Abbott Laboratories received U.S. FDA clearance for its Lingo and Libre Rio over-the-counter continuous glucose monitoring systems, enabling it to challenge Dexcom Inc. in this rapidly growing market. Dexcom received FDA clearance for its OTC Stela continuous glucose monitor in March.
Amber Therapeutics Ltd. has raised $100 million in a series A funding round to further develop its implantable closed-loop bioelectrical therapy to treat women suffering from mixed urinary incontinence. The financing is one of the largest series A rounds ever seen in Europe’s medical technology space and comes at a time when many med-tech companies are struggling to raise funds.
The med-tech industry has maintained its financing momentum into May, with the first five months of 2024 raising $12.7 billion, marking a 42% increase from $8.95 billion during the same period in 2023. Notably, May alone saw $5.05 billion in total med-tech financings, a 307% rise from $1.24 billion in April, and the highest monthly total reported by BioWorld MedTech since November 2022.
In what represents its first patenting Demon Curonix BV is seeking protection for a system for providing microvesicles to be used in combination with focused ultrasound for drug delivery to the brain.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Roche, Siemens Healthineers.
Australian radiopharmaceutical company Telix Pharmaceuticals Ltd. announced its IPO on the Nasdaq to raise $200 million to advance its late-stage radiopharma candidates. Headquartered in Melbourne, Telix has operations in the U.S., Europe (Belgium and Switzerland) and Japan with an extensive pipeline of theranostic radiopharmaceutical candidates.
Moon Surgical SAS recently received U.S. FDA clearance for the commercial version of its Maestro surgical robotic system for laparoscopic procedures. The greenlight is “pretty massive” for the company as it will allow the robotic platform to be rolled out in the U.S., to help enhance the surgeon’s performance while carrying out procedures, Anne Osdoit, CEO of Moon Surgical, told BioWorld.
South Korean digital health care firm Seers Technology Co. Ltd. is targeting a ₩22.1 billion (US$16.2 million) IPO on the Korea Exchange, after upping the offering price of its 1.3 million shares to ₩17,000 per share on June 4.
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