medical device guru

Cardiovascular / Cardiology
Massive Medtronic Pacemaker Recall is Class I Says FDA
The FDA has slapped the most serious designation on a recall of approximately 156,957 Medtronic dual-chamber pacemakers. The Fridley, Minn.-based company issued a recall in January on pacemakers with model names Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron due to a software error that can...
February 18, 2019
Cardiovascular / Cardiology
Itamar Medical Gets Favorable CMS Reimbursement Decision for WatchPAT Technology
Itamar Medical Ltd. today announced the release of the 2019 Fee Schedule from the U.S. Centers for Medicare & Medicaid Services (CMS) that should support broad use of its WatchPAT technology. WatchPAT is the only product on the market today...
November 9, 2018
Cardiovascular / Cardiology
Cardiawave raises $8.2 million for non-invasive aortic stenosis device
Parisian startup Cardiawave has raised more than $8 million to boost development of its ultrasound device to treat calcific aortic stenosis. Nearly $3 million came from the European program Instrument PME, which finances disruptive European technologies developed by potentially high-growth companies. Family-controlled...
September 28, 2018
Cardiovascular / Cardiology
People who walk just 35 minutes a day may have less severe strokes
People who participate in light to moderate physical activity, such as walking at least four hours a week or swimming two to three hours a week, may have less severe strokes than people who are physically inactive, according to a...
September 20, 2018
Cardiovascular / Cardiology
New Apple Watch Will Have Built-In ECG, and It’s Already FDA Approved
At Apple’s annual September hardware launch event, Apple revealed a major medical advancement added to their newest update in the Apple Watch line: the Apple Watch Series 4. Among other updates including a larger screen and smaller bezel, the system...
September 12, 2018
Cardiovascular / Cardiology
FDA Issues Warning Letters to Medtronic CRM Plants in Puerto Rico, Minnesota
The US Food and Drug Administration (FDA) issued two warning letters to Medtronic on Tuesday related to manufacturing nonconformities that resulted in a defibrillator recall earlier this year. The recall of the Medtronic Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and...
September 12, 2018
Cardiovascular / Cardiology
Revolution in Electrocardiography Long in Coming, but MyoVista Fills the Bill
“Revolutionary!” and “Transformative!” are tossed around like so much jetsam in today’s spotlight-driven culture, and the medical field is not immune. But we believe a product that harvests multiple indicators of heart disease from a simple, inexpensive, first-line test has...
August 28, 2018
Cardiovascular / Cardiology
Vascular Changes after Smoking Hookah on par with Cigarettes
Smoking hookah for 30 minutes causes changes in arterial stiffness similar to what’s seen after someone smokes a cigarette, according to a study published in the American Journal of Cardiology. “Our findings challenge the concept that fruit-flavored hookah tobacco smoking is a healthier...
August 24, 2018
Cardiovascular / Cardiology
BioSig’s High-Fidelity Electrophysiology System Approved by FDA
BioSig Technologies, Inc. announced that the Company has received 510(k) clearance for its first product, PURE EP System, from the U.S. Food and Drug Administration (FDA). The non-invasive PURE EP System is a computerized system intended for acquiring, digitizing, amplifying,...
August 14, 2018
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