Industry News
The latest medical device regulatory news, clinical trials, and market insights
Understanding Medical Device Recalls: What Healthcare Professionals Need to Know
Medical device recalls are critical actions taken to address potential safety or regulatory violations associated with a device. Recently, updates…
Scemblix® Gains Extended Therapeutic Indication Approval from Swissmedic
Swissmedic has officially announced an extension of the therapeutic indications for Scemblix®, a drug that plays a pivotal role in…
Regulatory Alert: Patient Information Leaflet Defect for Hikma Farmacêutica’s Gemcitabine 2g/52.6ml Infusion Concentrate
On September 30, 2025, Hikma Farmacêutica (Portugal) S.A issued a notification to the Medicines and Healthcare products Regulatory Agency (MHRA)…
Critical FDA Update: BD Expands Class I Recall for Alaris™ Pump Infusion Sets
Meta Description: BD has expanded its voluntary Class I recall for Alaris™ Pump infusion sets, adding 15 discontinued models with…
FDA Lifts REMS for Caprelsa (vandetanib), Signaling New Safety Confidence
The U.S. Food and Drug Administration (FDA) has announced the removal of Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa…
Regulatory Update: Swissmedic Confirms Safety of Paracetamol Use During Pregnancy
Swissmedic, Switzerland’s regulatory authority for therapeutic products, has reaffirmed its position on the use of medicines containing paracetamol during pregnancy.…
Critical Updates: Field Safety Notices Issued from 8–12 September 2025
Important updates for clinical, quality, and regulatory teams: A series of Field Safety Notices (FSNs) were published between 8 and…
FDA Clears Innovative Essilor Stellest Eyeglass Lenses to Manage Pediatric Myopia Progression
The U.S. Food and Drug Administration (FDA) announced on September 29, 2025, the authorization of Essilor Stellest eyeglass lenses. This…
Olympus Recalls Specific ViziShot 2 FLEX Needles Due to Safety Concerns
Olympus Corporation has announced a voluntary global recall of certain lots of its ViziShot 2 FLEX (19G) EBUS-TBNA needles. The…
FDA Approves First Pediatric Eyeglass Lenses to Mitigate Myopia Progression
The U.S. Food and Drug Administration (FDA) has authorized the marketing of Essilor Stellest eyeglass lenses. This marks the first…
Swissmedic Grants Initial Authorisation for VANFLYTA®: Impact on Clinical and Regulatory Practices
Swissmedic has officially authorised VANFLYTA®, marking its initial regulatory approval. This announcement, dated September 30, 2025, highlights a significant development…
Critical Updates: Field Safety Notices Issued for Medical Devices (15–19 September 2025)
Healthcare professionals and regulatory teams, please take note. Between 15 and 19 September 2025, a range of Field Safety Notices…