Startups & SMEs

Speakers focused on whose role it is in the EU to support manufacturers who struggle to interpret the medtech regulations.

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.

Swiss-based start-up DeepPsy aims to streamline mental health care using EEG and ECG biomarkers to better match depression patients with treatments. Co-founder Mateo de Bardeci discusses the company’s vision as it launches its in-house medical device as a service in Switzerland.

The Innovative Device Access Pathway pilot has launched in the UK with eight new promising medical technologies. The cohort is overwhelmingly diagnostic-focused, with innovative testing for Alzheimer’s, stroke, and liver cancer, amongst others.

Three UK medtech companies’ views on how their businesses will be influenced by external factors in the coming year.

Biobeat defies the usual trend of start-ups seeking ever-growing sums of capital before either going public or being acquired. Its CEO, Arik Ben Ishay, believes the company can quickly become self-sufficient by tackling endemic problems.

“There’s no one company, government, person or technology who is positioned to ‘solve’ the health of the world,” notes Haleon's Nick Tate. Which is why OTC companies are partnering with tech firms large and small to create the next generation of consumer healthcare products and services. In the first part of an exclusive interview on the future of digital consumer health, Tate – who heads up the firm’s incubator business, Haleon NEXT – discusses some of the complications of tech innovation that make such collaboration attractive.    

The EU Innovative Health Initiative has opened its doors to a new round of applicants, with opportunities for the medtech sector to form research groups with other stakeholders and work on projects including novel diagnostics and digital mental health tools.

Marc-Pierre Möll, CEO of German medtech-industry association BVMed, is hoping for a more collaborative year in 2023 after the health ministry came out with proposals to change the DRGs system and the EU finally conceded that its unhelpful MDR timetable was riding roughshod over the wellbeing of patients.

Spectaris’ Marcus Kuhlmann describes Medica as a valued hub to meet member companies and host ecosystem and trade updates for the wider medtech industry. The German industry association’s medtech leader spoke to Medtech Insight during the 2022 event about the top concerns for manufacturers.

The Medtronic Neurovascular Co-Lab Platform is an “always on” online portal that will help Medtronic identify and work with developers of new technologies to prevent and treat strokes, a major cause of death and disability that is rarely treated effectively.

Is regulating artificial intelligence a good idea? A lawyer questions whether the European Commission’s proposed AI Act is appropriate for medtech, where a growing “regulatory lasagna” could compound notified body capacity issues and SME workload.

Sparta Biomedical is developing a synthetic cartilage-on-titanium knee implant based on its proprietary Galene process for infusing cellulose fibers with polyvinyl alcohol. The company hopes to begin clinical trials in 2023.

Congress extended the Small Business Innovation Research and Small Business Technology Transfer programs, right before they were set to expire on 30 September.

The two federal agencies are working together to research rare conditions and fund grants for small businesses creating medical device development tools.

The CEO of a medtech firm that has received multiple innovation grants from the US government says small companies like hers would be endangered if the funding disappears.

Ostomy bags can leak and cause problems for patients and health care workers, so Anne Inch created a device in her attic to solve that problem and has begun to commercialize it.