Abbott Laboratories reported the U.S. FDA approval of a new device specifically designed for the repair of leaky tricuspid heart valves. The Triclip was granted a PMA for the treatment of tricuspid regurgitation following the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention that the benefits of Triclip outweighed the risks.
Exact Sciences Corp. reported on data showing high sensitivity and specificity for the non-endoscopic Oncoguard Esophagus test that is currently in development for the detection of esophageal adenocarcinoma (EAC) and its precursors, including Barrett’s esophagus.
In its first full year since its spin-off from parent company General Electric Co., GE Healthcare Technologies Inc. reported beating Wall Street’s expectations. For 2023, revenues of $19.6 billion grew 8% organically vs. 2022.
Edwards Lifesciences Corp. received some good news with the earlier-than-expected U.S. FDA approval of its Evoque tricuspid valve replacement system. The company beat out rival Abbott Laboratories for the honor of being the first transcatheter therapy to receive FDA approval.
In the latest salvo of the ongoing battle between Apple Inc. and Masimo Corp. over the use of a blood oxygen technology, a U.S. federal appeals court paused an International Trade Commission (ITC) ban on Apple’s watches. Apple reported on Dec. 19 that it would pull the Apple Watch Ultra 2 and Apple Watch Series 9 from its website on Dec. 21 and from its retail locations after Dec. 24, in response to an exclusion order issued by the ITC in October.
The Securities and Exchange Commission (SEC) charged Laura Tyler Perryman, the former CEO and co-founder of Stimwave Technologies Inc., with defrauding investors out of approximately $41 million by making false and misleading statements about one of the company’s products. According to the SEC’s complaint, the Stimwave device comprised several components, one of which was a fake, non-functional component that was implanted into patients’ bodies.
The U.S. FDA opted not to pursue one form of medical device harmonization via the Global Harmonization Working Party (GHWP), as it reported it will withdraw from the organization.
Philips Respironics Inc.’s nightmares with its Dreamstation continuous positive airway pressure (CPAP) line of products continued with a fresh warning from the U.S. FDA of reports involving thermal issues with a newer iteration of the machine, some of which cited patient injuries.
The time to diagnosis of sepsis infection to a patient in the hospital can be critical, with underdiagnosis resulting in rapid deterioration, risk of organ damage and need for readmission, and overdiagnosis leading to the avoidable and sometimes serious health consequences of overtreating patients with broad-spectrum antibiotics.
In a new report from the U.S. International Trade Commission (USITC), concerns about global inequities accessing diagnostics and medicines for COVID-19 reveal that there are varied and divergent opinions on whether the intellectual property (IP) protections that support the development of new medicines may also act as a barrier to access, particularly in developing countries. In December 2022, U.S. Trade Representative Katherine Tai asked the USITC to respond and identify significant data and information gaps.