Invo Bioscience (OTCQB:IVOB) announced today that it acquired a Canadian-based entity formed to offer its InvoCell platform in Canada. The unnamed entity previously completed a number of important procedures and the documentation required to establish InvoCell within clinical operations in Canada, according to a news release. The acquisition included a $25,000 cash payment and 30,000 […]
Women's Health
Madorra wins FDA breakthrough nod for home vulvovaginal atrophy treatment device
Madorra this week said it has received FDA breakthrough device designation for its noninvasive, home-use device for moderate to severe vulvovaginal atrophy. Through the breakthrough device program, Madorra will have priority review and communication regarding the development of the device until the product goes on the market. Madorra’s handheld device is designed as a prescription, […]
Boston Scientific completes $1.1B Lumenis acquisition
Boston Scientific (NYSE:BSX) announced today that it completed the nearly $1.1 billion acquisition of the global surgical business of Lumenis. Marlborough, Massachusetts–based Boston Scientific announced in March that it entered into a definitive agreement with an affiliate of Baring Private Equity Asia (BPEA) to acquire Lumenis’ surgical business, which develops and commercializes energy-based medical solutions. […]
Memic Innovative Surgery to go public via SPAC merger
Memic Innovative Surgery announced that it entered into a merger agreement with special purpose acquisition company MedTech Acquisition Corp. Tel Aviv, Israel-based Memic will operate under its current name upon the closing of the transaction, with Dr. Maurice R. Ferré — an independent director of MedTech and current chairman of Memic — will serve as […]
Hologic beats The Street as Q3 profits nearly double
Hologic (NSDQ:HOLX) posted third-quarter results that beat the overall consensus on Wall Street. The Marlborough, Mass.-based women’s health and diagnostics tech company reported profits of $268.1 million, or $1.04 per share, on sales of $1.2 billion for the three months ended June 26. The results out yesterday evening represented a bottom-line gain of 96.6% on […]
Establishment Labs CFO stepping down, interim replacement announced
Establishment Labs today announced that its chief financial officer Renee Gaeta will be stepping down later this month and Raj Denhoy will be her interim replacement. Santa Barbara, Calif.–based Establishment Labs — maker of Motiva Implants for breast reconstruction — said Gaeta is stepping down to pursue other opportunities outside of the company on July […]
SCOTUS preserves assignor estoppel in Minerva Surgical v. Hologic patent case
The U.S. Supreme Court, in its Minerva Surgical v. Hologic ruling today preserved the legal doctrine of assignor estoppel — that inventors who sell patent rights can’t then claim they’re invalid. However, Justice Elena Kagan, in her opinion for the majority, did say that the doctrine has limits. Get the full story on our sister […]
Latest iCad 3D mammography AI gains CE mark
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 […]
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 […]
