Medtronic plc has launched a single-use device for outpatient-based treatment of chronic, obstructive Eustachian tube dysfunction (ETD). Medtronic’s FDA-approved Nuvent system is a manually controlled balloon catheter for insertion into the Eustachian tube canal. Once pressurized, the balloon expands and dilates the Eustachian tube canal to relieve symptoms of ETD.

Oxford Biodynamics plc is launching its clinical assay Episwitch CIRT in the U.S. following clinical validation that demonstrated the 3D genomic eight biomarker panel can predict a cancer patient’s response to immune checkpoint inhibitor (ICI) therapy at up to 93% sensitivity, 82% specificity and 85% accuracy. ICIs are currently used against more than 15 types of cancer but less than one in three patients show any benefit from the treatment.

Neurosigma Inc. has received FDA breakthrough device designation for its Monarch ETNS system to treat drug-resistant epilepsy (DRE). The neuromodulation therapy uses noninvasive external trigeminal nerve stimulation (ETNS) to treat neurological and neuropsychiatric indications. The technology is currently commercialized for pediatric ADHD treatment.

A neurostimulation device developed to treat focal epilepsy has received breakthrough device designation from the FDA. Precisis AG’s Easee [Epicranial Application of Stimulation Electrodes] minimally invasive system is designed to deliver individualized brain stimulation without neurosurgery. The electrode is placed subcutaneously on the cranium and a current is applied to the affected brain area to prevent or mitigate seizures.

Abbott Laboratories’ Cardiomems heart failure (HF) system is open to a larger patient population following an expanded approval from the FDA. Abbott’s system had previously been approved for class III HF patients that had been hospitalized for HF in the past year. A new expanded indication enables the sensor to be utilized by class II (earlier stage) HF patients and those whose blood test show elevated levels of biomarkers known as natriuretic peptides. The FDA based the approval on findings from the GUIDE-HF trial, which suggested class II HF patients and patients with elevated natriuretic peptides had better outcomes when their therapy was guided by pulmonary pressure monitoring, with a 34% and 25% reduction in heart failure hospitalizations and emergency visits, respectively, based on study data adjusted for the impact of COVID-19.

U.K. startup Tympahealth Technologies Ltd. has received $8 million in seed financing for commercialization of its point-of-care hearing health assessment system. The Tympa system is a CE marked and FDA-registered device for high-resolution ear drum visualization, ear wax removal and hearing screening assessments. Health care entrepreneurs Maurice Ferre and Arjun Desai led the financing round.

Swiss spinal surgery company Neo Medical SA has closed a $20.6 million financing round led by Swisscom Ventures. The funds will be used for U.S. commercialization of the company’s Advise augmented reality (AR) platform for spinal surgery. The platform is due to launch this year and will complement Neo Medical’s existing implant and instrument solutions. “The funds will be used for recruitment of sales direct sales force, training and education activities in the U.S. as well as U.S. scientific and clinical activities,” Neo Medical CEO Vincent Lefauconnier told BioWorld. “In 2022, we will see some key scientific and clinical work being published showing the massive benefit for patient of the use of our unique combination of technologies.”

Collplant Biotechnologies Ltd. has signed a collaboration agreement with 3D bioprinting company Cellink AB for future commercial production of regenerative breast implants. Rehovot, Israel-based Collplant has developed prototypes of 3D bioprinted implants and is evaluating them in preclinical studies. The regenerative implants are designed to degrade over time and be replaced by new, naturally grown breast tissue. The technology aims to overcome the challenges of existing breast procedures that use silicone implants or autologous fat tissue transfer.

The U.S. FDA has granted Datar Cancer Genetics Ltd. a breakthrough device designation for a blood test to detect early-stage prostate cancer. The circulating tumor cell (CTC) detection blood test can identify early-stage prostate cancer in men of age 55-69 years at around 99% accuracy.