The U.S. FDA has given its nod to Abbott Laboratories' next-generation Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. The Gallant system pairs with Abbott's secure Mymerlinpulse, an iOS- and Android-compatible mobile smartphone app that aims to streamline communication between doctors and their patients. Read More
The comment period has closed on the U.S. FDA’s discussion draft for artificial intelligence (AI) in medical devices, a paper that attracted the attention of medical societies and regulated industry. One of the questions posed by industry was whether the FDA is in a position to deal with the massive volumes of data developers would have to disclose to the agency, creating concern that such disclosures would amount to little more than an obligatory and useless data dump. Read More
A large epidemiological study published in the July 6, 2020, advance online issue of The Lancet found that most individuals who became infected with SARS-CoV-2 developed antibodies to the virus, confirming that infection usually results in at least a short-term immune response. Read More
Elucid Bioimaging Inc.'s Vascucap artificial intelligence-based software analyzes CT angiograms (CTA) to characterize and quantify atherosclerotic plaque to predict a patient’s stroke risk. Read More
Mastor SAS secured €3 million (US$3.39 million) in seed investment from Sofinnova Partners' MD Start III Fund and €1.9 million in non-dilutive funding through the i-Nov Innovation Award from BPI France, the French national public investment bank. Read More
PARIS – Quantum Surgical SAS said it has achieved a world first at the Montpellier University Hospitals by successfully using its medical robot to perform surgery on three patients with liver cancer. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Endologix, Hitachi, Hoya, Medtronic, Myriad Genetics, Nuvera Medical, Sino Medical Science Technology, Vizient. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, BD, Centogene, Cochlear, Inmode. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Aetna, Arrow International, BD, Erba Diagnostics, Eternity Healthcare. Read More
Keeping you up to date on recent developments in cardiology, including: Potassium channel distancing fights stroke; Examining ischemic stroke in patients with COVID-19 vs. those with influenza; COVID-19 infects heart cells in lab dish. Read More
