The surgical robotics space saw a major shakeup last year. “Robotics is hard. Robotics in healthcare is hard.” Hani Abouhalka, Johnson & Johnson’s company group chair for Robotics & Digital, said those words at our DeviceTalks West event in California in October. It pretty much sums up the situation for medtech companies large and small […]
News Well
CMR Surgical CEO expects another year of growth
Nearly a year after year after he took over as CEO at CMR Surgical, Supratim Bose says the surgical robotics company is set for more growth. Over the past year, the Cambridge, U.K.–based maker of the Versius surgical robotic system has moved forward on several vital initiatives to set itself up for success: The development […]
Microbot Medical expands U.S. operations to prep for first in-human clinical study
Microbot Medical, the developer of the Liberty endovascular robotic surgical system, is building on the momentum from the positive results of its good laboratory practices (GLP) pre-clinical study. The company is adding a clinical research associate to support its pending investigational device exemption, or IDE, submission to commence its first-in-human clinical trial. The clinical research […]
FastWave Medical kicks off first-in-human study of its IVL tech
FastWave Medical announced the successful completion of enrollment for its first-in-human study of its peripheral intravascular lithotripsy (IVL) system to treat calcified cardiovascular disease. Dr. Miguel Montero-Baker of Houston Methodist Hospital and the Hope Vascular & Podiatry Clinic and Dr. Venkatesh Ramaiah of HonorHealth Vascular Group and the Pulse Cardiovascular Institute successfully conducted the procedures […]
Apple reportedly pulling pulse oximetry from watches if Masimo case appeal fails
Federal customs officials have reportedly approved Apple’s workaround to continue importing Series 9 and Ultra 2 watches if it fails in its appeal of an import ban in its patent dispute with Masimo. The consumer tech giant has told U.S. Customs and Border Protection that redesigned watches “definitively do not contain pulse oximetry functionality,” according […]
FDA clears stereotactic guidance system from ClearPoint Neuro
ClearPoint Neuro (Nasdaq:CLPT) announced today that it received FDA 510(k) clearance for its SmartFrame OR stereotactic system. Solana Beach, California–based ClearPoint Neuro developed its SmartFrame OR system with two main components. It features the SmartFrame OR technology with the ClearPointer optical navigation wand. SmartFrame OR offers stereotactic guidance for placing and operating instruments or devices […]
3M picks former NuVasive CEO as president of Medical Solutions
3M announced that it named Chris Barry EVP and group president of its Medical Solutions Division. Medical Solutions exists within the 3M Health Care business group. 3M expects to spin off its Health Care business in the first half of this year, after which point it will operate under the name “Solventum.” Barry, the former […]
Integer acquires Pulse Technologies for $140M
Medtech contract manufacturing giant Integer Holdings announced that it has bought Quakertown, Pennsylvania–based Pulse Technologies. The size of the deal was roughly $140 million. It closed on Jan. 5 and utilized borrowings under Integer’s existing revolving credit facility. Pulse Technologies is a privately-held medtech supplier focusing on complex micromachining of medical device components for high-growth […]
PTAB to review Apple’s ECG patents amid legal battle with AliveCor
The U.S. Patent Trial and Appeal Board (PTAB) will review two Apple-owned electrocardiogram technology patents in an infringement suit as AliveCor looks to overcome a setback with the board in December 2023. A panel of administrative patent judges granted AliveCor’s bid for a review, citing a “reasonable likelihood” that AliveCor would successfully show the unpatentability […]
ResMed CPAP masks recall is Class I
The FDA announced that ResMed’s voluntary recall of millions of CPAP mask magnets is now Class I, the agency’s most serious level. Last month, ResMed warned CPAP users about potential magnetic interference when magnets go near certain implants and medical devices in the body. People using CPAP masks with magnets only need to return […]
FDA clears painful diabetic neuropathy neurostim therapy from Neuralace
Neuralace Medical announced today that it received FDA clearance for its chronic painful diabetic neuropathy (PDN) treatment. San Diego–based Neuralace says this marks the first-ever FDA clearance of a non-invasive, magnetic peripheral nerve stimulation (mPNS) treatment for PDN. The company says its Axon Therapy could offer “new hope” to millions with the condition. Axon Therapy […]