Medtronic (NYSE:MDT) has hired former Recor Medical President and CEO Lara Barghout as president of the Interventional Cardiology Therapies (ICT) operating unit. The ICT business covers minimally invasive therapies in structural heart, coronary, and hypertension management, the last of which includes renal denervation (RDN). Watch on-demand: The 2026 MDO Min-Vasive Medtech webinar series Recor Medical won […]
News Well
Powerful Medical announces FDA De Novo nod for AI ECG and other extra medtech news
Powerful Medical today announced FDA De Novo authorization for its Queen of Hearts AI ECG model. According to New York–based Powerful Medical, the AI-powered model is meant to identify ECG findings suggestive of urgent acute coronary syndrome (ACS). The goal is to get urgent notifications to clinicians of suspected cases. According to Powerful Medical, the […]
Luma Vision wins expanded FDA nod for its cardiac procedure software
Luma Vision has won FDA clearance to expand the capabilities of its Verafeye cardiac ablation procedure intelligence platform. The privately held, Dublin, Ireland–based medtech plans to launch commercially in early 2027. The news comes about six months after the company said it was expanding its clinical programs after submitting to the FDA. “By bringing imaging, […]
Meet Conor Hale, MassDevice’s new senior editor
My name is Conor Hale, and I’m happy to introduce myself as MassDevice and Medical Design & Outsourcing’s new senior editor. I’ve had the pleasure of covering medical technology and the life sciences for the past 15 years from the Washington, D.C. area, at outlets including The Cancer Letter and FDAnews. Most recently, I spent […]
Siemens Healthineers completes $44M R&D, manufacturing site expansion
Siemens Healthineers completed a $43.6 million expansion of its positron emission tomography (PET) Detector Center in Rockford, Tennessee, the company announced yesterday. The project added 40,000 ft² to the nearly 100,000 ft² manufacturing and R&D facility, and will add more than 90 new jobs over the next five years, Siemens Healthineers said. “We are making […]
Next-gen Apple Watch Ultra 4 includes new health features
Apple (NASDAQ: AAPL) unveiled the Apple Watch Ultra 4 today, featuring a host of new health, fitness and safety features. The new Health Sensing System powered by Apple’s S11 chip delivers advanced heart rate measurements, step tracking and a daily readiness score. “The new Health Sensing System and S11 chip take Apple Watch Ultra 4 […]
Johnson & Johnson wins CE mark for new reusable contact lens and other extra medtech news
Johnson & Johnson MedTech (NYSE: JNJ) announced today that it has received a CE mark for its Acuvue Oasys Max 2-Week, a new reusable contact lens. According to J&J, the contact lens features proprietary Max technologies meant to to boost comfort and visual clarity, even at day 14. The company plans to roll out the […]
Verily Health secures investment from Nvidia to advance healthcare AI platforms
Verily Health secured an investment from Nvidia to advance development and commercial deployment of its precision healthcare AI platforms, the company announced today. Verily also received an additional investment from existing investor CU Healthcare Innovation Fund. “We are pleased to welcome Nvidia as a new investor in Verily. These investments strengthen our ability to pursue […]
Petal Surgical says its first-in-human incisionless surgery is coming soon and offers a first glimpse of its system
Petal Surgical is “moving out of the lab” and toward human trials of its incisionless surgery platform in the near future, the surgical tech startup tells MassDevice. The histotripsy developer is almost finished with its controlled, in-vivo preclinical studies, saying they will yield a first-of-its kind dataset demonstrating “the extent to which [the] platform can […]
Boston Scientific recalls, discontinues angiographic catheter sales
Boston Scientific recalled and discontinued all Imager II angiographic catheters due to a manufacturing issue, according to an FDA early alert. Imager II angiographic catheters are diagnostic intravascular catheters used to capture images of the patient’s peripheral vasculature. Boston Scientific determined the catheters were “manufactured with reduced levels of stabilizing agents in the tips,” according […]
MicroPort’s covered stent system receives special review in China
MicroPort Coronary announced that its FireShield coronary covered stent system will undergo the National Medical Products Administration (NMPA) special review procedures in China. The special review procedures aim to accelerate review for innovative medical devices that meet criteria for domestic originality, technical novelty and clinical value. (The FDA Investigational Device Exemption program plays a similar […]
