Boston Scientific Corp. said it is initiating a global, voluntary recall of all unused inventory of the Lotus Edge aortic valve system, blaming complexities associated with the product delivery system. The Marlborough, Mass.-based company emphasized that the valve itself continues to achieve positive and clinically effective performance post-implant. However, because of the time and investment needed to develop and reintroduce a delivery system, the company believes it is necessary to retire the entire Lotus platform immediately. Read More
Medtronic plc's cryoablation could soon put drug therapy on ice in parts of the atrial fibrillation (AF) market, based on results of studies published in the New England Journal of Medicine (NEJM) and presented at the American Heart Association Scientific Sessions 2020. Read More
The question of whether the U.S. FDA will review emergency use authorizations (EUAs) for lab-developed tests (LDTs) for the COVID-19 pandemic has bounced around frequently in recent weeks, and Brett Giroir of the Department of Health and Human Services has resurrected the issue. Read More
The European Commission has awarded the CE mark to Hologic Inc. for its Genius Digital Diagnostics system for cervical cancer screening. According to the company, it is the first digital cytology platform to combine a new artificial intelligence (AI) algorithm with advanced digital imaging to assist cytotechnologists and pathologists in detecting precancerous lesions and malignant cells in women. Read More
Researchers at the University of California at San Francisco have developed a method to diagnose any known pathogen from any body fluid within a day – or, depending on the sequencing method, within a few hours. For an unknown pathogen, the method spits out its nearest known relative. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: WHO targets cervical cancer; More time to comment on instituting PTAB trials. Read More
New hires and promotions in the med-tech industry, including: Day Zero Diagnostics, Imperative Care, Medlite ID, Sophia Genetics, Tivic Health Systems, Veracyte. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Castle Biosciences, Rhythm AI, Sino Medical, Smith+Nephew, Spineology. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ab Medica, Brain Scientific, Burning Rock Biotech, Clalit, Diomics, Edap Tms, Elitechgroup, Healthy.io, In2bones Global, Infinity Angioplasty Balloon, Invibio, Irras, Itamar Medical, Kohlberg Kravis Roberts, Life Image, Medrhythms, Myriad Genetics, Nanostring Technologies, Pear Therapeutics, Pharmajet, Premier, Radiomedix, Roux Institute, SyntheticMR, Sysmex, Tempus, Vect-Horus, Zebra Medical Vision, Zeus Health, Zoll. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3D Systems, Allotrope Medical, Co-Diagnostics, Hologic, Safkan, Sommetrics, Tissium. Read More
Keeping you up to date on recent developments in oncology, including: Prolonged androgen-deprivation therapy confirmed as hit on CV health; Nanoparticle fights pancreatic cancer’s chemo resistance; Linking two liver cancer culprits; Reversal of pumping direction is reversal of fortune for tumor cells; Active surveillance backed for Black men with prostate cancer. Read More
