The LARS ACJ clearance gives the French orthopaedic company a first US regulatory milestone for its synthetic ligament platform....
The integrated catheter platform allows electrophysiologists to deliver radiofrequency and pulsed field energy through a single device....
The FDA-cleared bone conduction sound processor adds rechargeable use, improved sound processing and wider streaming options for hearing implant users....
Leqembi Iqlik is a first-of-its-kind anti-amyloid treatment worldwide, offering at-home dosing for initiation and maintenance...
The device also connects to the RunStar app via Bluetooth, allowing readings and measurement data to automatically sync to the platform ...
The certification covers AI governance across the company's eQMS and EDC products, giving medical device companies independently verified evidence for audits and vendor qualification...
The 2026 programme recognises AI startups across biopharma, genomics, digital health, medical devices and medical imaging with $1.4 million in compute and inference credits....
Draft amendments to the Medical Devices Rules, 2017 would compress approval timelines across risk classes while preserving quality, safety and performance benchmarks and improving ease of doing business....
The power-injectable implantable port system is designed to support long-term vascular access in adult and paediatric patients....
New 18,000-square-foot facility strengthens operational capabilities while enabling expansion of Wayne, NJ-based service centre and technician workforce...
