Atricure Inc. has received the green light from the FDA for its Epi-Sense guided coagulation system with Visitrax technology to treat patients diagnosed with long-standing, persistent atrial fibrillation (AF). The device was previously cleared via a 510(k) for the coagulation of cardiac tissue, and is already available in the U.S. The FDA approval represents the first and only minimally invasive ablation therapy for the more than 3 million Americans with longstanding AF. Read More
PERTH, Australia – After gaining European clearance for its Eugeni COVID-19 rapid antigen test, Anteotech Ltd. reported a A$12 million (US$9.3 million) capital raise to launch its first global product that will help screen travelers, making it easier and safer to open borders. The Brisbane, Australia-based company was largely unheard of before the COVID-19 pandemic hit, but it has emerged as one of the few companies that has developed a low-cost, high sensitivity rapid COVID-19 test. Read More
TORONTO – Opsens Inc. has inked an agreement with Madrid, Spain’s Cathmedical Cardiovascular SA to integrate its coronary physiology algorithms with the Spanish firm’s next generation hemodynamic system, notably Opsens’ diastolic pressure ratio (DPR) for measuring diastolic heart pressure. Read More
Just four months after Blue Water Acquisition Corp. raised $50 million in an IPO, it set out on April 27 to merge with Clarus Therapeutics Inc., the developer of testosterone replacement therapy Jatenzo, valuing the Northbrook, Ill.-based firm at $379 million. Earlier in April, BCTG Acquisition Corp. announced plans to buy Cambridge, Mass.-based targeted precision cancer company Tango Therapeutics Inc. for $353 million, about seven months after completing its $167 million IPO. Both Clarus and Tango are seeking the public markets by merging with a special purpose acquisition company, or SPAC, a method that is becoming increasingly popular and an alternative to the traditional IPO. Read More
HONG KONG – Shionogi & Co. Ltd. has inked a multitarget drug discovery collaboration for Inveniai LLC’s artificial intelligence and machine learning platform Alphameld. Inveniai is eligible to receive up to $200 million per program through a combination of up-front payments, development and commercial milestones, and royalties. Read More
Med-tech firms raising money in public or private financings, including: Artio Medical, Aveanna, Grin, Microbix Biosystems, Microsure, Replicel, Sera Prognostics, The Public Health Company. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abiomed, Aziyo Biologics, Becton Dickinson, Daxor, Gatt Technologies. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Human Imaging, Align Technology, Amgen, Canon Medical, CCRM, Halma, Illumina, Intuitive Surgical, Linshom, Oxford Immunotec, Perigen, Physimax, TÜV SÜV, Valted Seq. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Atricure, Cerapedics, Celltrion, Lumenis, Soliton, Sommetrics. Read More
Keeping you up to date on recent developments in diagnostics, including: Urine test could reduce prostate cancer biopsies; Neurons forget who they are in Alzheimer’s disease; Sensor can predict hallucinogenic serotonin receptor effects. Read More