Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Infervision.
Biointellisense Inc. received an FDA clearance in January for its Biosticker to monitor patient vital signs at home for as long as 30 days. It was just starting to launch, when along came the novel coronavirus. Now, the Band-Aid-sized monitor is being used to monitor COVID-19 patients at home, as well as chronic disease patients.
HONG KONG – Hong Kong’s emerging med-tech sector is getting a boost from a government-funded program aimed at sharing technology with other jurisdictions, a program driven in part by the need to contain the COVID-19 pandemic and continue opening regional economies.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baxter International, Diazyme, Infervision, Therapixel.
Virtual care provider Doctor On Demand has scooped up $75 million in a series D round led by General Atlantic, with participation from existing investors. The funds are earmarked to fuel the company’s growth and expand access to comprehensive telehealth services across the U.S. Combined with earlier financings, the San Francisco-based company has raised nearly $240 million to date.
RapidAI, which focuses on imaging for stroke, has received the U.S. FDA’s nod for Rapid ASPECTS. According to the company, it is the first neuroimaging analysis device to gain clearance in the computer-assisted diagnostic software category.
Machine learning-based diagnostics startup Dascena Inc. has won the U.S. FDA’s breakthrough device designation for its Previse algorithm, which is designed to predict acute kidney injury (AKI) before clinical symptoms. In early validation tests, Previse detected AKI more than a day before patients exhibited kidney damage or impaired function.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Asuragen, Dascena, Getinge, Ivwatch, Medtronic, Novartis, RapidAI, Soterix Medical, Viveve.
The comment period has closed on the U.S. FDA’s discussion draft for artificial intelligence (AI) in medical devices, a paper that attracted the attention of medical societies and regulated industry. One of the questions posed by industry was whether the FDA is in a position to deal with the massive volumes of data developers would have to disclose to the agency, creating concern that such disclosures would amount to little more than an obligatory and useless data dump.
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