Roche's Elecsys Amyloid Plasma Panel granted FDA breakthrough device designation to enable a timely diagnosis of Alzheimer’s disease

The Elecsys Amyloid Plasma Panel has the potential to ensure better identification of patients that require further confirmatory testing, supporting a more timely and accessible diagnosis.

USFDA grants Breakthrough Device designation to Nocria’s Migraine treatment

Nocria’s hand-held device uses gentle, controlled puffs of air in the ears for treating migraine attacks

FDA grants breakthrough device designation to Impella ECP, the world’s smallest heart pump

It measures 9 French (3 millimetres) in diameter upon insertion and removal from the body. While in the heart, it expands to support the heart’s pumping function, providing flow greater than 3.5 L/min

FDA grants breakthrough status to Laguna's mRNA blood test for schizophrenia diagnosis

The move puts a spotlight on one of psychiatry’s most persistent clinical challenges: misdiagnosis and delay

Laguna Diagnostics secures FDA breakthrough tag for mRNA test in psychiatric diagnosis

The company receives approval for blood-based test enabling objective differentiation of schizophrenia and bipolar disorder

Mosaic Clinical Technologies’ AI breakthrough earns FDA “Breakthrough Device” designation

Cognita CXR leverages a proprietary vision-language model to analyze full chest X-ray studies and generate comprehensive preliminary findings

Alphatec and Theradaptive forge landmark spine partnership as Series B round launches

ATEC secures exclusive U.S. commercial rights to Theradaptive’s OsteoAdapt osteoinductive bone graft, currently in clinical trials for spinal and dental applications

Transmural Systems wins breakthrough FDA nod for coronary-saving TAVR device

The clearance for TELLTALE positions Transmural Systems at the forefront of next-generation electrosurgical solutions for structural heart interventions

Investors pile in as Cordance secures oversubscribed seed round for brain-cancer tech

The fresh capital will propel Cordance into its first-in-human clinical trial

FDA grants breakthrough status to Augurex’s SPINEstat test to advance early axSpA diagnosis