Hologic Inc., which focuses on women’s health, said Jan. 4 that it has completed the acquisition of Somatex Medical Technologies GmbH for roughly $64 million. Based in Berlin, Somatex focuses on minimally invasive devices for tumor diagnostics, biopsy and interventional specialties. Somatex’s portfolio includes biopsy site markers and localization technologies, including Trumark markers. The company was previously owned by E-Med Solutions GmbH, a group of investors led by German private equity firm Westlake Partners. Read More
Flowonix Medical Inc. and Swk Holdings Corp. closed a $33 million financing that included $10 million in debt facility from Swk in addition to $23 million in a series B round led by returning investor Farallon Capital Management with support from several new investors. The financing will replace approximately $7.5 million in prior venture debt from Hercules Capital. It will also fund development of new products, entry into new disease markets, production expansion, and partnerships with pharmaceutical companies. Read More
The U.S. FDA’s device center may still be grappling with the COVID-19 pandemic throughout the remainder of fiscal year 2021, but that does not mean other considerations have disappeared. The FDA’s Erin Keith said the agency will keep working on a major overhaul of the quality systems regulation (QSR) but will also work toward expanding industry’s use of advanced manufacturing technologies, such as additive manufacturing. Read More
PARIS – Solvay SA is partnering with Printerprezz Inc. to develop 3D printing technology using Selective Laser Sintering (SLS) for implants and other medical devices. Read More
HONG KONG – Votis Subdermal Imaging Technologies Ltd. is developing a diagnostics solution that could prevent the loss of feet among India’s impoverished due to affects of peripheral artery disease (PAD). The company has entered an agreement with India’s Ii Ventures Pte. Ltd. (iiV) to develop a system to screen the largely rural Indian population for PAD. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allscripts, Aposhealth, Caredx, Casa Schmidt, Centene, Henry Schein, Integra Lifesciences, Magellan Health, Nextgen Biomed, Scent Medical Technologies, Si-Bone, Smith & Nephew, Virtue Health, Wellsky. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Atricure. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA: Curative test for COVID should be conducted per product label; FDA posts MEA final guidance; CMS eyes radiology quality measures; Ra Medical agrees to fines. Read More
Keeping you up to date on recent developments in cardiology, including: Researchers outline new stroke strategy; Group assesses role of neutrophil extracellular traps in coronary thrombosis in COVID-19 patients; Link identified between metabolic syndrome and higher cardiovascular risk in patients with psoriasis. Read More
