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, […]
Women's Health
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 […]
Alydia Health appoints VP of sales
Alydia Health this week said it has appointed Paul Praino as its VP of sales. Praino will be responsible for expanding the company’s sales efforts for the Jada System, Alydia Health’s device that is designed to encourage normal contraction of the uterus to rapidly stop excessive bleeding after childbirth. “Paul is an experienced commercial sales […]
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 […]
MTF Biologics says FDA used old data to malign its surgical mesh
A surgical mesh company claims the FDA improperly called one of its products’ safety into question. The agency said last week that two surgical mesh brands used off-label in breast reconstruction surgery have had “significantly higher major complication rates.” It named FlexHD by MTF Biologics and AlloMax by BD as having had higher rates of explantation, reoperations and infections two years […]
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 warns on use of certain surgical mesh in breast reconstruction
Two surgical mesh brands used off-label in breast reconstruction surgery have had “significantly higher major complication rates,” according to an FDA analysis. Patients implanted with FlexHD by MTF Biologics and AlloMax by BD had higher rates of explantation, reoperations and infections two years after surgery when compared with patients who received one of two other […]
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 […]
