Signum Surgical

On behalf of Signum Surgical, we sincerely thank Dorothy Abel and the team at Abel & Wolf Consulting (abelandwolf.com) for their guidance, professionalism and commitment throughout our recent FDA De Novo application for BioHealx. Their support proved pivotal in navigating the process and securing a successful FDA De Novo application. BioHealx is now classified by the FDA as a first of its kind medical device for the treatment of anal fistula, a key milestone for our company, which paves the way for the future commercialisation of BioHealx in the US. #MedTech #BioHealx #HealthcareInnovation #BioInnovate #SignumSurgical #FDA

Today we are delighted to announce that BioHealx has been granted marketing clearance by the U.S. Food and Drug Administration (FDA), as a first-of-its-kind medical device for the treatment of anal fistula. De Novo classification and clearance by the FDA is a key milestone for Signum Surgical and paves the way for bringing BioHealx to market for the benefit of patients, surgeons and the overall healthcare system.   To view the full press release, please visit: https://lnkd.in/eW2G3g2C   #MedTech #BioHealx #HealthcareInnovation #BioInnovate #SignumSurgical #FDA

We are delighted to be attending JPMorgan Chase & Co.’s Annual Healthcare Conference 2024 in San Francisco this week. This important event connects industry leaders, emerging fast-growth companies, medical technology innovators, and the global investment community. With our clinical trial for BioHealx completed, 2024 promises to be an exciting year. We look forward to meeting fellow participants and investors this week and introducing them to our business and our innovative BioHealx technology.   Eoin Bambury Moshe Zilversmit #jpm2024 #MedTechInnovation #InvestmentOpportunities #TeamIreland #SanFranciscoNetworking #HealthcareInnovation #MedTech #IrishMedTech #BioInnovateIreland

This week, our co-founder Moshe Zilversmit had the privilege of touring some of the leading healthcare systems in the Northeast US. The market study, organised by Enterprise Ireland visited Mass General Brigham, Hackensack Meridian Health, and Northwell Health, and provided a brilliant opportunity for us to discuss our innovative #BioHealx technology with key medical executives, clinicians, and other med-tech companies in attendance. Special thanks to Selma Brennan, Jennie Lynch, David Corcoran and Tomás Scully in Enterprise Ireland for organizing a super event and to our hosts in Mass General Brigham Hackensack Meridian Health, and Northwell Health. Bluedrop Medical FoodMarble Head Diagnostics Gasgon Medical Salaso MEG | Healthcare Quality Management Software Nova Leah Novus Diagnostics NUA SURGICAL Ostoform Ltd RelateCare | Care is in our name SureWash #MedTech #HealthTech #IrishMedTech #Innovation

We were delighted to have attended the American College of Surgeons which took place from 22-25 October in Boston, MA. The event offered us the opportunity to engage with experts and professionals in the surgical field to discuss groundbreaking medical advances in procedures, the latest research, and to network with peers from around the world. We also had the chance to introduce and discuss our #BioHealx device, a minimally invasive technology for treating anal fistulas, with surgeons and colorectal experts. Thanks for having us  American College of Surgeons and hope to see you again next year! Moshe Zilversmit Eoin Bambury #ACSCC23 #MedTech #SignumSurgical #BioHealx