Lex Diagnostics Ltd. has submitted dual applications to the U.S. FDA seeking 510(k) clearance and CLIA waiver status for its Velo system, an ultra-fast point-of-care molecular diagnostics platform. The move comes after the recent news from Quidelortho Corp. that it intends to acquire Lex for $100 million following U.S. regulatory approval of the technology.

The med-tech industry brought in $13.74 billion from January through May 2025, up from $12.76 billion during the same period last year. In May alone, the sector raised $3.51 billion across 47 transactions, nearly doubling April’s total value of $1.88 billion from 37 deals.

As it advances its nonopioid analgesic ATX-101 breakthrough therapy through a phase IIb registration trial, Allay Therapeutics secured $57.5 million in a series D round, which included an investment from the company’s Japanese partner.

Biopharma financings totaled $21.38 billion through May 2025, down sharply from $62.57 billion during the same period in 2024, but roughly in line with levels seen in 2023 and 2022. Biopharma companies raised $5.55 billion in May, more than doubling the $2.4 billion raised in April.

Aiatella Oy secured €2 million (US$2.28 million) in funding for its AI-powered cardiovascular imaging technology. The funds will be used to conduct clinical trials and develop the company’s ultrasound-based preventative screening tool, which detects and quantifies carotid artery narrowing in minutes.