Serac Healthcare Ltd.’s imaging agent, 99m Tc-maraciclatide, enables visualization of early-stage endometriosis, preliminary data from a study presented last week at the Society for Reproductive Investigation conference in Vancouver demonstrated. With millions of women suffering from the debilitating condition globally, maraciclatide has the potential to not only help with diagnosis but also with the development of new therapeutics, David Hail, CEO of Serac, told BioWorld.
Vicore Pharma Holding AB was granted a U.S. FDA breakthrough device designation for Almee, a cognitive behavioral therapy (CBT) software, to be used as an adjunct treatment by patients with anxiety symptoms due to pulmonary fibrosis. Vicore developed the nine-week CBT digital therapy in partnership with Alex Therapeutics AB.
Affluent Medical SA said that its artificial sphincter, Artus, which treats stress urinary incontinence, was successfully implanted into the first patient. The company hopes that the device, which is the first artificial urinary sphincter that can be activated by the patient with a remote control, will be able to improve the quality of life of the millions of people suffering from urinary incontinence.
Thermology Health Ltd. is looking to raise £3 million to £4 million (US$3.8 million to US$5 million) to help bring its thermal imaging technology to patients to better diagnose and prevent diabetic foot ulcers, Yuval Yashiv, CEO told BioWorld. The company’s AI-driven remote patient monitoring platform measures the temperature of the skin on the foot and detects whether an ulcer is forming, thereby preventing thousands of foot amputations and significantly reducing health care costs, said Yashiv.
Sooma Oy recently raised €5 million (US$5.4 million) in funding to help the company expand access to its transcranial direct current stimulation device which allows patients to treat their depression at home. “This is a significant milestone for us that enables us to help more patients globally and help us develop the company to serve the unmet need,” Tuomas Neuvonen, Sooma's co-founder and CEO, told BioWorld.
Pulsecath BV secured a CE mark under the Medical Device Regulation (MDR) for its Ivac 2L system, a percutaneous mechanical circulatory support device, four years after it began the process. “It took us four years and we spent more than €700,000 to get approval under the MDR for the same product that we already had CE mark for under the Medical Device Directive for the last 10 years or so,” Oren Malchin, CEO of Pulsecath, told BioWorld.
Advanced Medical Solutions Group plc (AMS) signed an agreement to buy Peters Surgical SAS for up to €141.4 million (US$154.6 million). The move by AMS for the tissue repair and skin closure manufacturer is part of its strategy to buy assets which will strengthen its product portfolio and broaden its global reach.
Epitomee Medical Ltd submitted its application to the U.S. FDA for 510k regulatory clearance for its swallowable weight loss capsule. It joins a host of companies offering solutions to the global obesity crisis.
The U.K. government said it will take action to tackle potential bias in the design and use of medical devices after an independent review found that there is extensive evidence of poorer performance of certain technologies, like pulse oximeters, in patients with darker skin tones.
Rehab Technologies Lab recently unveiled a new robotic exoskeleton, Twin, designed for lower limbs to allow patients with spinal cord injuries to walk independently. Although Twin is currently a prototype, the company will work towards getting CE mark to bring it to the market to help patients with physical impairments integrate back into social and work environments.
