Precardia Inc. received some good news from the U.S. FDA, which has granted the company's catheter-based system for treating volume overload in patients with acutely decompensated heart failure (ADHF) breakthrough device designation. The device is intended to quickly reduce congestion in the venous system, known as cardiac preload, with an eye toward improving overall cardio-renal function. Read More

Sommetrics Inc. said Tuesday that it has requested emergency use authorization from the U.S. FDA to market its Aersleep II device for sleep apnea patients at risk of COVID-19. The aim is to reduce the transmission of SARS-CoV-2, the virus that causes COVID-19, by treating infected patients with sleep apnea with Aersleep instead of continuous positive airway pressure (CPAP) therapy. Read More

The bad news is, yes, the U.S. is in for a second wave of COVID-19, which is expected to hit during the upcoming flu season. The good news is the nation is much better prepared for the next wave, the NIH’s Anthony Fauci told a House Energy and Commerce Committee Tuesday. Read More

The Senate Health, Education, Labor and Pensions (HELP) Committee met again June 23 to discuss the federal government response to the COVID-19 pandemic, and one clear signal that emerged from the hearing is that Congress will have to provide annual funding to build a sustainable infrastructure for vaccine development and manufacture if the nation is to deal appropriately with the next pandemic. Read More

Adarza Biosystems Inc.’s Ziva platform can simultaneously detect hundreds of proteins, antibodies, or substrates from a single drop of blood, plasma or serum, providing insight into an individual’s immune response. That could be critical for both surveillance and diagnostic purposes as the nation prepares for a likely second wave of the novel coronavirus in the fall when multiple respiratory pathogens will be circulating. Read More

New hires and promotions in the med-tech industry, including: Bendit Technologies, Scapa Group, Sprintray. Read More

Med-tech firms raising money in public or private financings, including: Brightinsight, Carlsmed. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Draper, Rewalk, Viewray. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apple, Archerdx, Artegraft, Bertin Instruments, Bioskryb, Brite-Strike Technologies, Demetech, Golden Vine International, Hawkeye Systems, Illumina, Inovio Pharmaceuticals, Illumina, Invictus Medical, Invitae, Invo Bioscience, Karten Design, Lemaitre Vascular, Litecure, Mbio Diagnostics, Misty Robotics, Myocardial Solutions, Nano-X Imaging, Northeast Scientific, Ocutrx Vision Technologies, Pathgroup, Pathogendx, Qiagen, Sengenics, Transenterix, Vitanova Biomedical, Xatek, Zimmer Biomet. Read More

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akili, Apyx Medical, Companion Medical, Miracor Medical, Neoteryx, Preceptis Medical, Royal Philips. Read More

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ASTM International, DFC. Read More

Keeping you up to date on recent developments in oncology, including: Focused ultrasound may help thwart glioblastoma; Manipulating the macrophage for cancer therapy; FDA’s oncology center initiates patient voice program; FDA’s oncology center initiates patient voice program; Sedentary behavior predictive of cancer mortality. Read More