Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neoteryx, Smith & Nephew.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accelerate Diagnostics, B Dot, Biosynex, Biotronik, Centinel Spine, Curebase, Diagnostic International, Eurobio Scientific, Gore, Labcorp, Movano, Procisedx, Raysearch.
In the first five months of 2023, med-tech deal value is at the highest amount in recent years – up 128.219% from last year – while deal volume has decreased by 12.29%. Through May this year, 742 med-tech deals have raised a potential $5.38 billion, compared to 846 deals totalling $2.36 billion last year. The two recent years are vastly more than 2021, when through May there were 661 deals raising $386.69 million.
U.S. federal authorities continue to wrap up cases in connection with COVID fraud, the latest of which yielded a $30 million fine for a single defendant accused of fraud and money laundering.
The need to reauthorize the U.S. Pandemic and All-Hazards Preparedness Act (PAHPA) prompted a June 13 hearing in the House of Representatives, but a major fissure appeared between the Republican and Democratic Parties regarding FDA’s authorities for managing drug shortages.
Cardiorenal SAS reported it has been granted a breakthrough device designation by the U.S. FDA for its Tenor at-home blood potassium measuring device. The Tenor smart device combines multiple technologies, app and cloud capabilities to assist patients with chronic kidney disease in measuring their blood potassium levels from home, obtaining results in under five minutes.
Vivolta BV raised €7 million ($US7.56 million) in new financing from existing shareholders and the Dutch government to expand its Medispin platform, an automated medical electrospinning production system, for high-throughput manufacturing of tubular electrospun products such as vascular stent grafts and prosthetic heart valves. The funds will also allow the company to continue to evolve into a medical electrospinning contract development and manufacturing organization as it transitions away from an equipment manufacturer.
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