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.

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.

Resmed Corp. has agreed to acquire Noctrix Health Inc. for $340 million, boosting its sleep health portfolio. Noctrix has developed Nidra, a wearable neuromodulation device which treats restless legs syndrome (RLS) without disrupting sleep. With RLS impacting approximately 7% of adults globally, including about 17 million people in the U.S., the technology offers a non-drug option that could potentially treat a significant proportion of this patient population.

Medical Microinstruments Inc.’s (MMI) Symani surgical system was used to treat a patient with Alzheimer’s disease as part of a study evaluating robotic-enabled microsurgery for the condition. The procedure investigated whether restoring lymphatic drainage pathways in the deep cervical lymph nodes could improve the clearance of harmful neurotoxins believed to contribute to the progression of Alzheimer’s.

Hypervision Surgical Ltd. raised £17 million (US$23 million) in a series A financing round for its platform technology which combines spectral sensing with cloud-enabled AI analytics, to give surgeons real-time insights into tissue physiology during surgery that were previously impossible to see.

The European Medicines Agency (EMA) has launched a pilot program to fast track breakthrough medical devices in the EU and get lifesaving technologies to patients sooner. The program will allow for companies to obtain scientific advice from the expert panels intended to support evidence generation and clinical development of their devices.

Caredx Inc. has agreed to acquire Naveris Inc., a precision oncology diagnostics company, for up to $260 million, as part of its strategy to accelerate growth. The acquisition comes as Caredx, an organ transplant diagnostic firm, reshapes its portfolio, expanding its oncology profile while recently divesting its lab products business.

Nervonik Inc. raised $52.5 million in a series B financing round for its peripheral nerve stimulation (PNS) system designed to treat patients with chronic pain and other neurological conditions. The funds will be used to support the continued development Nervonik's PNS system, including enhancements to the system’s sensing capabilities, as well as preparations for commercialization.