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.

Tensive Srl's Regenera, a bio-absorbable breast implant, promises to help the millions of women who undergo breast cancer surgery every year, to feel whole again. “While surgery will save many lives, it comes at the cost of losing something very personal, which is the sense of a woman's wholeness. I think that's what has been a major challenge,” Sanjay Kakkar, CEO told BioWorld.

Goodpath Inc., a virtual provider of whole-person care for chronic conditions, raised $18 million in series A financing, led by Massmutual Ventures with participation from Healthy Ventures and current investors.

Exact Sciences Corp. rolled out its multi-cancer early detection test nationwide to expand screening and identify malignancies when treatment has the greatest chance of being curative. Cancerguard can detect signals for cancers accounting for more than 80% of all cancer diagnoses in the U.S. each year.