Lucira Health announced it filed for Chapter 11 bankruptcy last week just as the diagnostics company received Emergency Use Authorization from the FDA for an at-home combination COVID-19 and flu test.
In the company's bankruptcy filing, it lists about $146 million in assets and liabilities of around $85 million. Lucira plans to use approximately $4.5 million cash on hand to fund operations as it...
RapidAI, a health tech company specializing in imaging analysis software, announced it received FDA 510(k) clearance for its Rapid RV/LV product that aims to speed up the pulmonary embolism triage and care process.
Rapid RV/LV analyzes Computerized Tomography Pulmonary Angiograms and calculates the ratio between the right ventricle and left ventricle after a scan. The difference in measurement...
Online birth control pharmacy The Pill Club reached an $18.3 million settlement with California authorities for allegedly defrauding the state's Medicaid program.
According to the California Department of Justice, the company billed Medi-Cal for services it hadn't provided, allegedly submitting claims for 30-minute face-to-face counseling sessions when its nurse practitioners didn't have direct...
Amazon cleared a regulatory hurdle in Oregon as it advances its plans to acquire primary care provider One Medical.
The Oregon Health Authority approved the deal in late December, saying it's unlikely to substantially decrease access to affordable healthcare in the state. One Medical currently operates five clinics in the Portland metro region.
However, the agency did provide conditions for the...
The U.S. International Trade Commission ruled Thursday that Apple Watches with ECG functionality violate two AliveCor patents, but the agency put an import ban on hold.
The ITC issued a limited exclusion order prohibiting further imports and a cease and desist order against Apple. It also set a bond of $2 per unit imported or sold during the Presidential review period. However, enforcement of...
Dexcom announced last week that its G7 continuous glucose monitoring system has received FDA clearance.
The latest model of its CGM, which can be used by people with all types of diabetes ages 2 and up, is expected to launch in the U.S. early next year. As the company works out insurance coverage for the G7, it plans to offer cash payment options for early adopters.
The CGM fits on the back of...
Several federal government agencies have released an updated "trail guide" that aims to help health app developers understand which privacy laws and regulations apply to their technology.
The Mobile Health Apps Tool was produced by the Federal Trade Commission as well as the Office of the National Coordinator for Health Information Technology, the Food and Drug Administration and the Office for...
Ramesh "Sunny" Balwani, former COO and president of the failed blood-testing startup Theranos, was sentenced to nearly 13 years in prison Wednesday.
Balwani was found guilty on all 12 charges he faced this summer, including 10 counts of wire fraud and two counts of conspiracy to commit wire fraud.
Elizabeth Holmes, the former CEO of Theranos, who was also previously romantically involved with...
Avenda Health received FDA 510(k) clearance for AI-backed clinical decision support software that assists physicians in prostate cancer care.
iQuest, which officially received the agency green light late last month, is meant to be used alongside MRI and biopsy results. The system uses specific patient data and deep learning to build a "tailored map" showing where cancer is located in the prostate...
Editor's note: This article has been updated with additional comment from AliveCor.
Apple notched a win against AliveCor, a medical device company that makes personal ECGs, in a long-running battle over wearable heart-monitoring technology.
The U.S. Patent and Trademark Office's Patent Trial and Appeal Board determined on Tuesday that three AliveCor patents regarding the detection of heart...
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