Sword Health Technologies Inc. slipped another $189 million into its coffers with an oversubscribed $163 million series D fundraising round that spilled into an additional $26 million secondary transaction. The enthusiasm for the round points to the keen interest in digital delivery of musculoskeletal (MSK) physical therapy, which has driven Sword and competitor Hinge Health Inc. both into rarified unicorn territory with valuations of $2 billion and $6.2 billion, respectively. Read More
The European Investment Bank (EIB) pumped €15 million (US$17 million) into Xeltis BV to accelerate clinical programs for its polymer-based technology platform for cardiovascular restoration. The Eindhoven, Netherlands-based company is developing three types of cardiovascular implants. These are a pulmonary heart valve, coronary artery bypass graft and hemodialysis access grafts. The devices use a therapeutic approach called endogenous tissue restoration (ETR), which causes the patient’s own body to naturally restore a new blood valve. As the patient’s healing system develops a functional valve, Xeltis’ implant is gradually absorbed by the body. Read More
PERTH, Australia – Cardiovascular medical device company EBR Systems Inc. announced a planned AU$110 million (US$79.7 million) initial public offering (IPO) on Australia’s Securities Exchange to bring its wireless cardiac pacing system for heart failure to market. The IPO is planned for Nov. 24, 2021, and the funds raised will allow the company to complete pivotal trials for its wireless, inside-the-left-ventricle-of-the-heart pacing system called WiSE (wireless stimulation endocardially). Read More
The U.S. Court of Appeals for the Federal Circuit recently decided an appeal of a patent lawsuit involving Cardionet LLC, of Conshohocken, Pa., invalidating the Cardionet patent for lack of subject matter eligibility. While the patent offers a significant improvement in the functionality of any computer that uses the Cardionet algorithm, the Federal Circuit declared that the invention does nothing more than use the computer as a tool to express an abstract idea. Read More
Former FDA Commissioner Stephen Hahn is being asked to spill the beans on political interference at the U.S. agency during the emergence of COVID-19 last year. Read More
U.S. trading partners are raising concerns about the FDA’s continued delays in inspecting foreign drug manufacturing facilities due to the COVID-19 pandemic and related travel restrictions. Read More
The FDA has continued a series of device risk classifications with the formal announcement that general containment systems used with power morcellators will henceforth be deemed class II, moderate-risk devices. Read More
