In a sweet indication of an improving capital market for med-tech companies, Biolinq Inc. landed $58 million in venture financing to support completion of the U.S. pivotal trial of its intradermal glucose sensor and submission to the U.S. FDA. The wearable patch features an array of tiny electrochemical sensors designed to measure multiple analytes in the intradermal space, meaning it does not require an introducer needle that penetrates to subcutaneous tissue.

US FDA struggling to keep up with clinical research inspections

The lingering effects of the COVID-19 pandemic and ongoing recruitment/retention issues are making it difficult for the U.S. FDA’s bioresearch monitoring (BIMO) program to keep up with the on-site clinical research inspections that are a cornerstone of the preapproval process for new drugs, biological products and medical devices. The resulting delays could threaten the approval timelines for many products. According to a recent report from the Government Accountability Office, about 6% of all clinical research inspections assigned to BIMO investigators from fiscal 2018 through July 2023 were unable to be completed. In that same timeframe, the Center for Drug Evaluation and Research reported that about 30% of its BIMO clinical investigator inspections, which account for the majority of the FDA’s clinical research inspections, needed extensions beyond the requested due date.

Australia’s anti-trust watchdog clears Cohlear-Oticon revised deal

Australia’s Competition and Consumer Commission (ACCC) said it will not oppose Cochlear Ltd.’s proposed acquisition of the cochlear implants business of Denmark’s Oticon A/S after the bone conduction businesses was removed from the deal. When Sydney-headquartered Cochlear announced its intent in April 2022 to acquire Oticon’s bone conduction business and cochlear implants business in a deal valued at $121 million, the ACCC opposed the deal because it had competition concerns related to the bone conductions solutions business.

Carelight describes wearable smart sensors for physiological monitoring

Carelight Ltd. reported seeking protection for a wearable real time opto-physiological monitoring system (OPM) for monitoring heart rate, respiration rate, oxygen saturation, blood pressure, heart rate variability, pulse wave velocity, and body temperature. The inventors noted how current photoplethysmography-based pulse oximetry devices are often inaccurate as they do not take into account the dynamic changes of tissue optical properties in biological live tissue, motion induced artefacts or the effects of sweat, skin creams or sprays. Carelight’s OPM system may be designed as wearable, e.g., a patch, watch or ring, and uses a multispectral optical sensor, capable of receiving a range of wavelengths of electromagnetic radiation, to obtain an indication of at least one physiological property.

Beckman Coulter hit with recent US FDA warning

The U.S. FDA posted a device warning letter in the first week of April 2024 to Beckman Coulter Inc., of Brea, Calif., at the Chaska, Minn., facility that manufactures the DxI 9000 analyzer, which the company introduced to the market last year. The warning letter said that the Chaska facility’s corrective and preventive action procedures failed to ensure that an observed problem with printed circuit boards used in the DxI 9000 would not recur, a problem the company said will be resolved shortly.

Aging, and aging well, gives clues for dementia drug discovery

Ironically, the first person to be diagnosed with what is now Alzheimer’s disease (AD) was missing its major risk factor. When she first began showing symptoms of dementia in 1901, Auguste Deter was not particularly old. Deter became symptomatic at the age of 50 and died in 1906 at the age of 55. Her autopsy revealed the amyloid plaques that would become AD’s anatomical calling card, and the target of a drug discovery effort that would consume decades and untold billions of dollars before delivering its first, moderate, success in 2021. Despite Deter’s case, aging is the largest risk factor for developing Alzheimer’s, by a large margin. But “geroscience has not been translated into drugs for Alzheimer’s disease,” Howard Fillit, Alzheimer’s Drug Discovery Foundation co-founder and chief scientific officer, told BioWorld. “We’re just starting to see that cross-fertilization now.”

Also in the news

Acclarent, Affinity Biosensors, Alamar Biosciences, Angiodynamics, Biognosys, Biolinq, Brainlab, Cardio Diagnostics, Carl Zeiss Meditec, Click Therapeutics, Co-Diagnostics, Dutch Ophthalmic Research Center, Enable Biosciences, Enable Biosciences, Exact Sciences, Fujifilm, Haemonetics, Icon, Integra Lifesciences, Kryptos, Medcura, Monteris Medical, Navierre, Nucleix, Otsuka, Regenative Labs, Spineology, Stevanato Group