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FDA| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant

Scanwell Health’s FDA-Cleared, Smartphone-Enabled UTI Test Kit Now Available at Amazon

by Jasmine Pennic 12/10/2020 Leave a Comment

Scanwell Health’s FDA-Cleared, Smartphone-Enabled UTI Test Kit Now Available at Amazon

What You Should Know: - LA-based Scanwell Health announced today that its at-home UTI test kits - featuring the first FDA-cleared urinalysis app that lets people test for a UTI without having to visit a lab or doctor - is now available on Amazon.com. - The kits are priced at 3 for $15. Happy to send a graphic or answer any questions you have. Until now, the kits have been available only directly through the Scanwell Health web site. - Scanwell enables clinical-grade testing, instant
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Freespira Secures $10M for FDA-Cleared Digital Therapeutic to Eliminate Panic Attacks, PTSD Symptoms

by Jasmine Pennic 12/09/2020 Leave a Comment

Freespira Secures $10M for FDA-Cleared Digital Therapeutic to Eliminate Panic Attacks, PTSD Symptoms

What You Should Know: - Lightspeed Venture Partners, the VC behind Nest and GrubHub, is leading a $10 million round for Freespira, an FDA-cleared digital therapeutic proven to significantly reduce or eliminate panic attacks and PTSD symptoms by training users to normalize respiratory irregularities. - In 28 days, Freespira can reduce or eliminate panic attacks and PTSD symptoms from home with just a tablet, sensor, and custom app. There’s no medicine with possible side effects and no need
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Pear Therapeutics Raises $80M to Advance Prescription Digital Therapeutics

by Jasmine Pennic 12/08/2020 Leave a Comment

Pear Therapeutics Raises $80M to Advance Prescription Digital Therapeutics

What You Should Know: - Pear Therapeutics today announced that it has successfully closed an $80 million Series D financing led by SoftBank Vision Fund 2. -  Pear is the leader in prescription digital therapeutics and the first company to receive FDA authorization for a prescription digital therapeutic (PDT) to treat disease. - Pear currently has three FDA authorized therapies, reSET, reSET-O and Somryst, for substance use disorder, opioid use disorder, and chronic insomnia,
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Everlywell Secures $175M to Expand Position in At-Home Testing Market

by Jasmine Pennic 12/03/2020 Leave a Comment

Everlywell Announces $175 Million Financing to Expand Consumer Lab Testing and Digital Health Offerings

What You Should Know: - Everlywell secures $175M in Series D funding to expand its virtual care offerings, scale its testing and infrastructure, drive clinical research and disease management through testing, and grow its national leadership position in the at-home testing market. - Since launching in 2016, more than one million people have used Everlywell's tests and digital platform to manage their health and wellness. As more people turn toward digital platforms for their health
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Brigham, Biofourmis Co-Develops Tech Solution to Enable Home Hospital Care

by Jasmine Pennic 12/03/2020 Leave a Comment

Brigham, Biofourmis Co-Develops Tech Solution to Enable Home Hospital Care

What You Should Know: - Brigham is working with Biofourmis on a national rollout of their co-developed technology solution, which has been refined and scaled for use by other healthcare systems across the country seeking to establish and execute similar home hospital programs to alleviate COVID-related capacity issues and to receive 1:1 parity on payments from CMS. - The Hospital@HomeTM platform provides a turnkey, end-to-end ecosystem for any health system that wants to quickly launch
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Recent Executive Hires: CVS Health New President, Cleveland Clinic/Amwell Joint Venture Leadership, Others

by Fred Pennic 11/25/2020 Leave a Comment

Recent Executive Hires: CVS Health New President, Cleveland Clinic/Amwell Joint Venture Leadership, Others

CVS Health Corporation names Neela Montgomery Executive Vice President and President of CVS Pharmacy/Retail, effective November 30, 2020. Montgomery will oversee the company's 10,000 pharmacies across the United States. Montgomery, currently a Board Partner at venture capital firm Greycroft, most recently served as chief executive officer of furniture retailer Crate & Barrel and has nearly 20 years of global retail experience. The Cleveland Clinic and Amwell joint venture appoint
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AliveCor Receives FDA Clearance of Next-Gen EKG Algorithms

by Jasmine Pennic 11/23/2020 Leave a Comment

AliveCor Receives FDA Clearance of Next-Gen EKG Algorithms

What You Should Know: - AliveCor announced they received FDA clearance of new algorithms for use with their personal EKG devices, KardiaMobile and KardiaMobile 6L. These additional determinations will be available via a software upgrade for the Kardia devices in 2021. - The additional FDA-cleared algorithms double the number of heart rhythm disturbances that AliveCor’s Kardia devices can detect, broadening the number of patients who are able to use their remote
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White House Coronavrius Task Force Doubles Down on Rapid Testing Strategy

by Liz Essley Whyte, Reporter, Center for Public Integrity 11/16/2020 Leave a Comment

White House, IBM Partner to Fight COVID-19 Using Supercomputers

What You Should Know: - White house coronavirus task force doubles down on rapid testing strategy to fight the coronavirus as some states say they don’t have the supplies to comply with the federal government’s advice. - This article was originally published by the Center for Public Integrity, a nonprofit investigative news organization based in Washington, D.C. The White House coronavirus task force is doubling down on part of its strategy for halting the spread of the virus:
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Gates Foundation Awards Caption Health $4.95M Grant to Develop AI-Guided Lung Ultrasound System

by Fred Pennic 11/12/2020 Leave a Comment

Caption Health AI Awarded FDA Clearance for Point-of-Care Ejection Fraction Evaluation

What You Should Know: - Bill & Melinda Gates Foundation awards Caption Health a $4.5M grant to support the development of an AI-guided lung ultrasound system. - The grant from the Bill & Melinda Gates Foundation will be leveraged to create new AI technology that allows medical professionals without prior ultrasound experience to perform lung ultrasounds, expanding access to quality medical care. Caption Health, a leading medical artificial intelligence (AI) company, today
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Eko Lands $65M to Expand AI-Powered Telehealth Platform for Virtual Pulmonary and Cardiac Exam

by Fred Pennic 11/09/2020 Leave a Comment

Eko Lands $65M to Expand AI-Powered Telehealth Platform for Virtual Pulmonary and Cardiac Exam

What You Should Know: - Cardiopulmonary digital health company Eko raises $65M in Series C funding to close the gap between virtual and in-person heart and lung care. - The latest round of funding will enable Eko to expand in-clinic use of its platform of telehealth and AI algorithms for disease screening and to launch a monitoring program for cardiopulmonary patients at home. Eko, a cardiopulmonary digital health company, today announced $65 million in Series C funding led by
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