
Medical Devices DECODED
Latest edition: 01 Dec 2023
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Spotlight
Johnson & Johnson MedTech acquires heart implant company Laminar for $400m
The deal, which will also include potential clinical and regulatory milestone payments in 2024 and beyond, will see Laminar join J&J’s Biosense Webster division.

Latest news

Proximie announce blueprint to digitalise operating rooms at Slush
Proximie’s software development kit (SDK) will be used by surgeons, healthcare organisations and medical device companies to advance the field of surgery.

Empatica launches clinical trial to predict refractory seizures with AI
The trial will build data to help Empatica’s wearable tech identify a form of seizure that can occur when medications stop working.

Alafair Biosciences's VersaWrap device receives FDA 510(k) clearance
The clearance allows paediatric surgeons and medical facilities to treat younger patients using the VersaWrap Class II medical device.

Balancing regulation and innovation in laboratory-developed tests
The new proposed rule published in October 2023 states the FDA’s intention to regulate LDTs, including those that are manufactured by a laboratory.

BD introduces new ultrasound system for clinicians
The SiteRite 9 vascular access ultrasound system comprises integrated visualisation tools.

Nevro acquires medical technology company Vyrsa
Established in 2021, Vyrsa offers sacroiliac (SI) joint fusion devices approved by the US Food and Drug Administration (FDA).

Argon Medical introduces Kodiak kit for vascular procedures
The device is designed to precisely introduce diagnostic and therapeutic devices into the vasculature in a streamlined manner.

Amgen and MSD-backed start-up wins $10m for drug and device development
Culmination Bio has a library of electronic health records and biospecimen data that help in drug and diagnostic device development.
In our previous edition

Medical Devices Decoded
FDA urged to drop proposed rule change for Laboratory Developed Tests
30 Nov 2023

Medical Devices Decoded
Phillips woes worsen, FDA issues overheating safety warning for CPAP machine
29 Nov 2023

Medical Devices Decoded
Myocenesigns contract with OGC Nice football club
28 Nov 2023
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