MyBlueDots

IMVARIA Receives 510(k) Clearance for ScreenDx, a First-of-its-Kind Screening Algorithm to Assess for Interstitial Lung Disease

BERKELEY, Calif.–(BUSINESS WIRE)– #510k–IMVARIA Inc., a health tech company pioneering AI-driven digital biomarker solutions, today announced its second FDA authorization, securing 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ScreenDx solution, an AI-powered healthcare tool to assist clinicians in assessing for interstitial lung disease (ILD). “ScreenDx is a software‐only device leveraging artificial intelligence to analyze CT imaging data for findings suggestive of inte
Read More

Pulse Biosciences’ Nanosecond PFA Technology to be Featured in Multiple Presentations at the AF Symposium

MIAMI–(BUSINESS WIRE)–Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, today announced that its nsPFA technology will be featured in a late-breaking science session and a live case transmission featuring the nsPFA 360° catheter mapped with the Abbott Ensite X 3D Mapping System at the 30th Annual AF Symposium 2025 meeting, being held January 16-18 in Boston, Massachusetts. “Since joining the Company’s
Read More

Bausch + Lomb Bolsters Pipeline with Acquisition of Whitecap Biosciences

VAUGHAN, Ontario–(BUSINESS WIRE)–Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced an affiliate has acquired Whitecap Biosciences, LLC, which is currently developing two innovative therapies for potential use in glaucoma and geographic atrophy (GA). The acquisition strengthens Bausch + Lomb’s expanding clinical-stage pipeline. “We’re focused on finding treatments that address unmet needs or si
Read More

STAAR Surgical to Host Fourth Quarter and Fiscal Year 2024 Earnings Conference Call and Webcast on February 19, 2025

LAKE FOREST, Calif.–(BUSINESS WIRE)–STAAR Surgical Company (NASDAQ: STAA), the global leader in phakic IOLs with the EVO family of Implantable Collamer® Lenses (EVO ICL™) for vision correction, today announced that it will release financial results for the fourth quarter and fiscal year ended December 27, 2024, on or about Wednesday, February 19 after the market close. “Our industry-leading EVO ICL technology and market-building initiatives supported our ability to achieve double-digit year-o
Read More

Guardant Health Announces Preliminary Fourth Quarter and Full Year 2024 Results

PALO ALTO, Calif.–(BUSINESS WIRE)–Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced preliminary, unaudited results for the quarter and full year ended December 31, 2024. Fourth quarter 2024 preliminary unaudited financial results For the three-month period ended December 31, 2024, as compared to the same period of 2023: Total revenue of approximately $200 million, an increase of 29% Reported approximately 57,300 oncology clinical tests (excluding Shield
Read More

CareDx Announces Preliminary Fourth Quarter and Full Year 2024 Results

BRISBANE, Calif.–(BUSINESS WIRE)–CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ – today reported preliminary, unaudited financial results for the fourth quarter and full year ended December 31, 2024. Preliminary Fourth Quarter 2024 Financial Results Revenue is expected to be between $85 million and $86 million, an increase of approximately 30% year-over-year. Testing services revenue is expected to be between $62.5 million and $63.5 million, an increase of approximately 35% year-over-y
Read More

Advanced Infusion Care (AIC) now offers GC Biopharma’s ALYGLO™ [Immune Globulin Intravenous (Human-stwk) 10% liquid]

DALLAS–(BUSINESS WIRE)–AIC, a division of AIS Healthcare, now offers ALYGLO™, manufactured by GC Biopharma, for the treatment of patients with primary humoral immunodeficiency (PI) in adults. This includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiency (SCID). The nationally accredited home infusion teams at AIC collaborate c
Read More
Top