The shift to more connected health isn’t showing signs of slowing down, and medtech continues to play a significant role. Especially in the United States, there is still a need for reforms in how healthcare is delivered and paid for to enable more remote delivery of healthcare monitoring and therapies. Nevertheless, the medtech behind connected […]
About Chris Newmarker
Philips has another Class I level ventilator recall
Philips continues to have serious respiratory device recalls, more than three years into a major safety crisis for its Respironics business. Yesterday, the FDA designated a recall of Trilogy Evo, Trilogy EV300, Trilogy Evo O2, Trilogy Evo Universal ventilators as Class I, it’s most serious level. Philips says the action involves roughly 90,000 units worldwide, […]
SetPoint Medical gets FDA IDE to study neurostimulation for MS
SetPoint Medical today announced FDA Investigational Device Exemption approval to study its proprietary neuroimmune modulation platform for people with relapsing-remitting multiple sclerosis. Valencia, California–based SetPoint plans to initiate a multicenter, randomized, double-blind, sham-controlled pilot study in 2025. The plan is to enroll 60 people across the United States. “We look forward to initiating this pilot […]
Medtronic launches VitalFlow ECMO system
Medtronic today announced the launch of the VitalFlow extracorporeal membrane oxygenation (ECMO) system. The world’s largest medtech company acquired the technology by purchasing MC3 Cardiopulmonary in March. Medtronic described the deal as the culmination of MC3’s eight-year partnership and distribution agreement with the Medtronic Cardiac Surgery business. The partnership resulted in the introduction of seven […]
Boston Scientific wins Farapulse PFA approval in Japan
Boston Scientific continues to expand the reach of its Farapulse pulsed field ablation system for treating atrial fibrillation. The Marlborough, Massachusett–based company announced today that Japan’s Pharmaceuticals and Medical Device Agency has approved Farapulse, which is indicated for the isolation of pulmonary veins in the treatment of paroxysmal atrial fibrillation. Medtronic announced Japanese approval of […]
Masimo CEO Joe Kiani faces shareholder vote today
Masimo shareholders today will decide on a bitter proxy fight between the company’s founder and CEO Joe Kiani and Politan Capital Management. In July, the digital health pioneer delayed its annual shareholders meeting to Sept. 19, so it had time to sue Politan in federal court in California over accusations of material misstatements in communications […]
Smith+Nephew announces first Catalystem hip system procedures
Smith+Nephew recently announced the first completed cases with its Catalystem primary hip system. The British orthopedic and sports medicine device giant designed Catalystem to meet the evolving demands of primary hip surgery, including the increased adoption of anterior approach procedures. The system’s features include a triple-taper stem with uniform proximal loading. According to S+N, the […]
GE HealthCare picks up FDA nod for new brain imaging tool for Alzheimer’s
GE HealthCare announced today that the FDA has cleared its new imaging tool to assess people with potential Alzheimer’s disease. The FDA 510(k) clearance covers performing Centiloid scaling for positron emission tomography (PET)-based amyloid imaging analysis and quantification. Available with MIMneuro – a vendor-neutral solution – the new Centiloid scale tool can help clinicians more […]
Zimmer Biomet is phasing out hip system amid recall
Zimmer Biomet is voluntarily phasing out its CPT hip system amid a voluntary recall. The FDA today issued an alert to people with the hip system, their caregivers, and healthcare providers that warns of increased risk of thigh bone fracture after surgery (postoperative periprosthetic femoral fracture) with the use of ZB’s CPT hip system femoral […]
Zeto inks partnership with Firefly Neuroscience
Zeto has formed a partnership with Firefly Neuroscience that boosts the distribution of Zeto’s FDA-cleared EEG headset devices. The strategic partnership, announced yesterday, makes Buffalo, New York–based Firefly a non-exclusive distributor of Santa Clara, California–based Zeto’s headset. The collaboration also includes the integration of Firefly’s proprietary Brain Network Analytics (BNA) technology with the EEG platforms, […]
Medical Alley partners with Canadian VC firm
Medical Alley — the trade group for medtech’s major hub in Minnesota — has formed a strategic alliance with Canadian VC firm iGan Partners. The partnership has iGan working with the Minnesota group’s startup venture platform Medical Alley Starts. The group brings an extensive network in Minnesota and beyond to the partnership, and iGan has […]
