Hologic and Bayer today announced an international partnership focused on improving breast cancer detection. The companies teamed up to deliver contrast-enhanced mammography (CEM) solutions across Europe, Canada and Asia Pacific. CEM, a highly sensitive, relatively low-cost breast imaging modality, combines digital mammography with contrast agent administration. It supports breast cancer diagnosis and guides treatment decisions. […]
Women's Health
FDA grants de novo nod to BlueWind Medical’s neuromod for urinary incontinence
BlueWind Medical announced today that the FDA granted a de novo marketing request for its Revi neuromodulation system. Park City, Utah-based BlueWind designed Revi as a tibial neuromodulation system for treating the symptoms of incontinence. It treats urgency incontinence alone or in combination with urinary urgency. De novo approval for men and women with urge […]
iCad to integrate Google AI into mammography workflow
iCad (Nasdaq:ICAD) announced today that it amended its development and commercialization agreement with Google Health. The amendment enables iCad to integrate Google’s AI technology with its ProFound Breast Health Suite for 2D mammography. It intends to integrate the AI capabilities upon regulatory approval as an independent reader for breast cancer screening. ProFound Detection, a high-performance […]
Accuray gets FDA nod for breast cancer treatment on Radixact system
Accuray (Nasdaq:ARAY) announced that the FDA granted 510(k) clearance to its VitalHold breast package on the Radixact system. The company also says it expects the treatment option to become available in Europe. VitalHold facilitates deep inspiration breath hold (DIBH) treatments. It uses the Radixact System’s fixed beam angle delivery mode (TomoDirect) and fully integrated, automated […]
Cooper Companies abandons $875M Cook Medical Reproductive Health business acquisition
The FTC issued a statement announcing that it learned that the Cooper Companies terminated its planned acquisition of a Cook Medical business. In February 2022, Cook Medical signed a letter of intent to sell its Reproductive Health business to CooperCompanies. The deal totaled $875 million. Cooper agreed to pay $675 million at closing and the […]
Hologic stock dips on Q3 losses, questions over future margins
Hologic shares fell this morning despite third-quarter results that topped the consensus forecast. Shares of HOLX dipped 4% at $76.29 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 0.6%. The Marlborough, Massachusetts-based women’s health and diagnostics company posted losses of $40.5 […]
Integra Lifesciences completes enrollment in DuraSorb monofilament mesh IDE study
Integra LifeSciences announced that it completed enrollment ints U.S. DuraSorb trial. The FDA investigational device exemption (IDE) clinical study evaluates DuraSorb in two-stage breast reconstruction. The bioabsorbable matrix-based monofilament mesh currently has FDA clearance to reinforce soft tissue where weakness exists. Princeton, New Jersey-based Integra said its study marks the first and only active, multi-center […]
Invo wins FDA clearance for expanded InvoCell labeling
Invo Bioscience (Nasdaq:INVO) announced that the FDA granted 510(k) clearance to expand the labeling on its InvoCell device. Sarasota, Florida-based Invo’s InvoCell indication now includes a five-day incubation period. Data supporting this clearance demonstrated improved patient outcomes for the device, which previously had a three-day incubation period. The company designed InvoCell to allow fertilization and […]
BD wants to increase education on sexually transmitted infections
Earlier this year, BD shared results from a survey of more than 1,000 U.S. women found significant discrepancies in education around sexually transmitted infections (STIs). Of these women, over 18 years old, 77% identified as knowledgeable about vaginal infections, including yeast infections. However, only 60% said they felt knowledgeable about treatment options for these infections […]
Hologic turns to Eagles rookie Kelee Ringo and his mom to raise mammograms awareness
Hologic (Nasdaq:HOLX) today announced a new partnership with recently drafted NFL quarterback Kelee Ringo and his mother. The partnership with Ringo and his mother, breast cancer survivor Tralee Hale, aims to provide education around breast health. That includes the importance of prioritizing annual mammograms and other key health screenings. Last month, the Philadelphia Eagles drafted […]
Shockwave Medical launches new coronary IVL catheter
Shockwave Medical (Nasdaq:SWAV) today announced full commercial availability for its C2+ coronary intravascular lithotripsy (IVL) catheter. The company designed its C2+ coronary IVL catheter to treat severely calcified coronary artery disease using pulsatile sonic pressure. Santa Clara, California-based Shockwave, which has been subject to recent acquisition speculation, launched the catheter in select international markets. Shockwave C2+ is […]
