Sensome today announced positive results from two studies of its Clotlid smart guidewire system for identifying blood clots. Outcomes highlighted Clotlid's ability to successfully identify "fresh" clot — thrombus rich in red blood cells (RBCs) — in peripheral artery disease (PAD) and differentiate it from other tissue encountered during PAD … [Read more...] about Sensome data supports clot-sensing guidewire
Technologies & Devices
Vantis Vascular closes $10M Series B
Vantis Vascular announced today that it successfully closed a Series B-1 preferred financing round worth $10 million. San Jose, California-based Vantis' latest funding brings the company to $30 million raised to date. The company develops the CrossFast microcatheter guide extension system along with the CrossShock intravascular lithotripsy (IVL) … [Read more...] about Vantis Vascular closes $10M Series B
Pentax wins FDA nod for new models of endoscopes
Pentax Medical announced today that it earned FDA 510(k) clearance for new models of its i20c video endoscope series. The new models — the Video Colonoscope EC34-i20cL, Video Upper GI Scope EG27‑i20c and Right/Left Wheel Extender OE-B17 — work in combination with the Pentax Medical Inspira Video Processor EPK-i8020c. They support healthcare … [Read more...] about Pentax wins FDA nod for new models of endoscopes
Second Heart Assist concludes mechanical circulatory support trial
Second Heart Assist announced today that it completed the third in a planned series of studies for its mechanical circulatory support device. Whisper, a catheter-based, minimally invasive device, utilizes a stent cage fitted with a motorized impeller. It aids in providing circulatory support throughout a patient’s body. The system is intended … [Read more...] about Second Heart Assist concludes mechanical circulatory support trial
Anteris Technologies launches IPO to support heart valve technology
Anteris Technologies today announced the launch of its initial public offering in the U.S. The company aims to raise funds through the IPO to advance the development of its DurAVR transcatheter heart valve technology. Anteris’ IPO consists of 14.8 million shares of common stock, with an additional 2.22 million shares available to underwriters … [Read more...] about Anteris Technologies launches IPO to support heart valve technology
Stereotaxis wins approval in China for magnetic ablation catheter
Stereotaxis (NYSE:STXS) announced today that its Magbot magnetic navigation ablation catheter received regulatory approval in China. This nod comes just weeks after the company won approval from China’s National Medical Products Administration for the Genesis robotic magnetic navigation (RNM) system. St. Louis, Missouri-based Stereotaxis aims to … [Read more...] about Stereotaxis wins approval in China for magnetic ablation catheter
Lungpacer Medical wins FDA premarket approval for AeroPace neurostim system
Lungpacer Medical announced that it received FDA premarket approval for its flagship AeroPace neurostimulation system. AeroPace uses neurostimulation via an electrode-containing cardiovascular catheter and a software-controlled system. It delivers periodic phrenic nerve stimulation through the venous catheter. The system contracts and … [Read more...] about Lungpacer Medical wins FDA premarket approval for AeroPace neurostim system
FDA grants breakthrough nod to pulsed field ablation tech from Farapulse founder’s Field Medical
Field Medical announced today that it received FDA breakthrough device designation for its FieldForce pulsed field ablation (PFA) system. The FDA also accepted the technology into its Total Product Lifecycle Advisory Program (TAP). TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates … [Read more...] about FDA grants breakthrough nod to pulsed field ablation tech from Farapulse founder’s Field Medical
Terumo launches R2P NaviCross peripheral support catheter in US
Terumo is further boosting its radial-to-peripheral portfolio with the U.S. launch of its R2P NaviCross peripheral support catheter. The Japanese medtech giant's Terumo Interventional Systems division designed the R2P NaviCross catheter for optimized performance in R2P procedures, which involve accessing the radial artery around the wrist in … [Read more...] about Terumo launches R2P NaviCross peripheral support catheter in US
First U.S. cases performed with Medtronic Affera ablation system
A hospital in Texas announced today that its electrophysiologists completed the first U.S. cases with the Medtronic (NYSE:MDT) Affera platform. EPs at the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center performed the procedures with Affera. Dr. Andrea Natale and Dr. Amin Al-Ahmad conducted the first procedure on Nov. 7. A … [Read more...] about First U.S. cases performed with Medtronic Affera ablation system
