Tag: FDA

GSK’s Covid-19 Valentine to Vir Biotech: ‘You Can Go Your Own Way’

GSK’s Covid-19 Valentine to Vir Biotech: ‘You Can Go Your Own Way’

MedCity News

Vir Biotechnology’s Covid-19 research may yield more drugs and perhaps a vaccine, but no longer with the financial support of GSK. The collaboration agreement the two companies struck up in the early days of the pandemic has been amended, leaving Vir to either find another partner or continue its coronavirus research on its own.
The alliance did successfully develop the Covid-19 drug sotrovimab. GSK and Vir will continue to share responsibilities for that drug, which is available under the brand name Xevudy in more than 40 countries. The U.S. is no longer one of them. Last April, the FDA withdrew emergency authorization…

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Adverse Survival Signal Leads G1 to Stop Pivotal Test in Colorectal Cancer

Adverse Survival Signal Leads G1 to Stop Pivotal Test in Colorectal Cancer

MedCity News

G1 Therapeutics’ approach to cancer does not kill tumors. Instead, the biotech’s drug, trilaciclib, protects bone marrow from the damaging effects of chemotherapy, reducing the duration and severity of the problems that can limit the use of this cancer treatment. Since trilaciclib’s initial approval insmall cell lung cancer, G1 has pursued more clinical trials that could support expanding the drug to other cancers. Colorectal cancer will no longer be one of them.
On Monday, G1 reported preliminary data showing that the placebo group outperformed the trilaciclib arm in helping patients live longer. G1 said it has decided to stop the colorectal cancer…

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CDS Coalition requests FDA rescind final decision support guidance

CDS Coalition requests FDA rescind final decision support guidance

Healthcare IT news

The CDS Coalition is asking the U.S. Food and Drug Administration to pull back on its clinical decision support guidance in order to ensure that the agency better balances its regulatory oversight with the healthcare sector’s need for innovation, while comporting with the statutory language of the 21st Century Cures Act. ‘Flagrant’ disregard for Congressional law and intent
The coalition’s stakeholders – clinical decision support software developers, patient advocacy organizations, clinical societies, healthcare providers and healthcare payers – say the FDA’s guidance exceeds Congress’s statutory definitions of what is considered CDS and threatens to undermine lawmakers’ goals.
“The Office of the National Coordinator for…

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FDA approves AI ultrasound application for musculoskeletal imaging

FDA approves AI ultrasound application for musculoskeletal imaging

Healthcare IT news

Clarius Mobile Health, which first introduced wireless handheld imaging for medical specialties in 2016, says its third-generation device, HD3, which was approved by the U.S. Food and Drug Administration this week, will also help improve MSK ultrasound training.WHY IT MATTERS
With clearance from the FDA, the new MSK AI model will be available with the Clarius L7 HD3 and Clarius L15 HD3 ultrasound scanners introduced last year, according to the announcement.
“AI automation is the new frontier and we’re excited to be the world’s first to receive FDA clearance to use AI for musculoskeletal ultrasound,” said Ohad Arazi, president and CEO, in the statement.
Upon…

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Microsoft signs first AI healthcare partnership in Vietnam

Microsoft signs first AI healthcare partnership in Vietnam

Healthcare IT news

AI healthcare software company VinBrain, a company backed by Vietnam’s largest conglomerate Vingroup, has entered into a formal collaboration with Microsoft.WHAT IT’S ABOUT
According to a press release, the partnership, which is a first for the global tech company in Vietnam, will work on three areas of AI healthcare: data sharing, cross-product validation, and R&D.
VinBrain will leverage DrAid, its suite of AI-powered pathology solutions which can detect 21 disease indicators of the heart, lungs and bone. The US FDA-approved platform is being used by around 2,000 doctors and more than 100 hospitals in Vietnam. 
The AI platform runs on a dataset of over…

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Remote therapeutic monitoring is reimbursable – here's what you need to know

Remote therapeutic monitoring is reimbursable – here’s what you need to know

Healthcare IT news

Ever since CMS released the new CPT codes for remote therapeutic monitoring last year, health systems have been eager to use them, but unsure of the criteria. Providers are acknowledged for the time they spend connecting with patients outside of the office.With the new CPT codes, providers can get reimbursed for:

Educating patients on how to use a remote care-management platform.

Monitoring a platform’s alerts and patients’ use of remote education.

Direct patient/provider messaging within the platform.

Data collection via the platform, i.e., collecting patient feedback on pain levels, activity and motion.

To qualify for reimbursable RTM, providers need to use software deemed a medical device…

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What are Regulatory Compliances for #Healthcare #Products? || EMed #HealthTech

What are Regulatory Compliances for #Healthcare #Products? || EMed #HealthTech

EMed HealthTech

As in every industry, the healthcare industry is also ruled by certain regulations that determine what is legal and illegal. Every country has certain regulations the healthcare industry needs to follow while implementing healthcare #software #solutions. Here are 6 major healthcare #regulations :1. Health Insurance Portability and Accountability Act #HIPAA -…

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Vendor Notebook: new tools and acquisitions from OptumRx, ScionHealth, others

Vendor Notebook: new tools and acquisitions from OptumRx, ScionHealth, others

Healthcare IT news

It’s a new year, and healthcare technology vendors are rolling out their latest innovations, market approvals, acquisitions and staffing shake-ups.OptumRx launched Price Edge, a tool that compares pricing for traditional generic drugs to ensure members get the lowest prescription drug prices. A suite of new tools for both patients and providers target aspects of pharmacy logistics that have been known to delay or complicate care, such as getting real-time pharmacy benefits information and obtaining prior authorizations. In October, Optum, UnitedHealth Group’s pharmacy services company, merged with data clearinghouse Change Healthcare. The U.S. Department of Justice tried to block the merger and is appealing the…

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