DePuy Synthes’ Teligen System Cleared October 24, 2022 The company expects the system to be available in the U.S. later this year. Read More
Genetica+ Gets CE-IVD Mark for Blood Test for Depression Treatments October 21, 2022 In a recent 12-week study, the test demonstrated “unprecedented accuracy” in predicting drug response, the company said. Read More
FDA Grants De Novo Authorization to BrainCool’s Cooral System October 21, 2022 The Cooral System received Breakthrough Device designation in 2021. Read More
Sol Millennium Gets 510(k) Clearance for Blood Collection Set October 21, 2022 The company believes this device will improve the blood collection experience for both clinicians and patients. Read More
FDA Grants 510(k) Clearance for 3D LifePrints’ EmbedMed October 20, 2022 EmbedMed can also be used as a pre-operative software tool to simulate surgery and evaluate surgical planning, the company said. Read More
Acutus Submits Premarket Approval Application for AcQBlate Force October 20, 2022 The catheter and system are being evaluated in an ongoing clinical trial in patients with right atrial typical flutter. Read More
IceCure Submits De Novo Classification Request for ProSense System October 19, 2022 Israel-based IceCure Medical has submitted a De Novo classification request to the FDA for its ProSense liquid nitrogen cryoablation system. Read More
HeartFlow’s Two AI Tools Gain FDA Clearance October 19, 2022 The company plans to offer the two AI-based tools for use in hospitals and health systems. Read More
FDA Expands Approval of Medtronic’s Cardiac Pacing Lead October 19, 2022 The lead is now approved for use as an alternative to right ventricular pacing. Read More
Ulrich Medical Gets 510(k) Clearance for Flux-C October 19, 2022 The interbodies are available in multiple sizes and curved options to allow for the patient’s individual anatomy. Read More
Abiomed’s Impella Low Profile Sheath Cleared October 18, 2022 Abiomed plans a phased U.S. rollout of the device in the current quarter. Read More
Roche’s COVID-19 Rapid Tests Gain CE Marks October 17, 2022 The company plans European distribution of the new rapid tests within weeks. Read More