Australia’s Therapeutic Goods Administration recently reported that it has concerns about the use of digital scribes, stating that any such software that analyzes or interprets clinical conversations may qualify as a regulated medical product.
Celltrion Inc. said it would acquire Iqone Healthcare Switzerland SA in the fourth quarter of 2024 for about ₩30 billion (US$21.34 million) to expand its European business. “This move represents a strategic shift in our growth strategy,” Taehun Ha, Celltrion vice president and Europe head, said in a statement Nov. 15.
Celltrion Inc. said it would acquire Iqone Healthcare Switzerland SA in the fourth quarter of 2024 for about ₩30 billion (US$21.34 million) to expand its European business. “This move represents a strategic shift in our growth strategy,” Taehun Ha, Celltrion vice president and Europe head, said in a statement Nov. 15.
Novocure GmbH secured U.S. FDA approval for Optune Lua, a wearable device that delivers alternating electric fields or tumor treating fields that kill cancer cells. Indicated for use with PD-1/PD-L1 inhibitors or docetaxel in the second or subsequent line for the treatment of metastatic non-small-cell lung cancer following the failure of platinum-based regimens, the approval was driven by the significant improvement in overall survival rates seen in the LUNAR pivotal study for Optune Lua.
The German med-tech associations Bvmed and VDGH have hit out at the shortcomings of the EU medical device regulations and are calling for action to improve implementation, predictability and transparency of the system.
Medalliance SA reported completion of patient enrollment in the SAVE clinical trial with its Selution SLR 018 drug-eluting balloon. Eighty-four subjects have been recruited for this prospective multi-center, single-blinded, randomized controlled trial. These patients received either standard high-pressure balloon angioplasty followed by local application of Selution SLR, or else high-pressure balloon angioplasty with no further lesion treatment.
Five months after raising $45 million, Lunaphore Technologies SA reported its consent to be acquired by Bio-Techne Corp., a reagents and instruments manufacturer for the diagnostic market. This acquisition by the Nasdaq-listed bio-tech giant, “will enable us to begin a worldwide commercial rollout of our products and automated spatial biology technology,” Ata Tuna Ciftlik, co-founder and CEO of Lunaphore Technologies, told BioWorld. The amount of the transaction was not disclosed. This acquisition is expected to close in the third quarter of 2023.
Swiss biotech firms raised CHF1.3 billion (US$1.5 billion) in equity and debt financing in 2022, a fall of 60% from the previous year’s total of over CHF3.3 billion. But it’s still ahead of historic pre-pandemic levels of funding.
Implantica AG reported that the first two Refluxstop procedures to treat acid reflux have been performed at Getafe University Hospital in Spain. Trial results indicate that the single-use passive medical implant can cure reflux in 98% of cases without the need for medication.
Feeling “ashamed” of having to use metal flesh-piercing forceps to stabilize the cervix during the insertion of intrauterine contraceptive devices, David Finci a gynecologist and co-founder of Aspivix SA, turned to his brother Julien, a medical device engineer, for his thoughts on how to design a more suitable instrument.
