Merit Medical Removes Dialysis Catheter Introducer in FDA Class I Recall
Merit Medical announced a Class I FDA recall of its 16F Dual‑Valved Splittable Sheath Introducer, a component used in several dialysis catheter kits. The sheath may fail to split during catheter placement, potentially causing hemorrhage, embolization, thrombosis, or loss of future vascular access. Merit has instructed customers to stop using the introducer, label affected kits and destroy the component, while allowing other kit elements to remain in service. As of Feb. 23, two serious injuries have been reported, but no deaths are linked to the defect.
Why Attend the Toronto Life Sciences and Biotech Summit 2026
The Toronto Life Sciences and Biotech Summit on May 7, 2026 will convene real‑estate developers, biotech executives and ecosystem partners to address funding constraints, talent dynamics, and evolving lab‑space demand in the Greater Toronto Area. Speakers will explore how slower...
Off the Shelf Cell Therapies for Bone Marrow Transplantation with Ossium Health’s Kevin Caldwell — Episode 251
In episode 251 of the Xtalks Life Science Podcast, Kevin Caldwell, CEO and co‑founder of Ossium Health, discusses the company’s pioneering off‑the‑shelf bone‑marrow therapy derived from deceased organ donors. The treatment aims to solve long‑standing clinical and logistical hurdles in...
Top 20 Most Innovative Healthcare Companies in 2026, Per Fast Company
Fast Company’s 2026 list spotlights the 20 most innovative healthcare firms, ranging from biotech pioneers like Children’s Hospital of Philadelphia’s CRISPR therapy to digital‑health platforms such as Lantern and Maven Clinic. The rankings arrive amid a surge in drug approvals—46...
Novartis Slashes 114 More Jobs at New Jersey HQ
Novartis announced a second wave of US layoffs, eliminating 114 positions at its East Hanover, New Jersey headquarters. The cuts are part of a multi‑year restructuring that follows the spin‑off of its generics arm Sandoz and earlier reductions in medical...
Spinal Elements Wins FDA Clearance for Ventana A ALIF System, Expands 3D-Printed Spine Portfolio
Spinal Elements has secured FDA 510(k) clearance for its Ventana A anterior lumbar interbody fusion (ALIF) system, the latest addition to its 3D‑printed titanium spine portfolio. The company reports that the first U.S. cases have already been completed, demonstrating early...
World Hemophilia Day 2026: New Treatment Era and Improving Diagnosis
World Hemophilia Day on April 17, 2026 spotlighted the urgent need to improve diagnosis of hemophilia and related bleeding disorders, with the World Federation of Hemophilia (WFH) estimating that more than three‑quarters of patients remain undiagnosed. The theme underscored a...
Zeto New Wave EEG System Wins FDA Clearance For At-Home Brain Monitoring
Zeto announced FDA 510(k) clearance for its New Wave EEG system, the company’s third FDA‑approved neuro‑diagnostic platform. The device is a 21‑electrode, gel‑free headset designed for short‑term, up‑to‑2.5‑hour recordings in outpatient clinics and patients’ homes. Integrated with Zeto’s cloud and...
FDA Clears Low-Dose MRI Contrast Agent Vueway for Newborns and Infants
The U.S. Food and Drug Administration has granted an expanded indication for Bracco's Vueway (gadopiclenol) injection, allowing its use in neonates and infants for contrast‑enhanced MRI. The macrocyclic agent delivers high‑quality images at half the standard gadolinium dose (0.05 mmol/kg), addressing...
Baebies’ Finder Platform Secures Dual FDA Clearance and CLIA Waiver
Baebies announced that its Finder platform has received FDA 510(k) clearance for a Flu A&B/SARS‑CoV‑2 test and a CLIA waiver, making it the first molecular point‑of‑care system with multifunctional capabilities. The cartridge‑based device delivers PCR‑quality results in 15‑20 minutes, enabling...
Parkinson’s Awareness Month and World Parkinson’s Day 2026: Advocacy and Therapeutic Progress
April marks Parkinson’s Awareness Month, culminating in World Parkinson’s Day on April 11, which unites patients, clinicians and advocates worldwide. The disease now affects roughly 11.8 million people and could rise to 25 million by 2050, making early recognition critical. Recent therapeutic advances...
Lynavoy (Linerixibat) Wins FDA Approval for Rare Liver Disease After Alfasigma-GSK Licensing Deal
Alfasigma secured FDA approval for Lynavoy (linerixibat), the first U.S. therapy specifically indicated for cholestatic pruritus in primary biliary cholangitis (PBC). The approval follows a March licensing agreement with GSK that could be worth up to $690 million, including a $300 million...
Scalable Biologics Production Trends: Featuring Omar Wahab of Lonza — Breakthrough, Episode 250
In episode 250 of the Xtalks Life Science Podcast, Lonza’s Vice President of Bioprocessing Omar Wahab explains why cell‑culture media is a strategic lever for scalable biologics manufacturing. He argues that early formulation choices influence downstream productivity, product quality, and...
Yuviwel Gets FDA Greenlight as First Once‑Weekly Treatment for Dwarfism in Children
Ascendis Pharma’s Yuviwel (navepegritide) received FDA approval as the first once‑weekly therapy for achondroplasia in children aged two and older. The drug, a TransCon CNP formulation, showed a 1.5 cm greater annual height gain versus placebo in a 52‑week trial and...
CSL Plans $1.5B Expansion of Illinois Plasma Therapy Manufacturing Facility
CSL announced a $1.5 billion expansion of its plasma‑therapy manufacturing plant in Kankakee, Illinois, aimed at boosting output of immunoglobulins, albumin and specialty proteins. The project will add at least 300 jobs to the existing 1,200‑person workforce and is expected to...
