Lantheus Holdings Inc. has snagged FDA approval for Pylarify (piflufolastat F 18), a PET imaging agent for the identification of suspected metastasis or recurrence of prostate cancer. The company said the product will be available immediately in the mid-Atlantic and southern regions, with availability across the U.S. by the end of 2021. Read More
Aktiia SA’s cuff-less blood pressure monitor – a connected optical system for continuous monitoring – has launched in Austria, France, Germany, Ireland, U.K. and Switzerland. Aktiia’s monitor is a bracelet that includes a photoplethysmography sensor with a silicon diode receptor capable of measuring the pulse to within an accuracy of ±5 beats per minute, a communication module and a rechargeable lithium-ion battery. Read More
PERTH, Australia – With half the world’s population, Asia Pacific is quickly replacing Europe as the world’s second-largest medical device market, and China, Korea and Australia stand out as leaders, said Tim Schmid, company group chairman for Johnson & Johnson Medical Devices, Asia Pacific, during the recent Ausmedtech 2021 virtual conference. Read More
Startup Aplife Biotech is tapping into the rapidly growing market for biosensors that can expand the capacity of hand-held devices to screen for thousands of pathologies from a single drop of blood. Using technology developed in Argentina to print DNA structures on microchips, the company’s goal is to screen as many as 20 million probes with the potential to convert molecular interactions into electrical signals, opening a path for med-tech developers and manufacturers to explore new solutions for personalized health care. Read More
LONDON – New guidelines for stem cell research open the door to extending the legal limit on human embryo research beyond the current 14-day maximum set down 40 years ago. Read More
Med-tech firms raising money in public or private financings, including: Genapsys, GPB Scientific, Scientia Vascular, Singular Genomic Systems. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: AIM Immunotech, Cardiacsense, Clinical Enterprise, Enspectra Health, Ibex, Implicity, Indica Labs, Metagenomi, Microport CRM, Onduo, Perkinelmer, Smoore. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acutus Medical, Advanced Human Imaging, Avicenna.AI, Lantheus, Micro Interventional Devices, Nowdiagnostics. Read More
