Dive Brief: Abbott said Tuesday it won a breakthrough device designation for a fully implantable left ventricular assist device (LVAD), which could help speed the experimental technology through FDA review. The devices are intended for use in people with advanced…
Abiomed, on defense, plans wave of trials to counter Impella criticism
Dive Brief: Abiomed on Thursday outlined plans to start a “wave of clinical studies” to counter research papers suggesting its Impella heart pump is more expensive and dangerous than alternatives. The two large observational studies presented at a medical meeting…
Verily plans digital ophthalmology joint venture with Santen
Verily is planning a digital ophthalmology joint venture with Japan’s specialist in the field, Santen. The joint venture does not yet have a name but aims to use machine learning and artificial intelligence techniques, as well as connected and integrated…
New Clinical Trial Models Make Studies An Option For More People
The advent of precision medicine, marked by the need to recruit relatively rare cohorts of patients into studies, has ignited interest in new, more efficient models of clinical development ranging from “just-in-time” rapid enrollment to trials requiring no sites at all, according to Gaurav Singal, chief data…
FDA and NIH let clinical trial sponsors keep results secret and break the law
For 20 years, the U.S. government has urged companies, universities, and other institutions that conduct clinical trials to record their results in a federal database, so doctors and patients can see whether new treatments are safe and effective. Few trial…
Janssen, Apple Launch Virtual Randomized Heart Trial For Atrial fibrillation (AFib)
A virtual randomized trial launching this month will investigate whether a collaboration between a new heart health app, a medication adherence program, and an Apple Watch can accelerate the diagnosis of cardiovascular events, increase healthful lifestyles, and decrease strokes and…
Smith & Nephew acquires Tusker’s PMA-winning ear infection device for ENT portfolio
Dive Brief: Smith & Nephew said Friday it acquired Tusker Medical, which two months ago achieved FDA premarket approval for a treatment designed for children or adults with recurrent ear infections. The Menlo Park, California-based medtech developed the Tula System,…
GE cybersecurity flaw gets maximum risk score, triggering rare FDA notice
Dive Brief: FDA has issued a notice about cybersecurity vulnerabilities affecting GE Healthcare Clinical Information Central Stations and Telemetry Servers. The vulnerability scored 10 out of 10 on a risk scale outlined in a Department of Homeland Security notice flagging…
3 more notified bodies coming soon, EC says as MDR clock ticks down
Dive Brief: The European Commission in an update this week said three more notified bodies have made it to the final stage of certification under incoming medtech rules in the EU and are awaiting official publication in the NANDO database. The relatively…
UK biotech Quench targets lupus and rare diseases with R&D into new drug class
UK biotech Quench Bio has emerged from stealth mode with $50 million of committed funding, bidding to be the first company to target Gasdermin D (GSDMD) in inflammatory disease indications poorly served by existing drugs. This protein and others in…
