaluations in clinical …
Spinal Elements introduces Ventana 3D-Printed Interbody portfolio
Spine technology company Spinal Elements has commercially introduced its Ventana 3D-Printed Interbody portfolio. The portfolio, which has been launched completely, consists …
Penumbra enrols first patient in trial of Lightning Flash
Penumbra has enrolled the first patient in the STORM-PE study, which is designed to assess anticoagulation alone against anticoagulation plus …
Inflammatix receives breakthrough device designation for TriVerity system
Inflammatix has received breakthrough device designation from the US Food and Drug Administration (FDA) for its TriVerity acute infection and …