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BioWorld - Saturday, December 27, 2025
Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Feb. 26, 2025

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Dollar sign between hands

Kestra Medical ups IPO target to $150M

Reflecting a positive reception in the market, Kestra Medical Technologies Ltd. increased the target haul for its planned IPO from $100 million to between $140 million and $160 million in an S-1 amendment filed Feb. 26. The company will offer 10 million shares at $14 to $16 per share, with the final price to be set the week of Mar. 3, just ahead of the offering date. Read More
Illustration of tumor on kidney

FDA accepts Telix BLA for kidney cancer imaging agent

After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025. Read More
Cancer tumor in breast illustration

Scientists develop scanner to see undetectable breast tumors​

Scientists at the University of Aberdeen developed a new scanner that distinguishes breast tumor material from healthy tissue more accurately than current magnetic resonance imaging (MRI) methods. Read More
us-supreme-court.png

Loper Bright no free pass where FDA’s LDT rule is concerned

The FDA’s final rule for lab-developed tests (LDTs) is in litigation, and a district court decision may be shortly in the works. Read More
regulatory-washington-capital.png

FDA’s LDT rule, CDS guidance combine to complicate regulatory life

The routine use of software to interpret the results of lab-developed tests (LDTs) leaves clinical labs in a complicated spot in 2025 thanks in no small part to an ongoing lawsuit over the U.S. FDA’s final rule for LDTs. Read More
World trade illustration

Five med-tech trends to watch in 2025

The Clarivate Medtech Trends to Watch in 2024 report noted the resilience of the medtech sector in the face of changing macroeconomic factors and the preparation required to navigate the market’s many complexities. It is likely that 2025 will be no different. Read More

Appointments and advancements for Feb. 26, 2025

New hires and promotions in the med-tech industry, including: Affluent Medical, Jupiter Endovascular, Nucleus Genomics, Veda Bio, Zimmer Biomet. Read More

Financings for Feb. 26, 2025

Med-tech firms raising money in public or private financings, including: 4Tissue NV, Basel Medical, Centinel Spine, Heartbeam, Medx Health, Renovaro. Read More

In the clinic for Feb. 26, 2025

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Exthera, Neuspera. Read More

Other news to note for Feb. 26, 2025

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Averto, Bracco, Eyenovia, Lucid, Natera, Sphere Fluidics, Zereau. Read More

Regulatory actions for Feb. 26, 2025

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abanza, Medibeacon, Sway, Visby. Read More

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