It’s a sure bet when the U.S. Trade Representative releases its annual Special 301 Report that Chile, China, India, Indonesia, Russia and Venezuela will be on the Priority Watch List. The 2026 report was no exception.
U.S. President Donald Trump ended days of rumors and speculation when he confirmed May 12 that Marty Makary is resigning as FDA commissioner. Speaking with reporters before heading off to China for a two-day summit, Trump wouldn’t comment on whether he or someone else asked Makary to step down. However, while calling Makary a “wonderful man” and a “great guy, who’s a friend of mine,” the president acknowledged that “he was having some difficulty” at the FDA.
Roche Holding AG secured CE marking for the Elecsys plasma phosphorylated-tau 217 blood test designed to rule in and rule out amyloid pathology, a hallmark of Alzheimer's disease. Developed with Eli Lilly and Co., the test brings to the market another much-needed solution to help clinicians diagnose Alzheimer’s patients following the FDA approval of Fujirebio Diagnostics Inc.’s blood test last year.
Bright Uro Inc. secured U.S. FDA 510(k) clearance for the Glean abdominal sensor, which expands the capabilities of its Glean urodynamics system to enable multichannel urodynamic studies. The new sensor will allow clinicians to perform multichannel urodynamics, capturing both abdominal and detrusor pressures without the need for catheters, supporting treatment decision-making for patients with lower urinary tract dysfunction and other urological conditions.
Med-tech financing activity in the first four months of 2026 reached $10.05 billion, similar to 2025’s $10.31 billion and 2022’s $10.62 billion. While below the peak years of 2019-2021, when financings were above $15 billion in the time period, total value is still above the levels seen in 2023-2024. April saw $1.51 billion raised, compared to $2.44 billion in March, $4.55 billion in February and $1.52 billion in January.
Mobia Medical Inc. began trading on Nasdaq under the ticker MOBI on May 8. The company priced its IPO at the midpoint of its proposed $14 to $16 range, selling 10 million shares at $15 each and raising approximately $150 million. The stock closed at $11.75 its first day of trading, down 21.7%.
Roche Holding AG has agreed to acquire Pathai Inc. for up to $1.05 billion in a bid to strengthen its position in digital pathology and enhance its biopharma services. The move builds on a partnership established between the two companies in 2021, and expanded in 2024, to include the development of AI-enabled companion diagnostic algorithms.
Even before the U.S. FDA announced its one-day inspection pilot May 6, it already had test-flown 46 of the shorter inspections across several of its centers.
Star Sports Medicine Co. Ltd. debuted on the Hong Kong Stock Exchange with an HK$829.55 million (US$105.86 million) IPO May 5, with shares closing about 118% higher on the first day.
It’s a sure bet when the U.S. Trade Representative releases its annual Special 301 Report that Chile, China, India, Indonesia, Russia and Venezuela will be on the Priority Watch List. The 2026 report was no exception.
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