Quanterix Corp. plans to merge with Akoya Biosciences Inc., in an all-stock transaction that both companies hope will bolster their fortunes. The transaction will create an integrated solution for ultra-sensitive detection of blood- and tissue-based protein biomarkers.

The U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program has its benefits, but industry had some sharp words for the agency in commenting on the 2024 ASCA draft guidance. The Advanced Medical Technology Association stated that FDA reviewers asked for full conformity test results for roughly 5% of premarket applications, a rate seen as excessive given the program’s design.

The U.S. FDA posted a draft guidance that would revisit a 2014 final guidance on sex-specific data drawn from medical device clinical trials, expanding the scope to include considerations of gender.

Medtronic plc secured CE mark approval under the EU Medical Device Regulation for its Brainsense adaptive deep brain stimulation system. The technology represents a major advancement in the treatment of Parkinson’s disease as it provides real-time, self-adjusting brain stimulation based on the patient’s brain activity, offering a more personalized therapy.

In the first patenting to emerge from Carlsbad, Calif.-based Biologic Input Output Systems Inc., its chief development officer, Timothy Miller, collaborated with academics on the development of implantable neural interfaces for placement in the peripheral nervous system.