Pioneering a new category of robotics in healthcare, Mendaera’s Focalist™ System, cleared for precise instrument placement during ultrasound-guided procedures for one of medicine’s most common and critical techniques.
The FARAPULSE PFA System now approved for pulmonary vein and posterior wall ablation in patients with persistent atrial fibrillation.
Medtech innovator GeniPhys received 510(k) clearance from the FDA for its platform product, Collymer Self-Assembling Scaffold (SAS).
NIH-Sponsored Study Compares BEAR Implant to ACL Reconstruction for Complete ACL Tears.
Angioplasty and stenting procedures (or percutaneous coronary interventions/PCIs) are performed more than four million times around the world every year to open up blockages in coronary arteries to allow the heart to receive proper blood flow. Most of these procedures — 80-85 percent — are only guided by traditional angiography, an x-ray of the blood vessels that requires a contrast agent to be flushed into the heart to identify where the blockages are.
AI’s reach depends on the environments in which it operates as well as how it is developed and deployed, highlighting a fundamental debate on whether we should push for regulation or opt for free-market-driven deregulation.
Holmes appears to be headed for prison after an appeals court rejected her bid to remain free while she tries to overturn her conviction in a blood-testing hoax that brought her fleeting fame and fortune.
On February 15, numerous probationary staff at FDA began receiving emails notifying them they had been fired. “Unfortunately, the Agency finds that you are not fit for continued employment because your ability, knowledge and skills do not fit the Agency’s current needs, and your performance has not been adequate to justify further employment at the Agency,” said the letters.
Public Health Impact of Medical Device Supply Chain Vulnerabilities
The FDA’s Center for Devices and Radiological Health issued a statement on medical device supply chain vulnerabilities, the public health impact they have on patient care, the FDA’s actions to prevent and mitigate potential shortages, and solutions to strengthen the domestic supply chain and address these vulnerabilities.
Acquisition to expand cardiovascular portfolio with complementary and differentiated calcium modification platform, furthering company’s strategy to address coronary and peripheral disease.
