Financing
The 12 initial awards, which total almost $100m, are part of an ongoing program to develop a high-tech mobile hospital that can reach patients with limited access to health care.
France-based Germitec aims to double its yearly revenue by expanding its UV-C disinfection technology for endocavitary ultrasound probes into the US market.
Stock prices for liquid biopsy firm Angle Plc are up since 28 January after the release of new research. The study used Angle’s technology to detect clinically relevant mutations in circulating tumor cells that were not found in traditional circulating DNA, allowing for further insights into cancer progression, Andrew Newland, Angle CEO, told Medtech Insight.
Seven new Centers of Excellence for Regulatory Science and Innovation have been funded by the UK with a brief to investigate smart regulation of AI and digital health innovations, among other areas. Medtech Insight asked Alastair Denniston, leader of the CERSI in AI and Digital Health Technologies, to explain the significance and the goals of his center.
Quibim announces $50m in an oversubscribed series A funding round. Quibim CEO Ángel Alberich-Bayarri discusses his plans for the new financing and the company’s competitive edge in training AI with multimodal data.
Dexcom invests $75m in ŌURA, cementing a data-sharing partnership with the smart ring developer.
Exact Sciences lowered its full-year 2024 midpoint guidance by $90m. Commercial adjustments to the sales force are being made "to fix the basics," senior company executives told the Jefferies London Healthcare Conference.
Guardant Health expects to break even by 2028. A positive pricing outlook for the Guardant 360 lab test could bring this forward by maybe one year, CFO Mike Bell told the Jefferies London Healthcare Conference.
Venture capital investment in healthtech is showing signs of early recovery in the first half of 2024 after the long hangover of a downturn that followed booming investments during the pandemic years, according to a new report from Silicon Valley Bank (SVB). Despite ongoing challenges, healthtech is on a positive trajectory and hovers between $3.5bn and $4.5bn per quarter, surpassing pre-pandemic levels.
Marabio Systems says the new funding will help accelerate efforts to bring a blood test to market in 2025 that will accurately determine if a mother is a carrier of antibodies that cause MARA, a subtype of autism that believe to cause more severe behavior.
This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
An additional $50m brings the neurovascular intervention specialist’s total Series F funding to $82m. Route 92 says it will use the capital to build its sales and support teams and pursue regulatory authorizations around the globe for its FreeClimb portfolio while advancing its SUMMIT MAX clinical trial for the investigational Monopoint Reperfusion System.
This week, the FDA announced a new head of its device evaluation office; synthetic genomics firm Constructive Bio landed $58m in funding; and Natera got a permanent injuction against NeoGenomics Labs' RaDaR assay.
This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.
Venture investment in medtech seems to be improving, particularly in diagnostics and tools, and down-value rounds have decreased. However, interest rates are still much higher than three years ago, and many tech investors continue to avoid the health care sector as a whole.
An interactive look at medtech and diagnostics deals made during August 2024. Data courtesy of Biomedtracker.
An interactive look at medtech and diagnostics deals made during July 2024. Data courtesy of Biomedtracker.
Amferia is developing an antimicrobial peptide hydrogel dressing to combat infections in acute wounds in humans and veterinary contexts. Supported by €1.2m of new venture capital financing, the company is planning pivotal clinical studies to support an FDA application later this year and CE mark submission in 2026-2027.
MamaLift Plus, 510(k)-cleared by the FDA in April as the first prescription digital therapeutic for treating postpartum depression, will soon be available for download on the App Store or Google Play. Announced 28 August, Curio has raised $10m in Series A funding to bolster commercial activities.
During a tour of Truvian’s San Diego headquarters, Medtech Insight spoke with the company’s top executives about their unique three-in-one blood-testing benchtop system, plans for FDA regulatory filing, and marketing strategy.