Cresilon Inc. obtained U.S. FDA clearance for a hemostatic gel that staunches the flow of blood from minor external wounds. The Cresilon hemostatic gel (CHG) is the first technology to blend polymers from the algae plant to instantaneously create a mechanical barrier against bleeding.
Awak Technologies Pte Ltd. and Singapore General Hospital (SGH) plan to launch a pre-pivotal clinical trial for their automated wearable artificial kidney peritoneal dialysis (Awak PD) device. Awak PD is a wearable and portable PD device designed for patients with end-stage kidney disease to have dialysis on the go. The research team is now recruiting subjects for the single-site, prospective, single-arm study.
The U.S. CMS is proposing to expand coverage of angioplasty and stenting for the carotid arteries to include patients who currently cannot receive this treatment for carotid artery stenosis outside of a clinical trial, generally a cause for celebration among device makers. However, Silk Road Medical Inc. is one possible exception to the overall picture as utilization of its transcarotid artery revascularization (TCAR) system may suffer as a result.
Sonio SAS closed its series A fundraising round raising $14 million that will go some way in helping the company deliver on its mission to improve access to quality pregnancy monitoring for women everywhere through its software-as-a-service (SaaS) platform. Sonio has developed an artificial intelligence (AI) prenatal screening solution that automates ultrasound reporting while providing image quality control and detection of potential anomalies. The capital raise was led by Cross-Border Impact Ventures, a North American impact fund dedicated to the health of women and children.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allosource, Boston Scientific, Invictus Medical, Teijin Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amplified Sciences, AstraZeneca, Caristo Diagnostics, Neurometrix, Ophthalmic Surgical Solutions, Tempus Labs, Vantage Surgical Solutions, Verve Medical.
Nuclidium AG, an early stage radiopharmaceuticals and radiodiagnostics developer, aims to bypass the production constraints that have hampered other firms in the field by employing copper radioisotopes for both therapeutic and imaging purposes.
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