Pomdoctor Ltd. raised $20 million through a Nasdaq IPO on Oct. 8, with the funds geared to expand its mobile health platform for chronic diseases in China.

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.

The International Medical Device Regulators Forum (IMDRF) has issued a draft guidance for predetermined change control plans for software as a medical device. The problem for advocates of regulatory harmonization is that the IMDRF draft overlaps awkwardly with the FDA’s approach, which has issued separate policies for the AI subset of device software functions and a separate guidance for all other devices, including non-AI software.

Owens & Minor Inc. (O&M) is shedding its Products & Healthcare Services (P&HS) segment with an eye towards expanding its leadership position in the home-based care space. The company has agreed to sell its P&HS segment to Platinum Equity, a private equity firm. Platinum will pay $375 million in cash, while Richmond, Va.-based O&M retains a 5% equity stake in the business.

Cala Health Inc.’s KIQ wearable device delivers transcutaneous afferent patterned stimulation through nerves at the wrist that modulate neural activity in the brain and reduces hand tremors in individuals with essential tremor, two recent studies show.

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.

Johnson & Johnson Medtech won out over a jury verdict that found the company’s Depuy Synthes liable for $20 million for infringing a patent claimed by Rasmussen Instruments LLC.

Even though the U.S. CDC is operating on a skeleton crew due to the partial government shutdown, it is updating its immunization schedules to adopt the COVID-19 and chickenpox vaccine recommendations the Advisory Committee on Immunization Practices (ACIP) made at its September meeting.

The brain-computer interface (BCI) system being developed by Precision Neuroscience Corp. is capable of capturing high-resolution brain signals and stimulating areas without damaging the cortical surface, according to a study published in Nature Biomedical Engineering.

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.