Cardiology News Alerts

• Alert Dabigatran Antidote Praxbind Picks Up Full FDA Approval Granted accelerated approval in 2015, the company now has received full FDA approval for idarucizumab to reverse the effects of dabigatran.
  FDA Approvals, April 2018
• Alert FDA OKs Firmware Update for ICD, CRT-D Battery, Security Glitches The FDA-approved update for the defibrillator implants from Abbott, formerly St Jude Medical, separately addresses previously identified cybersecurity and battery-depletion issues.
  News Alerts, April 2018
• Alert FDA OKs ASD Device for PFO Closure to Prevent Recurrent Stroke
  FDA Approvals, April 2018
• Alert FDA Clears World's Smallest Mechanical Heart Valve Expanded approval for Abbott’s Masters Series 15-mm heart valve fills an unmet need in newborns and infants with heart defects, who may be too small for currently available valves, the FDA says.
  FDA Approvals, March 2018
• Alert FDA: Class I Recall of 48 Medtronic ICDs, CRT-Ds Clinicians received serial numbers in January and were asked to consider replacement of the affected devices, said to have a manufacturing defect that might prevent shock or pacing therapy.
  News Alerts, February 2018
• Alert FDA Approves First 2.0-mm Drug-Eluting Stent in US The approval taps into a patient population with an unmet clinical need and expands Medtronic's device platform from sizes 2.0 mm to 5.0 mm.
  FDA Approvals, February 2018
• Alert FDA Alert: Clarithromycin Risky in Patients With Heart Disease The agency adds a new warning about the increased risk for death in patients with heart disease prescribed the antibiotic clarithromycin and recommends considering an alternative when possible.
  News Alerts, February 2018
• Alert FDA Expands Impella Pump Indications in High-Risk PCI, Shock The catheter-delivered temporary ventricular support pumps are now indicated for high-risk PCI regardless of LV function, and for shock secondary to cardiomyopathy, Abiomed announced.
  FDA Approvals, February 2018
• Alert Influenza Hospitalizations Highest on Record, CDC Says Overall hospitalizations for influenza-like illness are at their highest since the CDC began collecting such data, and the season has yet to peak, according to new government information.
  News Alerts, February 2018
• Alert FDA Acts to Stem Misuse, Abuse of Antidiarrheal Loperamide The FDA moves to limit the number of loperamide doses per package amid ongoing reports of serious cardiac problems and deaths with misuse and abuse of the antidiarrhea medication.
  News Alerts, January 2018
• Alert CDC Says Influenza Activity as Widespread as 2009 Pandemic The agency said baby boomers now have the second-highest hospitalization rate, and the pediatric death rate is especially alarming.
  News Alerts, January 2018
• Alert FDA Safety Alert Issued for Zoll LifeVest Wearable Defibrillator The FDA says the device may fail to delivery therapy if a certain message code is displayed, one that says only that the device might need servicing.
  News Alerts, January 2018
• Alert Trump's Doctor Says Health Excellent, Attributes 'Good Genes' Along with his overall health the president had a perfect score on the MoCA test, showing excellent cognitive health, said the White House physician.
  Medscape Medical News, January 2018
• Alert Trump Said to Be in 'Excellent Health' After Annual Physical The full details of the president's first physical will be released January 16.
  Medscape Medical News, January 2018
• Alert Edwards Lifesciences Recalls Certitude Delivery System
  News Alerts, January 2018
• Alert Clopidogrel Tablets Recalled, May Contain Simvastatin International Laboratories issued the recall because the tablets, labeled as clopidogrel 75 mg, may contain the cholesterol-lowering drug simvastatin, an FDA safety alert notes.
  News Alerts, January 2018
• Alert Pneumothorax Events Linked to Placement of Enteral Feeding Tube The FDA has received 79 reports (including 17 deaths) of pneumothorax events associated with feeding tube placement involving two approved enteral access systems.
  News Alerts, January 2018
• Alert Little Blue Pill Goes Generic Today, and Pfizer Joins In Pfizer will offer its own generic version of Viagra, to compete with the first generic version of the drug brought to market today by Teva after years of patent battles.
  FDA Approvals, December 2017
• Alert FDA Approves Semaglutide for Type 2 Diabetes The once-weekly GLP-1 agonist joins a crowded field, but may offer advantages over competitors.
  FDA Approvals, December 2017
• Alert FDA Approves Evolocumab (Repatha) to Prevent CV Events Evolocumab becomes the first PCSK9 inhibitor approved in the US to reduce outcomes including MI, stroke, and coronary revascularization, as well as lipid lowering.
  FDA Approvals, December 2017