Shockwave Medical Inc. said Tuesday that its intravascular lithotripsy (IVL) therapy has won U.S. FDA approval for the treatment of severe coronary artery disease (CAD). The technology, which was granted breakthrough device designation in 2019, is a novel application of lithotripsy, which has long been used to safely shatter kidney stones. Read More

Cardiacsense Ltd.’s medical watch received CE mark for the detection of atrial fibrillation and heart rate variability monitoring. The watch provides continuous, long-term monitoring of heart arrhythmias without cumbersome external devices or invasive implants. The European clearance does not require a prescription for use and will enable the Caesarea, Israel-based company to begin distribution under a number of agreements the company signed in 2020. Read More

The problem of patent subject matter eligibility is still a nightmare for companies in the diagnostics space, but patent attorney Michael Borella said this is still an issue for software as well. Borella said there are three characteristics that should be considered while drafting patent claims – specificity, technical character and novelty – to arrive at a reasonable assurance that that the key claims in a patent application will survive a challenge in hazardous legal environs, such as the Court of Appeals for the Federal Circuit. Read More

Blue Ocean Spine GmbH has won a major investment from SHS GmbH, also from Tuttlingen in Germany, to develop its next-generation functional spinal implant. The two companies are declining to disclose the size of the series A investment. Read More

TORONTO – Soundbite Medical Solutions Inc. has received Health Canada approval for a shock wave device that jackhammers its way through calcified, chronic total occlusions (CTO) in life-threatening critical limb ischemia (CLI), a severe form of peripheral artery disease. This comes after the Active Wire 0.014” was used for the first time in late January to successfully treat five patients. Read More

BioWorld's offices were closed in observance of Presidents Day in the U.S. No issue was published Monday, Feb. 15. Read More

New hires and promotions in the med-tech industry, including: 1health, Biosig, Brainsway, Clineone, Henry Schein One, Inogen, Organogenesis. Read More

Med-tech firms raising money in public or private financings, including: Mainstay Medical, Novadiscovery, Sanofi. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Avacta, Bandgrip, Biocept, Lumithera, Seegene. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3-a diagnostics, Abingdon Health, Alivecor, Aptargroup, Ares Genetics, Avricore Health, Avrok Laboratories, Beyond Air, Bioiq, Biomicrolab, Butterfly Network, C2dx, Coopersurgical, Eagleforce Health, Ers Genomics, Eurofins, Fulgent Genetics, Gauss, Greenbioaz, Halberd, Kroger, Lifelabs, Longview, Machine Sense, Medtronic, Meridian Biosciences, Microbix Biosystems, Multiplex Genomics, Myomo, Oneworld Accuracy, Patchai, Progressive Care, Roche, Spt Labtech, Stryker, Theranica, Virtus Health, Xphyto Therapeutics, Zeclinics. Read More

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Electrocore, Front Line Medical Technologies, Insightec, Luminostics, Saladax, Shockwave Medical, Smart Medical. Read More

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Shuren, Stenzel push back on serology tests; FDA touts accomplishments for 2020; IMDRF posts five-year plan. Read More

Keeping you up to date on recent developments in oncology, including: CD161 identified as impediment to immune response in diffuse glioma; iPSCs give sneak preview of AML; A role for chloroquine in cancer; Fecal transplant may aid in response to immunotherapy in melanoma. Read More