Fisher Wallace Laboratories of New York has filed a citizen’s petition with the U.S. FDA regarding the agency’s proposed class III designation for cranial electrotherapy stimulators (CES) for treatment of depression. The company argued that the agency disallowed evidence at an advisory hearing regarding this therapy provided by direct rather than alternating current, but also that the FDA had reneged on an earlier decision to classify these devices as class II devices. Read More
HONG KONG – Yokneam, Israel-based Serenno Medical Ltd. has unveiled a device for automatic monitoring and detection of kidney damage in patients. Known as Sentinel, the device is a continuous urine output (UO) monitor that measures urine flow rate and volume in real time. Read More
Medtronic plc, of Dublin, blamed dampened demand for heart devices ahead of new product launches for its third-quarter revenue miss. Fiscal 2020 Q3 revenue totaled $7.72 billion, below Wall Street’s estimate of $7.81 billion, for organic sales growth of 2.6% vs. consensus and guidance of 4% or higher. Read More
Ferrum Health Inc., of San Francisco, is looking to prevent medical errors with the help of artificial intelligence (AI). That caught the eye of Sutter Health, a not-for-profit health care network in Northern California. To that end, the two have unveiled the debut of Ferrum's AI-powered platform as the system to deliver more consistent care to patients. Read More
HONG KONG – South Korea’s venture capital investment in the biopharma and medical sector set a new record in 2019. According to Korea Venture Capital Association (KVCA), local VC firms invested ₩1.1 trillion (US$930 million) over a total of 299 bio and medical ventures last year, representing 25.8% of the total VC investment executed in 2019. Read More
SEATTLE – Tracing the family tree of COVID-19 through its evolving DNA sequence makes it possible to disprove many false claims circulating on social media about the novel coronavirus, and, in particular, that it was generated in a covert biological weapons program. Read More
New hires and promotions in the med-tech industry, including: Current Health, Eitan Group, Laboratory for Advanced Medicine, Mevion Medical Systems, Mmi, Proscia. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agendia, Angle, Itamar Medical, Laminate Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Acutus Medical, Additive Implants, Cerus Endovascular, Northstar Medical. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: 10X Genomics, Bio-Rad Laboratories, Sanofi SA. Read More
Keeping you up to date on recent developments in oncology, including: New approach to photothermal treatment beats biofilm problem; Origin story helps ovarian cancer prognosis; Sharper look yields new potential kinase target in ovarian cancer; Autophagy activation may prevent metastasis. Read More
