Axogen Seeks FDA Approval For Avance Nerve Graft

Supported by results from the RECON trial, the Florida company will file a biologics license application for its Avance nerve graft used surgical repair of finger injuries

Avance Nerve Graft Circle
AXOGEN'S AVANCE NERVE GRAFT • Source: Axogen Inc.

Axogen is on track to seek US Food and Drug Administration approval for its Avance nerve graft device by the end of next year.

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Abbott’s TriClip Reduces Severity Of Tricuspid Regurgitation Two-Year Results Confirm

 

Abbott presented late-breaking data at the 2025 American College of Cardiology conference demonstrating that TriClip transcatheter edge-to-edge repair offers prolonged patient benefits compared to medical treatment alone after two years, which were not evident at one year.

Exact Sciences Launches Cologuard Plus

 

The Cologuard Plus test has a sensitivity of 95% and a specificity of 94% for the detection of colorectal cancer; “unmatched accuracy,” according to Exact Sciences.

LSI 2025: Vektor Medical CEO Says ‘Arrhythmia Is The Biggest Health Care Crisis Nobody Talks About,’ vMap Treats It With 91.1% Accuracy

 
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Vektor Medical is ramping up efforts to bring its vMap technology used to identify arrhythmia sources to more US hospitals, start enrollment in a multinational trial, and commercialize in Europe, pending the CE mark. Medtech Insight sat down with CEO Rob Krummen at LSI 2025 to discuss their plans.

Owlstone Medical Develops P.aeruginosa Breath Test For Cystic Fibrosis Patients

 

Cambridge, UK-based breath biopsy company Owlstone Medical will apply its volatile organic compound analysis platform in an attempt to develop a test for the identification and monitoring of pseudomonas aeruginosa in patients with cystic fibrosis.

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Owlstone Medical Develops P.aeruginosa Breath Test For Cystic Fibrosis Patients

 

Cambridge, UK-based breath biopsy company Owlstone Medical will apply its volatile organic compound analysis platform in an attempt to develop a test for the identification and monitoring of pseudomonas aeruginosa in patients with cystic fibrosis.

Urine Test Could Halve Number Of CT Scans For Patients With Kidney Cancer

 

The urine-based GAGome test showed promise in the first clinical results from the international AURORAX-0087A, in the largest study conducted on clear cell renal cell carcinoma, the most common type of kidney cancer.

23andMe Files For Bankruptcy, Raising Fresh Concerns Over Fate Of Genetic Data

23andMe has filed for Chapter 11 bankruptcy and announced the resignation of founder and CEO Anne Wojcicki. Privacy concerns surrounding the sale of its extensive genetic database remain after a 2023 data breach exposed data from some 7 million users. Experts warn that bankruptcy proceedings could lead to consumer data being sold, raising questions about legal protections and consumer rights.