Sonire Therapeutics Inc. initiated a U.S.-based Sunrise II study of Suizenji, its novel ultrasound-guided high-intensity focused ultrasound (HIFU) system designed to ablate pancreatic tumors, after closing an $18 million series A financing round April 15.
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.
Whoop Inc. secured $575 million in a series G funding round at a $10.1 billion valuation to advance its AI-powered wearable platform for personalized and preventive health care. Abbott Laboratories joined the round as a strategic investor, backing the company’s push to expand access to its device amid growing demand.
AI and advanced biotechnology are reshaping South Korea’s med-tech sector, but great technology alone is not enough to build a successful medical device company, speakers said at MedTech Innovator’s Medtech Spotlight: New Impact Korea 2026.
Insight Lifetech Co. Ltd. listed on the Shanghai Stock Exchange’s STAR market via an unprofitable biotech track reinstated last year, with the Feb. 5 IPO raising ¥998.64 million (US$143.93 million).
A jury in a U.S. District Court unanimously found that Medtronic plc violated federal and state antitrust laws relating to its blood sealing surgical devices and must pay $382 million in damages to Applied Medical Resources Corp.
Paragonix Technologies Inc.’s Kidneyvault portable renal perfusion system managed to preserve and enable the reallocation of a donor kidney for more than 29 hours, despite prolonged ischemic time, multiple handoffs and two commercial flights. Throughout the period, the Kidneyvault maintained stable hypothermic preservation, preventing the organ from being discarded and allowing it to be transplanted into a patient.
The U.S. FDA released the latest version of its premarket cybersecurity guidance regarding medical devices, replacing the 2025 edition and offering recommendations on implementing measures for preventing digital attacks or authorized access.
Seventy-three pharmaceutical, biotechnology and medical device companies from mainland China filed for IPOs in Hong Kong this year, a review by BioWorld found. In the second half of 2025, 43 new securities reports were filed on the Hong Kong Stock Exchange, increasing from the 30 applications in the first half.
South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.
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