My Blue Dots

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

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted and granted Priority Review in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) who have received prior systemic therapies, including an EGFR-directed therapy. The Food and Drug Administration (FDA) grants Priority Review to

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

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

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

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

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

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

NEW YORK & PITTSBURGH–(BUSINESS WIRE)–TruFood Manufacturing (“TruFood”) and Bar Bakers, LLC (“Bar Bakers”) are proud to unveil their new unified brand identity: Tandem Foods, a premier contract manufacturer specializing in better-for-you snacks. The milestone builds on the successful Spring 2024 merger of the two companies, marking the evolution of two trusted brands, creating the industry leader in the nutrition bar space. The enterprise is unified by its dedication to driving customer growt