Business

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.

At this year’s LSX Nordic conference, experts from Baxter, Philips and Novo Nordisk described key attributes they look for when selecting companies for partnerships or acquisitions and provided advice to founders on how and when to start positioning their start-ups for such opportunities.

This week, J&J announced that it was buying heart failure device firm V-Wave; Procept got the FDA’s OK on a clinical trial of its Aquablation treatment for prostate cancer; and CMS began to consider Medicare reimbursement of Abbott’s TriClip tricuspid repair device.

Biopharmaceutical giant AstraZeneca has partnered with start-up “unicorn” Owkin to develop an AI-powered tool to prescreen for gBRCA mutations on the basis of morphological features in digitized pathology slides. Built on extensive, high-quality data sourced from the France-based PortrAIt consortium, the AI will help to prioritize patients for further testing, streamlining the diagnostic process, Owkin says.

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.

Slow adoption of alternatives to animal testing in the current decentralized regulatory framework shows the need for a ‘one-stop shop’ at FDA that can provide advice, precedents and qualification programs.

This week, J&J announced that it was buying heart failure device firm V-Wave; Procept got the FDA’s OK on a clinical trial of its Aquablation treatment for prostate cancer; and CMS began to consider Medicare reimbursement of Abbott’s TriClip tricuspid repair device.

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.

The Octane Medical Innovation Forum brought together industry experts, entrepreneurs and investors to discuss a range of topics. Medtech Insight was on the ground to bring some memorable perspectives from industry leaders.

At this year’s LSX Nordic conference, experts from Baxter, Philips and Novo Nordisk described key attributes they look for when selecting companies for partnerships or acquisitions and provided advice to founders on how and when to start positioning their start-ups for such opportunities.

Industry experts believe the future of medtech will be centered around patients and their data. To thrive, medtech companies must integrate themselves more organically in the patient continuum and adopt more of a Big Tech mindset in order to meet users' evolving expectations.

The Octane Medical Innovation Forum brought together industry experts, entrepreneurs and investors to discuss a range of topics. Medtech Insight was on the ground to bring some memorable perspectives from industry leaders.

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.  

Haleon will launch Futura Medical's FDA-approved OTC medical device for erectile dysfunction in the US before the end of the year. Already available to pre-order online on Amazon, Eroxon represents the firm's first move into the sexual health category. 

Clue Plus members will have access to 50% off a Headspace subscription for tailored guidance, support and validation to help manage cycle-related stress and improve overall well-being.

TRiCares SAS announced it raised $50m in series D funding from a single unnamed investor. The funding will support the company’s upcoming US early feasibility study and EU CE mark clinical investigation for its transfemoral tricuspid heart valve replacement system, Topaz.

UK medical devices manufacturer Owen Mumford moves into consumer health with umbrella brand Clariti and OTC relaunch of at-home vaginismus and dyspareunia treatment Amielle Comfort.

Sofinnova Partners has played an important role in defining the medtech investment space for the past 50 years, helping bring to market a plethora of life-saving technologies, even when they appear, initially, to be risky.

Each year, Medtech Innovator whittles down a vast number of applicants to a relatively succinct shortlist of companies. Paul Grand, Medtech Innovator’s CEO, spoke to Medtech Insight about this process, as well as some of the broader trends impacting investment in medtech.

When a large medtech company sets up a venture fund, it typically invests in technologies that are adjacent to its pre-existing portfolio. Intuitive Surgical’s approach is different.

Keeping a firm grip on one’s IP is a cornerstone of most innovative businesses. However, Robert Cote, CEO of Cote Capital, believes that if the idea is good enough to keep close, it’s good enough to license out.