Shots:
Novanta has entered into a definitive agreement to acquire Riverpoint Medical from Arlington Capital Partners, expanding Novanta’s presence in the minimally invasive surgery market
As per the deal, Novanta will acquire Riverpoint for $1.2B upfront, with $250M in milestone payments expected in Q1’27, representing the total deal value of $1.45B; closing is anticipated in…
Shots:
The FDA has granted IDE approval to initiate a multi-center pivotal study evaluating the Separo Vessel Sealing System vs standard mucosal cautery vasectomy
The trial will enroll 120 adult male subjects across ~5 US centers, with the primary endpoint measuring azoospermia or rare non-motile sperm (≤100,000/mL) within 6mos. following the procedure
The Separo System…
Shots:
The US FDA has approved ECoG Assistant, an AI-powered clinician tool designed to support epilepsy management using data from the RNS System, with NeuroPace debuting the tool at ASSFN’26
ECoG Assistant was developed using 124,450 epileptologist-labeled intracranial EEG records & identifies ECoGs of Interest, enabling clinicians to review long-term EEG trends & circadian activity…
Shots:
The FDA has granted De Novo classification to Cardiosense's PCWP Analysis Software to noninvasively estimate pulmonary capillary wedge pressure (PCWP) in adults with heart failure with reduced ejection fraction (HFrEF), incl. those with LVEF ≤40% & NYHA Class II, III & IV symptoms
The Software integrates its CardioTag wearable sensor with AI to…
Shots:
Myriad Genetics to launch the Prolaris + AI Test, with the new AI metric available for all Prolaris Biopsy Tests in the US from May 29, 2026 excl. New York; approval in NY is expected soon
A validation study of 998 pts for model training & 296 pts for validation, demonstrated that AI-GUR independently…
Shots:
The US FDA has granted BDD to the TOBY Test for diagnosing Alzheimer’s disease in adults (≥50yrs.) with signs and symptoms of cognitive impairment undergoing evaluation for Alzheimer’s disease
The TOBY Test is a non-invasive urine-based diagnostic designed to aid Alzheimer’s disease diagnosis by analyzing urinary volatile organic compound patterns using mass spectrometry and…
Shots:
Oticon Medical has launched Ponto Instant, a non-surgical bone conduction hearing portfolio, adding Instant HearBand & Instant SoundConnector to expand wearable options for children & adults
Instant HearBand is a lightweight behind-the-head wearable alternative to Softband 5 with customizable sizing, while Instant SoundConnector attaches sound processors to headwears, offering an additional option for lifestyle…
Shots:
Tempus AI has reported clinical launch of the ArteraAI Prostate Test (mHSPC), a CLIA-certified & CAP-accredited prognostic assay designed for pts with metastatic hormone-sensitive prostate cancer (mHSPC)
ArteraAI Prostate Test (mHSPC) is an externally developed digital pathology algorithm clinically available through the Tempus AI ecosystem, with full platform integration to support personalized treatment decisions…
Shots:
Reflow Medical has reported the DEEPER CORONARY study results evaluating the short-term safety of the coronary Spur Elute Sirolimus-Eluting Retrievable Stent System for coronary ISR at EuroPCR 2026
6mos. results showed 100% freedom from MACE & all-cause mortality in nine treated pts, while all patients demonstrated improved CCS angina class with a median improvement of…
Shots:
Sensome has reported results from its INSPECT study assessing its microsensor technology integrated into a smart stylet for bronchoscopic lung biopsy in 27 pts across Australia & France
In the study, the smart stylet was inserted into the biopsy needle to capture tissue readings immediately before biopsy, with histopathology confirming measurement accuracy & cross-validating…

