New hires and promotions in the med-tech industry, including: Acutus Medical, Axogen, Deep 6 AI, Deepcell, Egenesis, Glaukos, Medx Health, Novan, Philips, Picnichealth, Pieriandx.
Non-clinical testing for the SARS-CoV-2 virus has been a major goal for regulators across the globe for months. Emergency use authorization (EUA) was just granted by the FDA is for the Quidel Quickvue COVID-19 test, an at-home antigen test with a turnaround time of 10 minutes. It’s the latest in a series of approvals of home tests and collection kits that promises to help control the pandemic.
Rebus Biosystems Inc. introduced the first commercially available spatial omics platform at the Advances in Genome Biology and Technology virtual meeting on March 1. The Rebus Esper builds on the company’s Synthetic Aperture Optics (SAO) technology that enables rapid quantitative analysis of tens of millions of cellular features across hundreds of thousands of cells in their native tissue contexts.
PARIS – Less than a year after its formation, Acusurgical SAS, has secured a $7 million series A round to develop its robotic platform for assisting surgeons performing microsurgery procedures in retinal surgery. “Our goal isn’t to replace the surgeon but to increase his surgical capacities. Our mission is to create an augmented surgeon,” Christoph Spuhler, CEO and co-founder of Montpellier, France-based Acusurgical, told BioWorld.
Hologic Inc. continues to strengthen its diagnostics businesses via tuck-ins, this time with the acquisition of Diagenode SA for $159 million. The Belgium-based developer of molecular assays and epigenetics products counts more than 30 real-time polymerase chain reaction (PCR) tests in its portfolio. Marlborough, Mass.-based Hologic has been on a spending spree in recent months. In January, the company completed the acquisition of Somatex Medical Technologies GmbH for about $64 million and agreed to buy molecular diagnostics company Biotheranostics Inc. for $230 million.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CRS: Supply chain for testing still under pressure; AHRQ eyes provider-to-provider telehealth; Health Canada emphasizes nursing homes in report on testing; Advamed, Georgia Bio sound off on EtO.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clinical Enterprise, Fluidigm, Invo Bioscience, Memic Innovative Surgery, Mobidiag, Opgen, Perimeter Medical Imaging AI, Vascular Grafts Solutions, Vetex Medical.