The European Medicines Agency (EMA) has launched a pilot program to fast track breakthrough medical devices in the EU and get lifesaving technologies to patients sooner. The program will allow for companies to obtain scientific advice from the expert panels intended to support evidence generation and clinical development of their devices.
Caredx Inc. has agreed to acquire Naveris Inc., a precision oncology diagnostics company, for up to $260 million, as part of its strategy to accelerate growth. The acquisition comes as Caredx, an organ transplant diagnostic firm, reshapes its portfolio, expanding its oncology profile while recently divesting its lab products business.
Nervonik Inc. raised $52.5 million in a series B financing round for its peripheral nerve stimulation (PNS) system designed to treat patients with chronic pain and other neurological conditions. The funds will be used to support the continued development Nervonik's PNS system, including enhancements to the system’s sensing capabilities, as well as preparations for commercialization.
Thermo Fisher Scientific Inc. agreed to sell its microbiology business to Astorg, a private equity firm, for approximately $1.075 billion, consisting of cash and a $50 million seller note. The business unit provides antimicrobial susceptibility testing and culture media solutions for clinical, pharmaceutical and food safety testing.
New data on pulsed field ablation (PFA) presented at Heart Rhythm 2026 in Chicago over the weekend continue to show the benefits and superiority of the technologies in treating patients with atrial fibrillation. The PFA landscape is fast-evolving and med-tech players are jostling for market share with ever-differentiated platforms looking to attract electrophysiologists.
Edwards Lifesciences Corp. raised its full-year 2026 guidance after seeing strong sales in the first quarter, particulalry from its transcatheter aortic valve replacement (TAVR) business. The company now expects sales growth of 9% to 11%, up from prior outlook of 8% to 10%, and adjusted earnings per share of $2.95 to $3.05, compared with earlier guidance of $2.90 to $3.05.
The first fully robot-assisted cataract surgery recently performed using Forsight Robotics Ltd.’s Jasper platform was not only a “transformative” event and a major “milestone” for the company, but also a “huge step forward for the industry,” Joseph Nathan, co-founder, president and chief medical officer, told BioWorld. With one in two people globally needing cataract surgery and unable to get access to care, robot-assisted platforms hold the potential to increase surgical throughput and broaden access to treatment.
Boston Scientific Corp.'s CEO Mike Mahoney said that the year is turning out to be “more challenging” than the company anticipated, prompting a cut to its organic sales growth guidance to 6.5% to 8%, from 10% to 11%. The company also lowered its adjusted earnings-per-share guidance to $3.34 to $3.41, from $3.43 to $3.49 previously. Analysts welcomed the lower guidance seeing it as somewhat of a relief and an opportunity to reset on the back of the company’s share price, which has fallen sharply over the last year.
Xeltis BV has secured CE mark approval for Axess, its restorative vascular access conduit for hemodialysis. The company also released 12-month data from its EU pivotal trial on the technology, which showed strong durability outcomes, including 79% secondary patency and a very low patency‑related reintervention rate of 1.3 per patient-year, as well as a substantial reduction in infection burden.
Pulnovo Medical Ltd. secured $100 million in a financing round led by Medtronic plc for its pulmonary artery denervation system to treat pulmonary hypertension.
