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Signal: Illumina may be on its way to divest Grail, but legal trouble looms
Diagnostics giant Illumina could seek an outright sale of Grail, a cancer detection test manufacturer. In an interview on 28 November …
BlueSkeye AI to begin trial of AI mental health app for perinatal depression
The Medical and Healthcare products Regulatory Agency (MHRA) has greenlit BlueSkeye AI to begin a clinical trial investigating its TrueBlue …
Johnson & Johnson MedTech acquires heart implant company Laminar for $400m
Johnson & Johnson (J&J) MedTech has made an upfront payment of $400m to acquire the privately held company Laminar, a …
Empatica launches clinical trial to predict refractory seizures with AI
Wearable tech firm Empatica has announced it is developing a clinical trial intent on using artificial intelligence (AI) and wearable …
Proximie announce blueprint to digitalise operating rooms at Slush
Proximie has launched its software development kit (SDK), which is focused on digitising operating and diagnostic rooms. The healthcare platform combines …
Balancing regulation and innovation in laboratory-developed tests
The landscape of laboratory-developed tests (LDTs) is facing a significant regulatory shift as the US Food and Drug Administration (FDA) …
Alafair Biosciences’s VersaWrap device receives FDA 510(k) clearance
Alafair Biosciences has received 510(k) clearance from the US Food and Drug Administration (FDA) for its VersaWrap class II medical …
BD introduces new ultrasound system for clinicians
Becton, Dickinson and Company (BD) has introduced SiteRite 9, an advanced vascular access ultrasound system to help increase clinician efficiency. The …
Nevro acquires medical technology company Vyrsa
Nevro has acquired medical technology company Vyrsa Technologies in a deal valued at around $75m. As per the transaction, Nevro made …
Argon Medical introduces Kodiak kit for vascular procedures
US-based Argon Medical Devices has launched the Kodiak Dual Port Coaxial Introducer Kit to support complex vascular procedures. The device is …
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 …