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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

April 23, 2024

View Archived Issues
Artistic rendering of deep brain stimulation.

Neurovalens gets FDA nod for neurostimulator to treat anxiety

Neurovalens Ltd recently received U.S. FDA clearance for its Modius Stress device, a neurostimulator that treats people suffering from generalized anxiety disorder (GAD). It also closed a £2.1 million (US$2.65 million) funding round and is planning to raise up to $50 million in a series B fundraising round to be launched later this year. Read More
3D map of China

China’s NMPA may expect domestic HFE work for imported devices

China’s National Medical Products Administration (NMPA) has issued a guidance for human factors engineering (HFE) of medical devices, a document that by some accounts aligns fairly well with guidance from the U.S. FDA. However, Yvonne Limpens, manager of the human factors program at Emergo by UL, said NMPA may push for domestic HFE testing on imported devices because of a perception that device usability may be different in China than in other nations, thus adding to the cost of doing business in the world’s second most populous nation. Read More
Illustration of cancer tumor on pancreas

Molecular You reports ‘breakthrough’ in early detection of pancreatic cancer

Molecular You Corp. said it has achieved a significant milestone in the early detection of pancreatic cancer. A case report, published in the journal OMICS, described the effectiveness of the company’s proteomic and metabolomic analysis – known as longitudinal multiomics monitoring (LMOM) – in identifying pancreatic cancer in a symptom-free 60-year-old female patient. A biopsy on lesions discovered because of the company’s diagnostic tests confirmed stage 1 pancreatic cancer. Read More
China in red on globe

Royal Philips hit with FDA warning over facility in China

Royal Philips NV may feel it has had enough recent interaction with the U.S. FDA, but the company is now in receipt of a warning letter from the agency over a facility located in Suzhou, China. The FDA was none too fond of the facility’s handling of a contract manufactured data cable used in CT systems because of malfunctions that may have delayed diagnostic imaging procedures, representing yet another regulatory distraction for a company that recently cleared a long-running conflict with the FDA over CPAP machines. Read More
CAR T cell with map of China as nucleus

CAR T pipelines bloom to treat world’s largest cancer population

As of Jan. 31, 2024, there were more than 300 CAR T trials registered in China, surpassing the U.S. and becoming the country with the most CAR T therapy clinical trials. Among them, CD19 is the most frequently studied target, according to BioWorld and Cortellis. The rapid evolution of CAR T-cell therapies in China has escalated over the past decade from the start of the first clinical trials in 2013 to the country becoming an established host for CAR T-cell-related trials by 2017, according to Yongxian Hu and researchers from Zhejiang University in Hangzhou, China. Chinese cell therapy companies – backed by $2.37 billion in funding in 2021 – have since significantly increased basic research and trial output for CAR Ts, which was welcomed by large patient demand. Read More
tumor treatment pfa

Former Farapulse researcher applies PFA know-how to tumor treatment

In what represents just the company’s fourth PCT filing, San Jose, Calif.-based Squirrel Corp. seeks protection for systems for electroporation or pulsed field ablation (PFA) treatment of soft tissue tumors. Read More

Appointments and advancements for April 23, 2024

New hires and promotions in the med-tech industry, including: Cel-Sci. Read More

Financings for April 23, 2024

Med-tech firms raising money in public or private financings, including: Genetic Technologies, Glucotrack. Read More

In the clinic for April 23, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bluewind. Read More

Other news to note for April 23, 2024

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Neuronoff, Thermedical. Read More

Regulatory actions for April 23, 2024

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Epitel. Read More

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