Andera Partners and Novo Holdings A/S led a financing round which raised $25 million for Fire1 Ltd. and will accelerate the development of the company’s remote monitoring technology that improves outcomes for heart failure patients. Andera and Novo are new investors in Fire1 and were joined in the fundraising round by existing investors Gilde Healthcare, Gimv, the Ireland Strategic Investment Fund, Lightstone Ventures, Medtronic plc, New Enterprise Associates and Seventure Partners.
Johnson & Johnson’s Biosense Webster division reported that its Qdot Micro diagnostic and ablation deflectable tip catheter secured approval for marketing in China from the National Medical Products Administration where options for treating arrhythmias are seeing growing demand. A radiofrequency (RF) ablation catheter, Qdot Micro reduced total ablation procedure time by nearly 90 minutes.
Methinks Software SL (dba Methinks.AI), a digital health company, is working on the U.S. FDA submission for its artificial intelligence (AI)-based stroke triage software, which will aid in the detection of acute stroke, after recently receiving CE mark certification.
Cardio Diagnostics Holding Inc. launched Precisionchd, a blood test for the early detection of coronary heart disease. The test will initially be available for existing customers, with nationwide rollout to follow shortly thereafter, the company said.
Eko Devices Inc. launched a new platform designed to easily identify heart and vascular problems. The artificial intelligence (AI)-driven Sensora cardiac disease detection platform currently features an algorithm that detects structural murmurs and another to guide patient care through the health care system.
Ra Medical Systems Inc. launched a simple device that holds sutures more securely in place for closure of percutaneous wound sites during cardiac electrophysiology, structural heart and vascular surgical procedures.
Medtronic plc recently received the CE mark for its Aurora extravascular implantable cardioverter-defibrillator (EV-ICD) strengthening its cardiovascular portfolio which saw a 7% year-on-year growth in the third quarter of its fiscal year 2023.
Xeltis BV has completed a €32 million (US$34 million) series D2 round that will propel the clinical development of its electrospun polymer implants across several indications. The fully synthetic implants promise the best of both worlds, with the mechanical strength required to be fully functional from day one, and bioresorbable properties that cause gradual degradation as endogenous tissue regenerates to form a natural replacement.
Cardiorenal Systems Inc. has scored a U.S. FDA breakthrough device designation for technology to prevent patients undergoing cardiac surgery from developing acute kidney injury (AKI). AKI is reported in up to 30% of approximately 780,000 cardiac surgeries performed each year in the U.S., Europe and the Middle East, complicating patient recovery, prolonging ICU hospitalization and contributing to patient mortality after surgery.