Tempus AI’s PRISM2 foundation model matched or exceeded specialised pathology products across several retrospective cancer-detection tests while also supporting biomarker and survival predictions. The results strengthen the case for general-purpose pathology artificial intelligence, but PRISM2 is not yet an FDA-authorised diagnostic device.
Medtronic has secured an expanded European CE Mark indication for its Affera Mapping and Ablation System with the Sphere-9 catheter, allowing the platform to treat ventricular arrhythmias including ventricular tachycardia and premature ventricular complexes. The August 6, 2026 regulatory expansion moves Sphere-9 beyond the atrial arrhythmias for which the system was initially commercialized. Medtronic describes
Johnson & Johnson has received FDA De Novo authorization for the OTTAVA robotic surgical system across multiple upper-abdominal procedures. Its table-integrated design could bring robotic surgery into smaller operating rooms, but clinical evidence, surgeon training and hospital economics will determine whether it can challenge Intuitive Surgical.
KKR has agreed to acquire Integer Holdings in a $5.7 billion transaction, taking one of the world’s largest medical-device development and manufacturing partners private. The deal gives KKR exposure to cardiovascular, neuromodulation and cardiac-rhythm technologies, but Integer’s slowing sales and elevated debt show why operational execution will matter after the takeover.
GRAIL, Inc. will face a potentially defining regulatory examination on September 23, 2026, when outside advisers to the United States Food and Drug Administration review the premarket approval application for its Galleri multi-cancer early detection blood test. The FDA’s Molecular and Clinical Genetics Panel is scheduled to discuss and vote on whether the available evidence
ForSight Robotics expands JASPER cataract surgery experience to 26 patients, testing whether robotic eye surgery can fit routine clinical workflow.
Kardium wins Health Canada approval for the Globe Pulsed Field System, extending its integrated atrial fibrillation platform beyond the U.S.
Australian medical robotics company Vexev has raised $6 million to support FDA regulatory work, manufacturing scale-up and U.S. commercialization of VxWave after a multicenter study showed that dialysis-clinic staff could perform semi-autonomous vascular scans with the investigational system.
Dash Bio’s $30 million Series A backs automated bioanalysis expansion, but validation, scale and sponsor adoption will determine its impact.
GE HealthCare launches Invenia ABUS Prime and ABUS StreamVue, targeting scalable dense breast screening and enterprise-wide review.