Masimo's RPVi device has been granted CE mark approval by European regulators. The noninvasive continuous measurement device is the multiwavelength version of the company's Pleth Variability Index and is designed to monitor perfusion index changes during respiratory cycles.
A round of equity and options financing involving 22 unnamed investors pulled in $1.6 million for BioSig Technologies, an SEC filing showed. The company did not disclose how it intends to use the proceeds and is still seeking to obtain $5.4 million in the round.
A round of seed financing brought in more than $1.5 million for Annapolis, Md.-based Vixiar Medical, which makes noninvasive devices for cardiopulmonary disease monitoring. The money will be used to finish regulatory submissions and support of final engineering and initial production for Indicor, the company's point-of-care device and digital platform designed to monitor worsening heart failure.
A round of Series A financing pulled in $8 million for Hinge Health, a startup that offers a kit of hardware and software and a 12-week program to address musculoskeletal disorders. The money will be used to build out the company's sales and product and engineering teams in San Francisco and London, as well as for the expansion of its product offering for lower-back and knee pain to include treatments for shoulder, hip and neck pain.
The worldwide heart valve repair and replacement devices market is expected to see a 10.9% compound annual growth rate through 2021, hitting $8.1 billion, according to a Meddevicetracker report. Edwards Lifesciences dominated the market last year with a 65.7% share, with other players including Medtronic, Boston Scientific, St. Jude Medical, JenaValve Technology, Symetis and Braile Biomedica.
A Research and Markets report predicts the worldwide market for bone growth stimulators will reach $3.9 billion by 2025 with an 8.5% compound annual growth rate because of the increasing number of bone-related issues, the growing patient demand for noninvasive procedures and the expanding number of investment opportunities. DePuy Synthes, DJO Finance, Bioventus, Arthrex, Medtronic, Stryker and Zimmer Biomet are among the key market players.
Updated American Society of Clinical Oncology guidelines indicate that Agendia's MammaPrint 70-gene lab test can guide decision-making for treating women with estrogen receptor-positive or progesterone receptor-positive, HER2-negative breast cancer with lymph node-negative, or up to three positive lymph nodes, who face a high clinical recurrence risk. The recommendation was backed by a 6,693-patient trial that showed the assay could identify patients with high clinical risk but low genomic risk who had a favorable outcome when treated with endocrine therapy alone, leading to a five-year distant metastasis-free survival rate comparable to chemotherapy.
The FDA should scrap the "totality of the evidence" standard in the final tobacco product classification rule's definition of "intended uses" and use the approach provided in its proposed rule instead, AdvaMed wrote in a letter released by the agency last week. Because the standard "is more outcome determinative than prescriptive, manufacturers seeking to avoid potential enforcement action will have no choice but to curb important product-related communications," AdvaMed wrote.
UnitedHealth Group is collecting proposals from agencies looking to take over media planning and buying across the company's brand portfolio, sources say. UnitedHealth Group spent $242 million on measured media in the US last year and $44 million in the first quarter this year, according to Kantar Media.
Small health care companies can get the most out of their marketing budgets by embracing digital tools such as mobile apps and social media channels, writes Eduardo Fernandez, an executive at Exeltis. "Smaller companies are typically more flexible and should take advantage of their ability to explore more innovative marketing actions," he writes.