Vertebral compression fractures are one of the more obvious signs of osteoporosis but can be difficult to diagnose, one of several reasons the U.K. National Institute for Health and Care Excellence has given the nod to five AI products that can improve rapid detection of these fractures.
Edap TMS SA signed a €36 million (US$42 million) multi-tranche credit facility with the European Investment Bank, with the first tranche of €11 million expected to be disbursed in early November. The funds will be used to strengthen the company’s balance sheet to support the continued expansion of its Focal One high-intensity focused ultrasound technology in focal therapy and accelerate the development of new clinical indications.
While positive results from the investigator-led phase II CHOPIN trial at the 2025 European Society of Medical Oncology (ESMO) Annual Congress being held in Berlin failed to get investors dancing, they were no doubt music to management’s ears, particularly with Delcath Systems Inc.’s third quarter earnings report missing a beat.
Histosonics Inc. signed an exclusive distribution agreement with Gunze Medical Ltd. to bring its novel histotripsy-based therapeutic model, the Edison System, to Japan. The strategic alliance with Gunze Medical, a wholly owned subsidiary of Osaka, Japan-based Gunze Ltd., paves a figurative runway for Histosonics to introduce its Edison platform in Japan — one of Asia’s largest medical device markets.
Ottobock SE & Co. KGaA got the Frankfurt Stock Exchange on its feet and dancing with Germany’s largest IPO in more than 18 months Oct. 9. The €808 million (US$934.23 million) gave the prosthetics company a market capitalization of €4.2 billion (US$4.88 billion), which rapidly rose as the share price shot up from €66 to €72 at the start of trading. The second med-tech to go public in October should have more company soon, with U.S. molecular diagnostics company Billiontoone Inc. filing Oct. 7 for an IPO with placeholder value of $100 million.
Owlstone Medical Ltd. has been awarded up to $49.1 million in funding by the Advanced Research Projects Agency for Health (ARPA-H) to develop over-the-counter, at-home, cancer screening tests. These tests will be able to accurately detect more than 30 cancers as early as stage I, when tumors are still small and survival rates are highest, revolutionizing the field of cancer detection and improving patient outcomes.
Icecure Medical Ltd. reported that the U.S. FDA has granted marketing authorization to Icecure's de novo application for the Prosense cryoablation system for the local treatment of breast cancer in patients 70 years of age or older with biologically low-risk tumors. The authorized indication includes patients that are not suitable for surgery for breast cancer treatment.
Palmetto GBA, the Medicare administrative contractor for most of the southeastern U.S., has opened a coverage analysis for the use of irreversible electroporation for a variety of cancers, but Palmetto has made it clear that it is unwilling to cover the procedure pending additional evidence.
Phase Scientific International Ltd. launched China’s largest clinical study for urine-based cervical cancer screening. If successful, the blood-based test could be the first non-invasive test for HPV.
In what represents the first filing to have emerged in the name of Cellect Laboratories Inc., one of the start-up’s co-founders, Claire Theresa Murphy, describes their development of a non-invasive screening method that could one day replace the Pap test.