Australian digital medication management company Medadvisor Ltd. raised AU$17 million (US$11.4 million) via an oversubscribed placement in which U.S. health care solution provider HMS Holdings Corp. was a cornerstone investor, putting up $11 million and becoming the firm's largest shareholder with a 13% stake in the digital health company.

Houston-based startup Braincheck Inc. scooped up $8 million in series A funding in a round led by S3 Ventures and Tensility Venture Partners, along with True Wealth Ventures and Nueterra Capital. Braincheck launched its digital cognitive assessment tool in 2015 and a cognitive care planning solution in 2018, and now the company is looking to broaden its footprint with physician practices, hospitals and health systems. Proceeds from the financing will help to build the company's sales and marketing and clinical development teams in Houston, as well as production development staff in Austin.

Medicare coverage of digital health is evolving, but there are those who have argued that the U.S. Centers for Medicare and Medicaid Services (CMS) is moving too slowly to capitalize on significant opportunities. The Advanced Medical Technology Association (Advamed) said in comments to the docket for the draft physician fee schedule that an advisory panel should be regularly convened in order to exploit the potential for digital health to "transform the delivery of care and improve patient care outcomes."

The FDA has reissued a 2017 draft guidance for clinical decision support (CDS) applications as part of a reexamination of software regulations, and one difference between the 2017 draft and the latest iteration that is sure to cheer developers is that the agency now provides much more clarity as to the types of functions that will and will not fall under regulatory scrutiny going forward.

LONDON – The first systematic review and meta-analysis of the accuracy of artificial intelligence in health care has concluded AI may be as good as clinicians in interpreting medical images, but it is hard to be sure because of the poor quality of published studies. Researchers at Birmingham University, U.K. considered 31,887 journal papers appearing between January 2012 and June 2019, of which 20,530 were screened. They found most were methodologically flawed.

Corvia Medical Inc. is enrolling patients in a 100-site multinational study of its Interatrial Shunt Device that will measure traditional heart failure endpoints as well as biosensor data transmitted to the cloud for analysis by Napier, Ill.-based Physiq's artificial intelligence analytics. The trial will evaluate Tewksbury, Mass.-based Corvia's device in heart failure with preserved and mid-range ejection fraction.

LONDON – Kaia Health Software GmbH closed an $8 million funding round that it will use to accelerate U.S. commercialization of its digital health apps for managing musculoskeletal disorders and chronic obstructive pulmonary disease (COPD).

Bayer AG led a $40 million series B financing for Informed Data Systems Inc. (IDS) and its One Drop diabetes management platform. The pharma giant also inked a licensing agreement to leverage IDS, which does business as One Drop, in therapeutic areas beyond diabetes and secured a seat on One Drop's board of directors.

WASHINGTON – The 2019 annual forum hosted by the Medical Device Innovation Consortium (MDIC) takes place as the National Evaluation System for health Technology (NEST) approaches full operability. Acquiring the data needed to employ NEST as a source of real-world evidence (RWE) is still an issue. Harlan Krumholz, a cardiologist and health care researcher at Yale University and Yale-New Haven Hospital, said that disruption of the business models of the "data oligopolies" is critical for use of RWE for devices in both the pre- and postmarket settings.

New med-tech investment firm Vensana Capital reported Wednesday that it has closed an inaugural fund, Vensana Capital I, with $225 million in committed capital. The venture capital and growth equity investment firm, launched earlier this year, aims to use the fund to invest in 10 to 12 companies, with commitment sizes ranging from $10 million to $30 million per company.

The fund, which was oversubscribed, will focus on companies across the med-tech sector, including medical devices, diagnostics and information systems, digital health, drug delivery and technology-enabled services. Vensana does not plan to invest in biopharma ventures.