Alafair’s VersaWrap device receives FDA 510(k) clearance
The VersaWrap is primarily utilised in a range of tendon and peripheral nerve treatments. Credit: Alafair Biosciences/PRNewswire. Alafair Biosciences has received 510(k) clearance from the US Food and Drug Administration (FDA) for its VersaWrap class II medical device. The approval enables application of the bioresorbable hydrogel implant in all patient populations, irrespective of their age. […]
Argon Medical introduces Kodiak kit for vascular procedures
Argon’s Kodiak Dual Port Coaxial Introducer Kit. Credit: Argon Medical Devices/PRNewswire. US-based Argon Medical Devices has launched the Kodiak Dual Port Coaxial Introducer Kit to support complex vascular procedures. The device is designed to precisely introduce diagnostic and therapeutic devices into the vasculature in a streamlined manner. Argon Medical president and CEO George Leondis said: […]
Nevro acquires medical technology company Vyrsa
Vyrsa provides a less invasive treatment for individuals with chronic sacroiliac joint pain. Credit: BlurryMe / Shutterstock.com. Nevro has acquired medical technology company Vyrsa Technologies in a deal valued at around $75m. As per the transaction, Nevro made a $40m payment at closing and committed up to an additional $35m, either in cash or stock, […]
Amgen and MSD-backed start-up wins $10m for drug and device development
Culmination Bio has a library of multimodal and longitudinal data, along with the accompanying biospecimens. Image Credit: elenabsl / Shutterstock. Culmination Bio has secured $10m in investment from the Merck Global Health Innovation Fund (venture capital arm of MSD) and Amgen Ventures to develop an intelligence platform to facilitate diagnostic and therapeutic development. The US-based […]
BiVACOR wins IDE to start first-in-human study for artificial heart
BTAH, designed for patients with severe biventricular heart failure, uses rotary blood pump technology. Image credit: Shutterstock/Jolygon. 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 an early feasibility study in patients for the first time. The first-in-human study will […]
MSD reinforces Amazon partnership for faster AI-led drug discovery and development
As part of the multi-year cloud migration, MSD has been transitioning IT applications such as machine learning software and data warehouses to AWS. Image credit: Shutterstock/JLStock. Merck & Co (MSD) is continuing its multi-year cloud migration to Amazon’s cloud computing subsidiary Amazon Web Services (AWS), as the pharma company looks to accelerate scientific research and […]
Modus X robotic exoscope breaks into Europe
Currently Synaptive Medical operates in 15 countries and is operational in 80 hospitals worldwide. Credit: Synaptive Medical. Canada-based medical device company Synaptive Medical has revealed its Modus X robotic exoscope, a high-definition digital imaging system to the European market. The device, which assists surgeons in assessing magnified, 3D images during microsurgeries, will first be installed […]
FDA urged to drop proposed rule change for Laboratory Developed Tests
The FDA has said that it is intent on further regulating LDTs by updating the Medical Device Amendments ruling of 1976. Credit: Shutterstock / monticello The Utah University-based ARUP Laboratories is calling on the US Food and Drug Administration (FDA) to reverse its decision to regulate Laboratory-Developed Tests (LDTs) as medical devices. Previously, the FDA […]
Dimension Inx treats first patients with 3D regenerative bone graft
Bone grafts are used to repair and rebuild diseased or damaged bones. Credit: Morsa Images via Getty Images. Chicago-based regenerative therapeutics firm Dimension Inx has successfully implanted its CMFlex material in multiple patients. The 3D-printed regenerative bone graft product, is designed for maxillofacial, mandibular, and dental bone defects, and is manufactured using Illinois-based Desktop Health’s […]
Thermo Fisher and Flagship Pioneering partner to establish platform companies
In October 2023, Thermo Fisher reported a 1% decrease in revenue in Q3 FY 2023 to $10.57bn, compared to $10.68bn in the same period last year. Credit: Jonathan Weiss/Shutterstock. Thermo Fisher has announced a new partnership with biotechnology company Flagship Pioneering to establish a string of platform companies. The platform companies will focus on novel […]