iCad (NSDQ:ICAD) today announced that the third version of its ProFound AI for digital breast tomosynthesis (DBT) has won CE mark approval. Compared with previous software versions, the latest generation of ProFound AI offers up to a 10% improvement in specificity performance while maintaining a high sensitivity level, and approximately 40% faster processing on the new […]
Women's Health
Merck spinoff Organon completes Alydia Health acquisition
Merck (NYSE: MRK) spinoff Organon (NYSE:OGN) today announced the completion of its acquisition of Alydia Health for up to $240 million. Alydia Health develops treatments centered around preventing maternal morbidity and mortality caused by postpartum hemorrhage (PPH) or abnormal postpartum uterine bleeding. The company designed its Jada system to control and treat abnormal postpartum uterine […]
Ibex AI-enabled breast cancer diagnostic lands CE mark
Ibex Medical Analytics announced today that it received CE mark approval for its Galen AI-based breast cancer diagnostic platform. Tel Aviv, Israel–based Ibex’s Galen platform uses AI and machine learning technology based on hundreds of thousands of image samples scanned from biopsy slides through digital pathology, according to a news release. Galen previously won CE […]
Feds want more input on materials with ‘high-profile safety concerns’
The FDA today asked the public to submit comments on how devices that contain certain materials should be labeled. The materials are ones to which patients have long-term exposure — contact time exceeding 30 days — and that have presented “high-profile safety concerns,” according to the agency. They include female sterilization devices, metal-on-metal hips and […]
Memic may go public through merger with SPAC
Memic Innovative Surgery is reportedly eyeing a move to go public through a merger with SPAC MedTech Acquisition Corp. Bloomberg reported that people with knowledge of the matter say that Memic, which develops Hominis, the first FDA-approved, robotically assisted surgical device for performing transvaginal hysterectomy, is in talks over going public with the SPAC. A […]
This imaging device could be a breast cancer treatment breakthrough
OncoRes Medical’s system may detect cancer cells on a microscopic scale during a lumpectomy, potentially averting the need for a second breast cancer surgery. Having breast surgery to remove a cancerous lump is traumatic enough. Learning that you’ll need another operation to remove cancer cells that the surgeon couldn’t detect the first time only adds […]
Axonics closes $201.3M offering
Axonics (NSDQ:AXNX) announced today that it closed a public offering of common stock worth proceeds of more than $200 million. Irvine, Calif.-based Axonics, which develops the Axonics r-SNM (sacral neuromodulation) system to treat bladder and bowel dysfunction, offered more than 4 million shares of its common stock at $50 per share, according to a news […]
Hologic launches $20M women’s health equity initiative
Hologic this week announced an effort to improve healthcare for Black and Hispanic women in the U.S. Project Health Equality (PHE) will focus initially on how Black and Hispanic women experience healthcare in different regions of the country and on making meaningful, sustainable improvements, according to the Marlborough, Mass.-based company. Hologic’s partners in the $20 million initiative […]
Axonics announces $150M offering
Axonics (NSDQ:AXNX) announced today that it commenced a proposed public offering of common stock worth $150 million. Irvine, Calif.-based Axonics, which develops the Axonics r-SNM (sacral neuromodulation) system to treat bladder and bowel dysfunction, also expects to grant underwriters a 30-day option to purchase up to $22.5 million in additional shares of its common stock, […]
Alife raises $9.5M seed financing
Alife Health announced today that it raised $9.5 million in seed financing for its technology designed to improve fertility care. San Francisco-based Alife’s AI-based technology aims to offer personalized treatment recommendations to help clinicians improve a patient’s chances of success with in vitro fertilization (IVF) with lower costs and fewer accessibility barriers, according to a […]
Butterfly Network partners with Sientra on ultrasound for breast implant patients
Butterfly Network (NYSE:BFLY) and Sientra (NSDQ:SIEN) announced today that they are partnering to aid plastic surgeons in breast implant evaluations. Through the partnership, plastic surgeons can use Butterfly Network’s Butterfly IQ and Ultrasound-on-Chip technology to evaluate Santa Barbara, Calif.–based Sientra’s breast implants, according to a news release. Guilford, Conn.–based Butterfly Network’s Butterfly IQ handheld ultrasound […]
