Fierce Medical Devices

The FDA has cleared its first fully disposable duodenoscope, following years of reports of infections being transmitted between patients by the notoriously difficult-to-clean devices, and efforts earlier this year to urge the industry to move toward safer designs.

Caresyntax, a Boston-based startup looking to bring automation and artificial intelligence to the operating room, has garnered $45.6 million in new funding and picked up an OR-focused data firm to broaden its footprint.

A study of Foundation Medicine’s FoundationOne liquid biopsy test found it was able to predict the risk that a person’s breast cancer would return after being treated for early-stage triple-negative disease.

A decade-long study found patients with early breast cancer may be spared radiation procedures that span the whole breast, and that shorter and less invasive courses of treatment aimed at portions of the breast may be just as effective.

The idea of a cell therapy for Parkinson’s disease starts out simple: By replacing lost neurons with new dopamine producers, researchers hope to renew the brain’s connection to the body’s muscles and improve a person’s overall motor function. But in the brain, everything becomes more complicated.

Johnson & Johnson Vision announced that the worldwide president of its surgical business, Tom Frinzi, plans to retire at the end of this year, following a 35-year career in ophthalmology. He has been succeeded by Warren Foust, who most recently served as worldwide president of J&J’s aesthetics and plastic surgery company, Mentor.

Philips looked back on 15 years of data from one of its telehealth-equipped intensive care units and found that centralizing operations and vital sign monitoring helped reduce lengths of stay as well as overall mortality.

As its new CEO begins to move Sanofi away from new diabetes research, the drugmaker—and producer of one of the world’s top-selling insulins—will also look to pull back from its three-year-old relationship with Verily and their virtual diabetes clinic, Onduo.

AstraZeneca is linking up with DeepMatter, a big data firm focused on achieving reproducibility in chemistry, to help improve the productivity of its automated compound synthesis operations.

Boehringer Ingelheim tapped the drug discovery company Healx to help identify new indications for molecules within its pipeline, and to leverage its artificial intelligence platforms to explore their potential against rare neurological conditions.

CMR Surgical plans to bring on a new CEO at the top of the year, as it kicks off the global commercialization of its modular, minimally invasive Versius system following a $240 million funding round.

The Alzheimer's Drug Discovery Foundation announced its second round of diagnostics research awards for the year, with a total of $6 million in new funding for blood tests, eye exams and other tools.

Takeda is teaming up with the Dutch testing firm Enzyre to develop an at-home diagnostic device that will help people with hemophilia to determine their own coagulation status.

Foundation Medicine received a new companion diagnostic approval from the FDA for its FoundationOne CDx test, now for selecting breast cancer patients for treatment with Novartis’ Piqray targeted therapy.

Akoya Biosciences, developers of spatial tissue and biomarker analysis hardware, has raised $50 million to help boost its commercialization and lay more in-roads into research, drug development and clinical testing markets.

The dream of a comfortable, tabletop blood testing device, needing only a few drops taken from a finger and a handful of minutes, has now arrived in the U.S.—and this time carrying an official FDA clearance.

Not long after announcing a wide-ranging partnership with Microsoft to bring artificial intelligence tools to every desk across its R&D departments, Novartis is now teaming up with Amazon’s mammoth cloud computing division to overhaul its manufacturing, supply and business operations.

Biostage’s lab-grown replacement esophagus candidate has been placed on a clinical hold by the FDA as the company works to field questions from the agency before beginning initial human testing.

The first product from Ethicon's collaboration with the plasma-focused Grifols, the Vistaseal spray combines two clotting agents found in the bloodstream to quickly control excessive bleeding during open surgeries or minimally invasive procedures.

A vast cache of FDA records released this summer, covering tens of thousands of device safety reports, have begun taking on a life of their own.