Ossdsign AB will abandon its 3D-printed cranial reconstructive implant business to focus on U.S. sales of its Ossdsign Catalyst, an off-the-shelf nanosynthetic bone graft that offers gross margins of 90% or better. The new strategy sharply reduces the capital required before the company projects achieving a cash-flow positive position.
The U.S. FDA recently convened an advisory hearing to discuss whether three in vitro diagnostics should be reclassified from class III to class II, including tests for the pathogens responsible for Hepatitis B and tuberculosis. The panel agreed that all three of the test types should be reshuffled to the lower-risk class II category, suggesting that test developers now have an opportunity to jump into a market with lower-cost tests that won’t need expensive and drawn-out clinical studies to obtain the FDA’s seal of approval.
Proteomics International Pty Ltd has developed a new blood-based diagnostic test called the Promarkereso that identifies patients with esophageal adenocarcinoma as well as patients with a pre-malignant condition called Barrett’s esophagus that can arise from chronic acid reflux.
Artificial intelligence (AI) is an increasingly common matter of medical practice and thus not just another buzzword, and the U.K. National Institute for Health and Care Excellence (NICE) has opened a program for evidence generation for the use of AI to contour external beam radiotherapy to the tumor of treatment.
The co-founder and CEO of Total Flow Medical Ltd, Hilary Pierce, reported the filing of a patent for bidirectional flow cannulas configured and designed to replace conventional femoral arterial cannulas for extracorporeal circulation during cardiopulmonary bypass procedures and that provide an optional dedicated blood flow to the ipsilateral limb.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aspekt Solutions, Everads Therapy, Femasys, Kriya Therapeutics, Nanovibronix, Onward Medical, Siemens Healthineers, Signati, Varian.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Laminate Medical Tecnologies.
Zig Therapeutics Inc. reported on new patented systems and methods for the remote diagnosis and treatment of a bacterial infection in individuals with chronic respiratory diseases experiencing acute respiratory exacerbations using automated color vision sputum analysis.
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