MedTech News Briefs | September 18th, 2023

Monday September 11th

Oncology AI platform developed by Dell along with the University of Limerick. The platform will allow for improved outcomes, treatment, and faster diagnosis. Researchers can additionally understand how to better treat patients who have B-cell lymphoma
Sensors the size of baby aspirin to be used to interpret speech for ALS patients. The sensors were developed by Stanford and are implantable sensors that help to guide speech in the brain. The sensor takes signals from the brain and decodes them using state-of-the-art software.
New ultrasound technology launched by Philips. The new technology allows for “super-resolution contrast-enhanced ultrasound”. This allows for improved assessment for lesion blood flow in cancer patients.

Tuesday September 12th

Bausch + Lomb are seeking $1.9 billion in funding ahead of Xiidra deal. The funding will allow for the acquisition of Xiidra and other Novartis assets. The deal will increase the company’s leverage in the intermediate term and is viewed as strategically sound.
Minimally invasive surgery system for hammer toe launched by Forma Medical. The condition is where the second, third, or fourth toe is bent at the middle. The surgery system called Optimal HT is specifically designed for the condition.
UroMems completes enrollment in their first human study for their UroActive system. The system is a smart, automated artificial urinary sphincter. It looks to help people with stress urinary incontinence.

Wednesday September 13th

FDA provides Q&A document to address combination product guidance concerns. A 2011 FDA document about human factors engineering and a 2016 draft guidance on combination product recommendations drew concerns from drug and device industries. The concerns have led to the recently release document.
Accelerator program from NHS England opens applications for 2024. Successful applicants will receivne 3 years of support and will have life-long access to the NHS Innovation Acclerator alumni network and peer community. The intake themes include maternity, mental health, cancer, respiratory disease, hypertension, diabetes, epilepsy, oral health, and carbon reduction.
Freudenberg Medical introduces an innovative coating process for hypotubes. Hypotubes are an important part of cardiac catheters, helping to deploy stents, reopen constricted coronary arteries, and opposing heart attacks. The hypotube requires special coating and precision. With Freudenberg’s new coating process, material and chemical use has been cut in half. The process also improves precision, operator safety, and sustainability.

Thursday September 14th

Harvard Wyss Institute researchers have developed a microneedle patch that can non-invasively sample interstitial fluid from melanoma lesions, enabling the measurement of important biomarkers for treatment response. This innovative approach offers the potential to identify responsive melanoma patients and monitor treatment progress effectively, using highly sensitive biomarker analysis techniques.
The FDA has issued new guidance for medical devices that come into contact with intact skin, whether for a limited or prolonged duration, and are constructed from synthetic polymers or natural fabrics. The guidance outlines requirements for materials used in these devices, clinical trials, regulatory pathways, and labeling, but excludes devices with metal or adhesive components.
Navigation Sciences, a company based in Brookline, Massachusetts, has closed the initial $3 million tranche of a $5 million Series B financing round. They are developing the NaviSci system for precision surgery in early-stage lung cancer, which offers real-time guidance for surgeons during minimally invasive procedures, helping with margin measurement and preserving lung tissue, ultimately aiming to improve surgical oncology outcomes.

Friday September 15th

PathMaker Neurosystems has initiated an early feasibility study to investigate its non-invasive neuromodulation device in patients with amyotrophic lateral sclerosis (ALS). The trial will assess the MyoRegulator device’s ability to suppress motor neuron hyperexcitability via skin pads placed at spinal and peripheral sites, potentially offering a non-pharmaceutical, non-invasive treatment option for ALS patients.
Researchers at the University of California San Francisco have developed a brain-computer interface that allows individuals with severe paralysis to communicate not only through speech but also through facial expressions using a digital avatar. This groundbreaking system decodes brain signals for speech and facial expressions, enabling more complete and natural communication, with decoding speeds of up to 80 words per minute.
Inspira Technologies, based in Ra’anana, Israel, has submitted its Inspira ART100 cardio-pulmonary bypass device for FDA clearance. The system aims to transform external breathing, potentially reducing the reliance on mechanical ventilation machinery and improving patient outcomes.

Sources

ThinkMedTek