Icecure Medical Ltd. submitted data to the U.S. FDA seeking de novo marketing authorization for its Prosense system to treat patients with early stage T1 invasive breast cancer in combination with adjuvant hormone therapy. Prosense is a minimally invasive cryoablation technology that freezes and destroys tumors, both malignant and benign.

The U.S. FDA granted Roche Holding AG breakthrough device designation for the Elecsys pTau217 assay that it is developing with Eli Lilly and Co. The test will help with the earlier diagnosis of Alzheimer's disease as it will be able to identify pTau217, a phosphorylated fragment of the protein tau, which is a biomarker that can distinguish the disease from other neurodegenerative disorders.

Endostart s.r.l. received U.S. FDA 510(k) clearance for Endorail, a magnetic balloon system which helps resolve intestinal looping and facilitates the efficiency and safety of colonoscopy procedures. The approval is an “important milestone” for the company as it will allow Endostart to bring its technology to the U.S. market to empower physicians, Alessandro Tozzi, co-founder and CEO of the company, told BioWorld.

Avicenna.AI SAS received clearance from the U.S. FDA for two of its artificial intelligence (AI)-based solutions, Cina-Ipe and Cina-Aspects, which provide for the detection of pulmonary embolism (PE) and the assessment of stroke severity in CT scans, respectively.

Metyos SAS has raised €2.3 million (US$2.7 million) in pre-seed funding for its biowearable sensor technology which monitors patients with chronic kidney disease (CKD). The funds will be used to progress the technology through clinical trials ahead of FDA approval.

Ultrahuman Healthcare Private Ltd. recently raised $35 million in a series B investment round to accelerate the company’s growth. Ultrahuman has developed several products, most notably a smart ring, which measures a range of physiological signals to impact health and wellbeing.

Johnson Matthey plc agreed to sell its medical device components business to Montagu Private Equity for £550 million ($700 million) on a cash-free, debt-free basis. For Montagu, the deal is part of its expanding health care portfolio. Earlier in 2024 the private equity firm, which is the primary shareholder in RTI Surgical Inc., acquired Cook Biotech Inc. from Cook Medical Inc. and merged the two companies.

Serac Healthcare Ltd.’s imaging agent, 99m Tc-maraciclatide, enables visualization of early-stage endometriosis, preliminary data from a study presented last week at the Society for Reproductive Investigation conference in Vancouver demonstrated. With millions of women suffering from the debilitating condition globally, maraciclatide has the potential to not only help with diagnosis but also with the development of new therapeutics, David Hail, CEO of Serac, told BioWorld.

Vicore Pharma Holding AB was granted a U.S. FDA breakthrough device designation for Almee, a cognitive behavioral therapy (CBT) software, to be used as an adjunct treatment by patients with anxiety symptoms due to pulmonary fibrosis. Vicore developed the nine-week CBT digital therapy in partnership with Alex Therapeutics AB.

Affluent Medical SA said that its artificial sphincter, Artus, which treats stress urinary incontinence, was successfully implanted into the first patient. The company hopes that the device, which is the first artificial urinary sphincter that can be activated by the patient with a remote control, will be able to improve the quality of life of the millions of people suffering from urinary incontinence.