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Interim study supports Vectorious LAP-guided patient self-management
Vectorious Medical Technologies today announced interim results from a pilot study of its V-LAP sensor for heart failure management. Tel Aviv, Israel-based Vectorious presented results from the left atrial pressure (LAP) guided patient self-management study at during an abstract session at THT 2023 in Boston. The study has 13 enrolled patients to date. It includes […]
NuVasive misses overall estimates on Wall Street
Nuvasive (Nasdaq:NUVA) this week posted fourth-quarter results that missed overall estimates on Wall Street. The San Diego-based orthopedic company reported profits of $24.1 million, or 42¢ per share, on sales of $305.5 million, for the three months ended Dec. 31, 2022, on sales growth of 1.12% compared to Q4 2021. It also had a profit […]
Supreme Court denies J&J appeal of $302M vaginal mesh ruling
The U.S. Supreme Court today declined to hear Johnson & Johnson‘s (NYSE:JNJ) appeal of a $302 million judgment for false and deceptive marketing of its vaginal mesh implants. The nation’s highest court denied the medtech maker’s bid for review without comment, allowing the California ruling to stand. Attorneys for the state sued Johnson & Johnson […]
FDA expands access to BioVentrix ischemic heart failure treatment
BioVentrix announced today that it received FDA approval for its application for an expanded access program for the Revivent TC system. San Ramon, California-based BioVentrix designed the Revivent TC system to support a minimally invasive heart procedure. It treats a dilated left ventricle of patients with ischemic heart failure. They also have reduced ejection fraction […]
Titan Medical meets with strategic buyers and investors as surgical robot developer considers its future
Titan Medical (Nasdaq:TMDI) met with potential buyers of the surgical robotics company this week in San Francisco. The Toronto-based medical device developer has been considering the best options for investors and the company’s Enos surgical robot. Facing delisting of its stock from the Nasdaq exchange due to its low price last year, Titan Medical announced […]
FDA hits Olympus with warning letters after factory inspections
The FDA today released warning letters against Olympus Medical Systems Corp. and Olympus Corp. subsidiary Aizu Olympus following inspections of their endoscope and reprocessor manufacturing facilities. The warning letters allege medical device reporting (MDR) and quality system violations at the manufacturing operations. “Olympus’ highest priority is providing patients and users with safe and effective medical […]
Minerva Surgical CEO retires, former Activ Surgical head Todd Usen named as replacement
Minerva Surgical (Nasdaq:UTRS) announced that it appointed Todd Usen to replace retiring President and CEO David Clapper. Clapper served as president and CEO of the abnormal uterine bleeding (AUB) treatment developer since 2011. Minerva selected Former Activ Surgical CEO Todd Usen to take over those roles and become a member of the board, effective Jan. […]
DeviceTalks Weekly: What’s your top story of 2022?
DeviceTalks Weekly is inviting listeners to record their personal picks for top medtech story of 2022. It’s easy! Step 1 — Make sure you’re on a device with a good microphone. Phones work great! Step 2 — Click here. This will open a new window. Step 3 — Open up by giving us you name, […]
Medtronic RDN trial fails to beat hypertension drugs; data submitted for FDA review
Medtronic (NYSE:MDT) said its Symplicity Spyral renal denervation (RDN) system for treating hypertension failed to outperform blood pressure drugs in the latest trial results. However, the SPYRAL HTN-ON MED clinical trial’s six-month results did show improvement over Medtronic’s previous RDN efforts, the device maker said in a news release. RDN is designed to treat hypertension […]
Levita Magnetics raises $26M for Magnetic-Assisted Robotic Surgery platform
Levita Magnetics said today it has raised $26 million to fund regulatory and commercial progress on its Magnetic-Assisted Robotic Surgery (MARS) platform. The Menlo Park, California-based robotic surgery system developer also appointed Maria Sainz as chair of its board of directors. The MARS platform is designed to help surgeons perform more high-volume abdominal procedures using […]