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 […]
Gynecological
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 […]
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 […]
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 […]
Intuitive Surgical must face electrified scissors lawsuit
A U.S. appeals court revived a lawsuit alleging that flawed electrical scissors from Intuitive Surgical were used during a hysterectomy. The appeals court panel ruled that a lower court applied the wrong legal standard in dismissing Tamanchia Moore’s lawsuit against Intuitive. Specifically, the district court erred by excluding Moore’s causation expert, according to the ruling […]
Memic raises $96M to support surgical robot with humanoid-shaped arm
Memic Innovative Surgery announced today that it closed a $96 million Series D financing round. Tel Aviv, Israel-based Memic develops Hominis, the first FDA-approved robotically-assisted surgical device for performing transvaginal hysterectomy, with indication for performing benign hysterectomy with salpingo-oophorectomy. The FDA approved the Hominis system last month. Hominis is designed to remove the uterus using […]
UroMems adds $8.3M, brings Series B round to $27.3M
UroMems announced today that it added $8.3 million to its Series B financing round, bringing the total funds raised to $27.3 million. Grenoble, France-based UroMems’ $27.3 million (€23 million) financing round had its first tranche completed in May 2020 but added the $8.3 million (€7 million) thanks to existing investors including Hil-Invent GmbH, Financière Arbevel, […]
FDA clears point-of-care STI test
The FDA announced today that it authorized the Binx Health IO CT/NG assay at point-of-care settings to diagnose STIs. Point-of-care settings include physician offices, community-based clinics, urgent care settings, outpatient healthcare facilities and other patient care settings operating under a CLIA certificate of waiver, certificate of compliance or certificate of accreditation, according to a news […]
Merck spinoff Organon to acquire Alydia Health for up to $240M
Merck (NYSE: MRK) announced today that it entered into an agreement for its spinoff Organon to acquire Alydia Health for up to $240 million. Alydia Health develops treatments focusing on preventing maternal morbidity and mortality caused by postpartum hemorrhage (PPH) or abnormal postpartum uterine bleeding, according to a news release. The company develops the Jada […]
Boston Scientific settles host of state pelvic mesh lawsuits for nearly $189M
Boston Scientific (NYSE:BSX) has agreed to pay $188.6 million to 47 states and the District of Columbia to resolve claims that it deceptively marketed transvaginal surgical mesh devices, state AGs announced today. Pelvic mesh products have been one of the medical device industry’s worst failures so far in the 21st century. First cleared nearly two […]