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FDA is modernizing its 510(k) program and one change it is mulling is placing a limit on how old a predicate device is when manufacturers develop a new product showing substantial equivalence. Source link
dna, genomics
An oncologist compared NTRK fusion patients to a needle in a haystack, but had some clues of how to find them. Still, drugs like Vitrakvi call for genomic sequencing of all cancer patients, he said. Source link
money, dollar
Jump Technologies, a supply chain solutions provider, has secured $2 million in follow-on Series B funding, which it will use to expand its sales efforts and support product development. Black Granite Capital led the round. Mount Sinai Ventures also participated, as did two unnamed previous investors in the company. The $2.2...
Shot of a businesswoman using technology at work
The patient experience doesn’t end after an individual leaves their physician’s office. But oftentimes, healthcare facilities don’t have a digital way to quickly and accurately gather feedback from patients once they go home. That’s where Rivews, a startup based in New York City, comes in. Founded in 2016, the...
Close Up of Illuminated Glowing Keys on a Black Keyboard Spelling Data Breach 3d illustration
Healthcare organizations are learning tough lessons that actions of employees can come back with serious consequences to the organization. When it comes to maintaining the privacy and security of patient data, no action comes without consequences. While some actions are completely uncontrollable, that does not necessarily mean that...
NVIDIA, often considered one of the major companies helping to drive the rapid development of AI technology through its line of GPU-based hardware and associated software products, is pushing heavily into the field of AI-assisted radiology. The company is expanding its Clara Platform which allows users to utilize virtual super computing...
A drugmaker developing therapies for metabolic diseases suffered its second major regulatory setback in three years as the Food and Drug Administration placed a hold on its lead drug candidate before it had even left the gates for clinical testing. Boston-based Zafgen said Monday the FDA had sent it...
Savvy Cooperative won the MedCity News ENGAGE Pitch Perfect 2019 contest. From left: Michael Pellini of Section 32; Arundhati Parmar of MedCity News; Jen Horonjeff of Savvy Cooperative; and John Mattison of Kaiser Permanente. More and more, drug developers, medtech and digital health companies style themselves as patient-centered or...
telehealth, telemedicine, doctor, computer, physician
Boston Children’s Hospital and 2nd.MD, a telehealth startup, have initiated a strategic partnership focused on pediatric telemedicine. The alliance will rely on 2nd.MD’s technology and employer and health plan network to give patients across the nation virtual access to doctors from Boston Children’s. Overall, 2nd.MD’s members can get video consultations...
EU Commission President Jean-Claude Juncker and UK Prime Minister Theresa May during a meeting at the EU headquarters in Brussels, Nov. 21, 2018 The head of the UK’s regulatory agency for health products plans to step down next fall, citing the country’s withdrawal from the European Union as a...
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