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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, BD, Centogene, Cochlear, Inmode.
LONDON – Owkin Inc. added a further $18 million to its series A, bringing the amount raised in the round to $70 million and equipping the company to push forward with its federated learning approach to applying artificial intelligence (AI) to the analysis of health data.
With the push for value-based care, health care players – from manufacturers, to providers, to payers – are looking for ways to improve patient quality while reducing the costs of care. Advanced technologies, including digital health and artificial intelligence (AI)-based tools, are a major part of the equation, but companies face several challenges and barriers to adoption. To that end, management consultancy has launched a new Health Tech website featuring a Health Tech Industry Accounting Guide and other helpful advice for health-tech companies.
TORONTO – Industry-led accelerator Next Generation Manufacturing Canada (NGen) has dipped into its CA$50 million (US$37 million) supercluster fund to help three Canadian companies beef up the nation’s supply of COVID-19 equipment and medical devices.
Evidation Health Inc. reported good news this week in the form of the close of $45 million in series D funding, with an eye toward the expansion of its research platform, Achievement, to include virtual health. B Capital Group led the round, with Mckesson Ventures and Section 32 joining, in addition to existing investors Revelation Partners, Rethink Impact and SV Health Investors.
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