Inovedis GmbH received clearance from the U.S. FDA for its Sinefix implant system, which can be used to repair rotator cuff tears. Sinefix allows surgeons to refix the rotator cuff tendon to the bone using a simplified surgical technique that aims to significantly reduce the time and cost of the procedure.
Sonio SAS closed its series A fundraising round raising $14 million that will go some way in helping the company deliver on its mission to improve access to quality pregnancy monitoring for women everywhere through its software-as-a-service (SaaS) platform. Sonio has developed an artificial intelligence (AI) prenatal screening solution that automates ultrasound reporting while providing image quality control and detection of potential anomalies. The capital raise was led by Cross-Border Impact Ventures, a North American impact fund dedicated to the health of women and children.
The European Commission (EC) fined Illumina Inc. a record €432 million (US$476 million) for closing the acquisition of Grail Inc. before receiving regulatory approval. It is the highest fine ever imposed on a company by the EC for completing a deal without its consent. Grail was fined €1,000. The companies were found to be in breach of EU merger control rules.
Coloplast A/S agreed to acquire wound care company Kerecis Ehf for up to $1.3 billion in a bid to strengthen its presence in the high-growth, U.S.-centric biologics segment. Kerecis has developed a technology which uses intact fish skin from Atlantic cod to treat chronic wounds. It has around 5% share of the U.S. biologics market.
Parasym Ltd.’s neuromodulation technology significantly decreased postural tachycardia syndrome (POTS) and has the potential to be a safe and effective treatment for individuals living with the condition, according to a recent study. The result from the trial represents a substantial breakthrough for people with POTS, as there are no U.S. FDA approved treatments for the condition, Nathan Dundovic, co-founder at Parasym, told BioWorld.
Electromedical Products International Inc. (EPI) Alpha-Stim AID technology is finally being made available by the NHS in the U.K. to treat patients with anxiety some two years after the National Institute for Health and Care Excellence (NICE) said there was not enough good-quality evidence to support the case for routine adoption.
The €5.5 million (US$6 million) Escala Medical Ltd. recently received from the European Innovation Council will help the company expand its operations as it looks to officially launch its Apyx device in the U.S. later this year, CEO and founder Edit Goldberg told BioWorld. Already FDA-cleared, Apyx offers incision-free pelvic organ prolapse (POP) treatment to the women suffering from the often painful and debilitating condition.
The mortality rate of patients with kidney failure can be significantly reduced if they are treated with high-dose hemodiafiltration compared with the more commonly used high-flux hemodialysis, according to a study recently published in the New England Journal of Medicine. The results from the CONVINCE trial pave the way for the increased adoption of hemodiafiltration as a therapeutic option to treat patients with end-stage kidney disease.
A group of international partners with expertise in therapeutics, technology, health data management and data science have joined forces to develop a range of digital tools that will predict and monitor dementia. The two-year pilot project launched in the U.K. will see the unique group focus their initial efforts on developing data and digital solutions to complement existing treatments as well as solving issues related to the prediction, prevention, management and treatment of dementia related disorders.
The European Society of Hypertension (ESH) has recommended that renal denervation (RDN) be offered as an adjunctive therapy to patients with resistant hypertension. Releasing new and updated guidelines on the management of arterial hypertension, the ESH said recent randomized controlled trials showed that endovascular RDN can be associated with a significant, albeit not marked, office and ambulatory blood pressure reduction in patients with uncontrolled hypertension.
