Medical Design and Outsourcing10d
A surgical robotics co-founder offers lessons from the de novo pathway
After winning FDA authorization for CMR's Versius, Slack offered advice for navigating the de novo pathway and new ...
FDA grants accelerated approval to Jazz Pharmaceuticals’ Ziihera
The Food and Drug Administration granted accelerated approval to zanidatamab-hrii, or Ziihera from Jazz Pharmaceuticals (JAZZ), Inc., a ...
From Pills To Devices: How Pharma Is Expanding Into The Medical Device Market
Though the strategic shift allows pharma to offer integrated health solutions, diversify revenue and improve patient outcomes ...
360dx11d
'On Vivo' and 'In Vivo' Wearable Diagnostics Advancing to Clinical Use
Wearable diagnostics are poised to transform subjective, episodic measures of disease progression to quantified, continuous ...
How strong regulations on implantable devices can shape new innovation
Robust regulations on implantable devices safeguard both patients and manufacturers but can also drive innovation.
Loughborough University10d
World-class ‘accelerator’ to speed development of crucial rehabilitation technologies
A world-class impact accelerator will connect hundreds of East Midlands MedTech SMEs with health and care professionals, ...
Rznomics announces to secure the Expanded Access Program for patients with Glioblastoma (GBM)
Rznomics, Inc. announced to secure its expanded access program (EAP) from the United States Food and Drug Administration (FDA) for RZ-001, ...
medtechdive16d
FDA breakthrough device decisions rebound after recent declines
The FDA designated 166 products under its breakthrough devices program in its most recent financial year, reversing the ...
Spectral AI Raises Up to $5 Million Financing Strengthening Financial Position for FDA Pathway
Detailed price information for Spectral Ai Inc (MDAI-Q) from The Globe and Mail including charting and trades.
ZenGUARD(TM) Enhanced Air Filters to Be Added as Class 1 Medical Device Under Zentek's Medical Device Establishment Licence
Zentek's patented technology platform ZenGUARD™ is shown to have enhanced viral filtration efficiency for surgical masks and aims to do the same for HVAC (heating, ventilation, and air conditioning) ...
FDA Grants De Novo Authorization to OMRON Healthcare for New Blood Pressure Monitors with AI-Powered AFib Detection Feature
In a pivotal stride to address the growing AFib epidemic, OMRON Healthcare today announced the U.S. Food and Drug ...
IAS story: This village of 75 households is called UPSC ‘factory’ of due to.., it is located in…
Speaking of UPSC, do you know which village in India is known as the ‘UPSC Factory’? This small village has earned its ...