Japan Recommends Global-First Conditional Approvals Of Two iPSC Therapies
Japan has granted the first positive approval recommendations worldwide for two allogenic cell therapies derived from induced pluripotent stem cells, Sumitomo’s raguneprocel for Parkinson’s and Cuorips’ cardiomyocyte patches for heart failure.
Scrip - February 20, 2026

Radiologist Abramson Takes The Reins At Digital Health Center of Excellence
The US FDA has a new digital health head in radiologist Rick Abramson, an AI-industry veteran who is now director of the Digital Health Center of Excellence. Abramson has been an FDA adviser since last summer.
Medtech Insight - February 19, 2026

Class I Recalls Rose In 2025, Despite Drop In Overall Number
Class I medical device recalls reached record-breaking levels in 2025, according Sedwick’s annual product safety report, with device failure the leading cause.
Medtech Insight - February 19, 2026

Olympus To Cut 2,000 Jobs, Revises Guidance As FDA Inspections Weigh On Q3
Olympus released its Q3 2025 earnings on Feb. 13, lowering its full-year revenue outlook by 2% on a constant currency basis. While the company acknowledged continued pressure in the US, management said it expects performance to rebound in Q4.
Medtech Insight - February 19, 2026

Medtronic Wins FDA Clearance For Stealth AXiS, Targets Spine Robotics Growth
The Stealth AXiS system is designed as an integrated platform that combines robotics, surgical planning and navigation into a single solution for spine procedures.
Medtech Insight - February 19, 2026

Telehealth Company Hims & Hers To Acquire Eucalyptus In A Deal Up To $1.15Bn
Hims&Hers announced plans to acquire digital health company Eucalyptus for up to $1.15bn.
Medtech Insight - February 19, 2026

Execs On The Move: February 9–13, 2026
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
Medtech Insight - February 19, 2026

UK Industry Fires Warning Shots Over Cost Burden, Support Levels And Over-Regulation In Market
The latest annual UK ABHI survey of medtech industry sentiment on market access, regulatory hurdles and pathways for innovation reveals polarized views and levels of frustration among manufacturers who face ever higher compliance workloads.
Medtech Insight - February 19, 2026

US FDA’s Push For Greater Transparency: What About Advisory Committees?
Posting action packages for rejected products, not just the complete response letters, is a provocative idea, but also a reminder of what the FDA has lost by not holding many advisory committees during the Trump Administration.
HBW Insight - February 20, 2026

Regulatory Recap: India Boosts Biosimilar Development With A $1bn Investment
Generics Bulletin reviews global regulatory developments across the world.
Generics Bulletin - February 19, 2026

Latest FDA Biosimilar Nod Pushes Accord Towards 2030 Target
Accord Biopharma’s US FDA approval for a filgrastim biosimilar rival to Neupogen takes it a step closer to realizing its ambition of launching 20 biosimilars by 2030.
Generics Bulletin - February 19, 2026

Can Outlook Break The Cycle With Fresh FDA Meeting On Ophthalmic Bevacizumab?
After multiple knockbacks from the US FDA over its Lytenava ophthalmic formulation of bevacizumab, Outlook Therapeutics is hoping to resolve issues with the agency. It said the latest complete response letter was “inconsistent” with the BLA's evidence and “unexpected” after earlier FDA advice.
Generics Bulletin - February 19, 2026

Burn Control And Subcutaneous Focus: OSE’s Bid To Reprice Its Science
When OSE Immunotherapeutics' board ousted CEO Nicolas Poirier in October 2025, it handed his successor a clear mandate: spend less, partner sooner and stop asking shareholders to wait.
In Vivo - February 19, 2026