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 U.S. FDA and CMS are teaming up to give Medicare beneficiaries quicker access to breakthrough medical devices and provide manufacturers with certainty of reimbursement.
Pulnovo Medical Ltd. secured $100 million in a financing round led by Medtronic plc for its pulmonary artery denervation system to treat pulmonary hypertension.
U.S. Health and Human Services (HHS) Secretary Robert Kennedy made his first stop April 16 on a congressional tour in support of President Donald Trump’s proposed fiscal 2027 budget, which would reduce discretional spending for HHS and its agencies by about 12%.
Nearly a year after the first U.S. commercial launch of the multicancer molecular residual disease (MRD) detection platform Pathlight, developer Saga Diagnostics entered a definitive merger agreement under which Roche Holding AG subsidiary Foundation Medicine Inc. will take over the firm in return for up to $595 million in payments.
Abbott Laboratories saw its shares fall in early trading April 16 after cutting its guidance for 2026 on the back of dilution related to its $21 billion acquisition of Exact Sciences Corp. The company revised its full year adjusted earnings per share guidance to $5.38 to 5.58, down from $5.55 to $5.80 previously. The updated outlook includes 20 cents of dilution related to the Exact deal. Abbott also reported first quarter profits of $1.08 billion, down 18.7% from a year ago.
Despite key vacancies, ongoing staffing challenges and policy issues at the U.S. CDC, FDA and NIH, some of the regulatory churn that roiled those agencies in the first year of the second Trump administration is settling a bit, at least in terms of the number of executive orders (EOs) coming out of the Oval Office.
Regeneron Pharmaceuticals Inc. is entering the radiopharmaceutical space via a collaboration with Telix Pharmaceuticals Ltd. to jointly develop and commercialize next-generation radiopharmaceutical therapies.
Avanos Medical Inc. has agreed to be acquired by affiliates of American Industrial Partners (AIP) in an all-cash deal valuing the company at approximately $1.272 billion. Under the terms of the definitive agreement, Avanos stockholders will receive $25 per share in cash for each share of common stock they hold.
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