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BioWorld - Friday, September 29, 2023
Home » Topics » Cardiovascular, BioWorld MedTech

Cardiovascular, BioWorld MedTech
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Flag of Australia, sky background

TGA eyes revamp of regulations for devices with biological tissues

July 24, 2023
By Mark McCarty
No Comments
Australia’s Therapeutic Goods Administration (TGA) is reconsidering its approach to regulating devices that bear materials of animal, microbial or recombinant origin, a broad class of products that includes transcatheter aortic valve replacement (TAVR) devices.
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Heart and lungs

Magassist moves forward with ECMO in China's heart failure market

July 21, 2023
By Doris Yu
No Comments
Taking a step forward in an increasingly crowded market that has long been dominated by non-Chinese players, Magassist Co. Ltd. got positive clinical results from its extracorporeal membrane oxygenation (ECMO) system Breathmo to provide support for patients with serious heart failure or lung failure, with a study showing that the system can provide pulmonary and cardiac support effectively and safely.
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Quidel, Medtronic hit with class I recalls

July 18, 2023
By Mark McCarty
No Comments
Recalls are a fact of life in the medical technology space, and Medtronic plc and Quidel Cardiovascular Inc., have both been forced to report class I recalls. Dublin-based Medtronic announced a recall of more than 348,000 cardiac electrophysiology devices due to issues that could prevent high-voltage therapy while San Diego-based Quidel is recalling nearly 7,800 Triage cardiac panels because of a risk of false negatives for patients being assessed for an infarct.
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Shineco’s cardiac test approved in China for acute myocardial infarction

July 18, 2023
By Doris Yu
No Comments
Shineco Inc.’s subsidiary Changzhou Biowin Pharma received marketing approval from China’s NMPA for its test device that can complete a diagnosis of acute myocardial infarction in five minutes. The five-minute cardiac test relies on a combination of three major cardiac markers that can detect cardiac troponin I, myoglobin and heart fatty acid binding protein in a single test.
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Caristo demonstration image

Caristo deploys Cari-Heart imagining technology in NHS pilot

July 17, 2023
By Shani Alexander
No Comments
Caristo Diagnostics Ltd. is deploying its medical imaging technology, Cari-Heart, at several NHS hospitals in a pilot project that will help identify patients at risk of heart attack years before it occurs. Cari-Heart detects signs of inflammation around coronary arteries. “No other company is doing this,” Frank Cheng, CEO of Caristo told BioWorld. “No one is using CT to quantify and visualize coronary inflammation” to predict the risk of a heart attack years in advance.
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Iron bioresorbable scaffold

Lifetech Scientific releases positive data of bioresorbable scaffold

July 14, 2023
By Doris Yu
No Comments
Lifetech Scientific Corp.’s fully degradable iron-based absorbable coronary scaffold showed its safety and efficacy to treat non-complex coronary lesions that have not been previously treated with an interventional device during a three-year, first-in-humans trial.
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Silk Road Medical may take a hit in new US Medicare draft for carotid artery stenting

July 13, 2023
By Mark McCarty
No Comments
The U.S. CMS is proposing to expand coverage of angioplasty and stenting for the carotid arteries to include patients who currently cannot receive this treatment for carotid artery stenosis outside of a clinical trial, generally a cause for celebration among device makers. However, Silk Road Medical Inc. is one possible exception to the overall picture as utilization of its transcarotid artery revascularization (TCAR) system may suffer as a result.
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Artery and plaque

FDA concedes the argument regarding paclitaxel mortality

July 11, 2023
By Mark McCarty
No Comments
Five long years after the publication of the now-notorious Katsanos paper, the U.S. FDA has issued a final determination about whether devices indicated for treatment of peripheral artery disease carry the threat of excess mortality when using paclitaxel as an antiproliferative.
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Woman using Parasym's neuromodulation technology

Parasym’s neuromodulation tech a breakthrough for people with postural tachycardia syndrome

July 10, 2023
By Shani Alexander
No Comments
Parasym Ltd.’s neuromodulation technology significantly decreased postural tachycardia syndrome (POTS) and has the potential to be a safe and effective treatment for individuals living with the condition, according to a recent study. The result from the trial represents a substantial breakthrough for people with POTS, as there are no U.S. FDA approved treatments for the condition, Nathan Dundovic, co-founder at Parasym, told BioWorld.
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Sinotau Pharmaceutical Groups office

Sinotau nets $152M in financing to develop radiopharmaceuticals in China

July 5, 2023
By Doris Yu
No Comments
Sinotau Pharmaceutical Group raised ¥1.1 billion (US$152 million) in a financing round to develop its radiopharmaceutical drugs for diagnostic and therapeutic interventions.
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