The recent 510(k) clearance by the U.S. FDA for a core part of Precision Neuroscience Corp. brain-computer interface technology is certainly a boon for the company, and others developing the devices. For the millions of people suffering from health disorders, such as motor neuron disease, spinal cord injury or severe stroke, its sign that a solution which could transform their lives could be just a few years away.
Safeheal SAS raised €35 million (US$39.72 million) in an oversubscribed series C financing round for its temporary endoluminal fecal bypass system, Colovac, which is placed in the colon following colorectal resection. The funds will be used to complete an investigational device exemption pivotal study and speed up preparation for commercial launch of the device.
Aktiia SA raised $42 million in an oversubscribed series B funding round and rebranded to Hilo. The funds will be used for product innovation, expansion into new markets and to build out its blood pressure monitoring platform to support enterprise use cases.
Viromed Medical AG recently signed a couple of deals to get its devices based on cold plasma technology into the hands of clinicians to treat patients with skin diseases and pneumological infections.
Deepull Diagnostics SL raised €50 million (US$56.93 million) in an oversubscribed series C financing round to complete clinical validation studies of its UllCORE diagnostic system for direct-from-blood rapid pathogen detection.
Med tech companies were reminded that there are opportunities in emerging and growing markets as they look for ways to adapt to the uncertainties created by the U.S. administration threats of import tariffs. With large populations, and relatively untapped markets, these opportunities represent new destinations for the med tech products. However, the U.S. cannot easily be replaced and there will be challenges in these markets, delegates heard at the LSX World Congress, in London.
Vivasure Medical Ltd. received CE mark approval for its Perqseal Elite vascular closure system which manages bleeding complications associated with large-bore arterial vessel closure. The sutureless, fully bioresorbable device has the potential to reduce problems associated with traditional closure methods in patients undergoing complex structural heart procedures.
The U.S. FDA granted breakthrough device designation to Mursla Bio Ltd.'s Evoliver. The biopsy blood test uses extracellular vesicles to survey hepatocellular carcinoma in high-risk cirrhotic patients.
AMT Medical BV raised $25 million in a series B financing round for its Excimer Laser Assisted Non-Occlusive Anastomosis heart bypass system. The funds will go towards clinical trials and regulatory approval for its sutureless coronary bypass technology designed to replace traditional open-heart bypass surgery.
