The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS finalizes MCIT rule; HHS lists permanent waivers of notification; FDA schedules advisory meeting for latest Lutonix model; HHS announces telehealth grants; Telemarketer caught in sting over telehealth fraud; Churn at FDA chief counsel’s office.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomerica, Cognito Therapeutics, Cytosorbents, Jud Care, Medskin Solutions Dr. Suwelack, Microvention, Ortho, Quanterix, Therapixel.
New hires and promotions in the med-tech industry, including: Conventus-Flower, Innovheart, Jumpcode Genomics, Molekule, Pliant Therapeutics, Rapid Medical, Regenesis Biomedical.
Keeping you up to date on recent developments in oncology, including: Study delineates four cell states in glioblastoma; CARs with switches; Activating NK cells without interleukins; Liver metastases are immunosuppressive.
Pharmaceutical pain management has aided billions of patients, but has also created millions of cases of addiction, a problem that is driving research into pain. Omowunmi Sadik of the New Jersey Institutes of Technology, said on a recent webinar that the Biosensor Materials for Advanced Research & Technology (BioSMART) Center, is working on a suite of biosensors that may aid in the detection of the molecular markers associated with pain.
TORONTO – The 2-French Electrophysiology Catheter (2F) had its Canadian launch in mid-December at Toronto’s Sunnybrook Health Sciences Centre where electrophysiologist Benedict Glover used it to map the small, tortuous branches of the coronary sinus in a patient suffering from cardiac arrhythmia. Developed by Toronto-based Baylis Medical Inc., the 2F is expected to work in tandem with the company’s larger 6F catheter to help diagnose comparatively rare but complex heart arrhythmias.
Neuros Medical Inc., a company developing neuromodulation technology to treat intractable post-amputation pain, has raised $38.5 million in a series BB financing. The funds will be used to complete enrollment in its pivotal QUEST clinical trial and to submit a premarket approval application to the U.S. FDA. New investors Amzak Health and Sectoral Asset Management co-led the round.
While the first quarter may be a little slow as the winter COVID-19 surge continues to disrupt business, expect high capital reserves in med tech and life sciences to make 2021 a year for brisk deal activity, according to the 2021 Ernst & Young (EY) M&A Firepower report. In 2020, industry M&A activity fell to the lowest levels since 2014, but the multinational audit and consulting firm found that the industry now has record levels of deal capacity that it is poised to use to accelerate growth coming out of the pandemic.
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