Fierce Medical Devices

New research from Eisai showed measurable correlations between amyloid biomarkers in the bloodstream and changes in the cerebrospinal fluid, bringing the company a step closer to developing a quick and simple blood test for Alzheimer’s disease.

Elon Musk pulled back the curtain on his brain interface-developing Neuralink in a technology showcase aimed more at recruiting new employees to the secretive company than attesting to its science.

Could wearable biosensors change the face of clinical trials and shorten a drug’s regulatory journey? That’s what Yale University and the Mayo Clinic are trying to find out, using biosensors and Biofourmis’ mobile health platform.

GNS Healthcare has raised $23 million from the venture capital arms of drugmakers and health insurance companies to build out its artificial-intelligence-driven precision medicine platform.

Life sciences incubator Paragon Biosciences has built a new portfolio company around its acquisition of the first FDA-cleared artificial intelligence system for diagnosing breast cancer.

Notable Labs is adding $40 million to its reserves as it scales up its artificial-intelligence-based drug discovery technology with plans to take its platform worldwide.

The FDA approved Bayer’s Gadavist MRI contrast agent to help gauge the blood supply of the heart muscle.

Machine learning-powered drug discoverer Recursion Pharmaceuticals has secured $121 million in new financing for its artificial intelligence programs.

GE Healthcare has recalled two of its infant warmers—bedlike hospital devices designed to radiate heat and track the health of newborns—due to side panels and latches that may crack, break or open, allowing infants to fall.

Abbott has received FDA approval for a new addition to its Alinity line of laboratory diagnostic hardware designed to screen blood and plasma donations for potential contaminants.

Hot on the heels of its international distribution deal with Terumo, Orchestra BioMed has secured $34 million in new funding for its devices aimed at high blood pressure and blocked arteries.

A fresh round of layoffs at the struggling and scrutinized uBiome has left the at-home sequencing test provider without a lab director and other key staff—and with them, its ability to provide an at-home sequencing test.

The Trump administration has put forward an executive order designed to incentivize at-home kidney dialysis, potentially affecting tens of thousands of people who undergo the procedure at commercial clinics.

23andMe’s chief scientific officer and former therapeutics foreman Richard Scheller has left the sequencing company and landed on the boards of at least two biotechs—namely, two of the biggest money raisers of the year so far.

FierceMedTech Fierce 15 winner AblaCare, developer of a device-based approach to treating infertility associated with polycystic ovarian syndrome, has secured €10 million ($11.2 million) in its first major venture capital haul.

Eisai opened its first startup incubator as part of its new Cambridge, Massachusetts-based center focused on exploring the genetic links to dementia and potential immunotherapies.

Dialysis giant Fresenius Medical Care announced plans to expand its work in international clinical research, elevating its North America-centric Frenova research subsidiary to the global stage.

Researchers at the University of Huddersfield in England hope to collect and screen the thousands of organic compounds exhaled with each breath for signs linked to multiple sclerosis.

The diabetes diagnostic-focused AgaMatrix has secured a capital raise of about $56 million, with plans to support clinical trials of a continuous glucose monitoring system being developed under its WaveForm Technologies subsidiary.

In the first patient to receive its pancreatic cell implant for type 1 diabetes, Sernova’s insulin-secreting Cell Pouch showed no adverse events related to the therapy, and was able to help maintain blood sugar levels over at least two weeks.