The FDA’s response to the COVID-19 pandemic has been matched by device makers, but the ID Now molecular test by Abbott Park, Ill.-based Abbott Laboratories has been the target of recent criticism. Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health, said at a May 20 town hall meeting that Abbott has agreed to yet another study of the ID Now, the terms of which were under negotiation at the time of the meeting. Read More
Vancouver-based Artms Inc. has raised a $19 million series A round to develop its approach to the production of many of the most commonly used diagnostic imaging isotopes. Its Quantm Irradiation System enables the inexpensive production of medical isotopes using hospital-based cyclotrons. Read More
Rapid Micro Biosystems Inc. scooped up $120 million in a series C financing led by Ally Bridge Group, with participation by Endeavor Vision and existing investors Bain Capital Life Sciences, Longitude Capital, Xeraya Capital and Asahi Kasei. The Lowell, Mass.-based company has earmarked the funds to expand the global footprint of its contaminant testing platform for biopharmaceutical and vaccine manufacturing and for new product development. Read More
TORONTO – How confident is Canada’s government that Abcellera Biologics Inc. can identify viral antibodies to help stop COVID-19 in its tracks and build the manufacturing infrastructure for antibody therapies against future pandemic threats? Enough to award the Vancouver, British Columbia-based biotech CA$175.6 million (US$124.7 million) for the application of its antibody discovery platform to the analysis of patients who have recovered from COVID-19. Read More
Proscia Inc., a Philadelphia-based company that focuses on artificial intelligence (AI)-enabled digital pathology solutions, recently made the Concentriq Dx digital pathology software available for use in reviewing and reporting of digital pathology slides in the U.S. during the COVID-19 pandemic. Read More
Just days after Clovis Oncology Inc.'s Rubraca (rucaparib) became the first PARP inhibitor approved by the FDA to treat certain cases of metastatic prostate cancer (mCPRC) in third-line care, the agency granted an even broader label in the indication to its first-in-class competitor, Lynparza (olaparib). Endorsement of second-line use of Lynparza in mCPRC and an overall survival (OS) benefit listed in its updated label will help rapidly establish it as "the drug of choice in the [second] line, leaving little commercial opportunities for Rubraca downstream," SVB Leerink analyst Andrew Berens said. Read More
The challenges to deploy diagnostic and surveillance testing for the COVID-19 pandemic will persist at least until a vaccine is ready if not well beyond that milestone. In our series “Diagnosing the state of COVID-19 testing,” BioWorld MedTechexplores the complexities of developing accurate, properly regulated tests to help bring the world back online with confidence.
Med-tech firms raising money in public or private financings, including: Assure Holdings, BBS-Bioactive Bone Substitutes, Becton Dickinson, Ra Medical Systems. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baxter. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Aetion, Boston Scientific Neuromodulation, Nevro. Read More
Keeping you up to date on recent developments in orthopedics, including: Lab engineers 3D-functional bone tissues; Comparison of early postoperative pain after first vs. second total knee arthroplasty; Vitamin B3 revitalizes energy metabolism in muscle disease; Worldwide IOF-ISCD survey of bone densitometry units published. Read More
