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.
Elucid Bioimaging Inc. has already gained an FDA clearance and a CE mark for its Vascucap artificial intelligence-based software that analyzes CT angiograms (CTA) to characterize and quantify atherosclerotic plaque to predict a patient’s stroke risk. But recent interim data presented on July 2, 2020, at the Society for Vascular Surgery conference found that the AI algorithm is more effective than standard-of-care diagnostics.
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.