Medtronic Gains CE Mark for Stealth AXiS surgical system
Following recent FDA clearances, Medtronic is accelerating access to integrated planning, navigation, and robotics platform across Europe.
Medtronic Continues Cardiovascular Care Growth with Completion of CathWorks Acquisition
CathWorks FFRangio System employs drug-free, wire-free technology for comprehensive physiological assessment.
CMS, FDA Announce RAPID Coverage Pathway to Accelerate Device Reimbursement
New pathway cuts red tape and brings predictability to Medicare coverage for Breakthrough Devices.
Styker Adds IVL Technology to Peripheral Vascular Portfolio with Amplitude Acquisition
Stryker signs definitive agreement to acquire Amplitude Vascular Systems to add next-generation IVL technology to peripheral vascular portfolio
FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results
Companies and researchers often fail to disclose negative trial results, resulting in significant gaps in the public record and a publication bias that obscures the true landscape of drug development outcomes—overrepresenting successes and underrepresenting failures. This gap can also create a distorted perception of the safety and efficacy of medical products.
BD Announced Application of CE Mark for the Liverty TIPS Stent Graft
Designed to expand treatment options for patients with cirrhosis and complications of portal hypertension, this next‑generation, adjustable‑diameter device represents the latest advancement by BD in interventional therapies addressing complex liver disease, according to the company.
Blackstone and TPG Complete Acquisition of Hologic; Names New CEO
Hologic announced the appointment of José (Joe) E. Almeida as Chief Executive Officer, effective immediately upon closing of the previously announced company acquisition.
Endospan Receives FDA Approval for the NEXUS Aortic Arch Stent Graft System
The FDA has approved the NEXUS Aortic Arch Stent Graft enabling commercial launch of the NEXUS System in the US.
InVera Medical Receives FDA Clearance for Non-Thermal Chronic Venous Disease Device
The InVera Infusion Device is approved for use in the US and EU within its indications.
Allevion Medical Receives 510K Clearance for Vantage Spinal Decompression System
Allevion Medical Receives FDA Clearance for Vantage™, Introducing a Fully Disposable Approach to Minimally Invasive Spinal Decompression.