Posted inMedical Device
Indian Medical Device Regulation Faces Tough Stent Test
Indian medical device regulation faces a test as the Health Ministry is asked to examine stent safety. How oversight works and what reforms are floated.
Posted inMedical Device
Sensydia Raises Over $6 Million to Advance Noninvasive Cardiac Monitoring Device Toward FDA Review
Sensydia cardiac monitoring funding: over $6M led by Colle Capital to take its noninvasive CPS through ACOUSTIC-1. It is not yet FDA authorised.
Posted inMedical Device
FDA Clears Providence Medical Technology 3D-Printed Titanium Implant for Cervical Spine Fusion
CORUS PCSS 3D-T FDA clearance adds a porous titanium lattice to a cervical fusion system. No clinical data for the new version have been reported.
Posted inMedical Device
Butterfly Medical Secures EU Certification for Enlarged Prostate Treatment Device
Butterfly Medical prostate device EU approval: the BPH implant gains EU MDR certification. A 244-patient trial is complete; no US approval yet.
Posted inMedical Device
European PULSE Trial to Test Repeat OncoSil Implants in Pancreatic Cancer
OncoSil joins the EU-backed PALACROS programme via the PULSE Phase 2 trial: 120 patients, five centres, single versus repeat implants. No results yet.
Posted inMedical Device
QIAGEN Expands QIAstat-Dx Bloodstream Infection Testing in the US With New Gram-Negative Panel
QIAstat-Dx bloodstream infection portfolio is complete in the US as QIAGEN wins FDA clearance for a gram-negative panel with 18 resistance markers.
Posted inMedical Device
AI-Powered Surgical Software Market to Reach $24.55 Billion by 2035 at 30.2% CAGR
The AI-powered surgical software market is forecast to grow from $1.75B in 2025 to $24.55B by 2035 at a 30.2% CAGR, per Acumen Research.
Posted inMedical Device
UK Introduces Continuous Monitoring Framework for AI Medical Devices in Major Regulatory Shift
The UK accepts all 44 recommendations on AI regulation, moving to lifecycle monitoring of AI medical devices. What the MHRA plans, and when.
Posted inMedical Device
Healthium, Romsons in Race to Acquire 70–80% Stake in BL Lifesciences at Up to ₹2,000 Crore Valuation
Healthium and Romsons are reported to be bidding for a 70-80% stake in BL Lifesciences at a valuation of up to Rs 2,000 crore. What is known so far.
Posted inMedical Device
GE HealthCare to Acquire SOFIE Biosciences for $945 Million in Major Radiopharma Expansion
GE HealthCare will buy SOFIE Biosciences for $945 million in cash, adding 15 PET radiopharmaceutical sites and 21 cyclotrons. Close expected in H1 2027.