Monteris Medical today said its launch of the NeuroBlate NB3 FullFire makes it the smallest laser probe for brain procedures on the market. The 1.6mm laser fiber probe features patented NeuroBlate System cooling technology and is available in a single adjustable length. Minnetonka, Minnesota-based Monteris won FDA 510(k) clearance to add the NB3 to its […]
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Advice for building a medtech career inside a big company from BD CTO Elizabeth McCombs
In the opening keynote for DeviceTalks Boston 2024 today, BD EVP and Chief Technology Officer Elizabeth McCombs offered advice for building a medtech career inside a big company. Reflecting on her 20-year career at Johnson & Johnson MedTech (the world’s second-largest medical device manufacturer) before joining BD, McCombs advised aspiring medtech leaders to strive to deeply […]
Medtronic plans job cuts in California
Medtronic is eliminating 44 jobs in Carslbad, California, according to a mass layoff notice filed with the state. The permanent job cuts take effect starting on or around May 19 at 2101 Faraday Ave., Medtronic told the California Employment Development Department. FDA records list that address as a facility for Nellcor Puritan Bennett Corp., a […]
ClearPoint Neuro wins FDA clearance for neuro laser therapy accessory
ClearPoint Neuro (Nasdaq:CLPT) announced today that the FDA granted 510(k) clearance for its Prism bone anchor accessory. It marks the second new product introduction in 2024 for the company, with its stereotactic guidance system garnering clearance in January. The Prism system features the only non-cooled laser applicator on the market, the company said. Its next-generation laser applicator […]
How Philips’ significant respiratory devices recall unfolded
There are 5.5 million recalled CPAPs and other devices — and reports of deaths. Here’s a Philips recall timeline. Philips in mid-2021 kicked off a recall that involved millions of CPAP and BiPAP ventilators and other respiratory devices. The devices — used for sleep apnea therapy and more — had sound abatement foam that could […]
Edwards Lifesciences beats the Street in Q1 and increases sales outlook
Edwards Lifesciences reported first-quarter results that exceeded Wall Street expectations after market close today. The maker of catheter-delivered heart implants — including transcatheter aortic valve replacement (TAVR) systems and transcatheter mitral and tricuspid therapies (TMTT) — also increased its full-year sales guidance. EW’s stock price was relatively flat in after-hours trading. Irvine, California–based Edwards Lifesciences […]
Integer stock sinks despite Q1 beat as full-year forecast disappoints
Integer stock declined by 10% today despite posting Street-beating first-quarter earnings. Investors were likely reacting to the medtech contract manufacturing giant’s full-year guidance, which was less than the analyst consensus. Plano, Texas–based Integer earned $20.5 million, or 59¢ per share, off of $414.8 million in sales for the quarter ended March 29, 2024. Compared to Q1 […]
Intuitive beats the Street in Q1, increases procedure volume forecast
Intuitive Surgical posted first-quarter results today that exceeded the consensus forecast on Wall Street while increasing its forecast for full-year procedure growth. The Sunnyvale, California-based surgical robotics leader reported profits of $545 million, or $1.51 per diluted share, for the three months ended March 31, 2024, up 53% from the first quarter of 2023. Total […]
IceCure submits final breast cancer cryoablation data to FDA
IceCure Medical (Nasdaq:ICCM) announced today that it submitted final data to the FDA requesting marketing authorization for its ProSense system. Caesarea, Israel-based IceCure designed ProSense to deliver cryoablation that treats breast cancer in a 20-40-minute outpatient procedure. It seeks FDA authorization for treating patients with early-stage T1 invasive breast cancer with cryoablation and adjuvant hormone […]
TSSC seeks funding to get fiber optic sensor tech across the finish line
The Shape Sensing Co. is seeking investors to fund the productization and FDA clearance of its fiber optic sensor technology for surgical navigation. Austin, Texas-based TSSC wants to raise $10 million in the Series B round, CEO Ryan DeBoer said in an interview with MassDevice. That should be enough for two-and-a-half years of runway, enough […]
Medtronic unveils next-gen GI Genius software, partners with ModMed on AI-powered colonoscopy
Medtronic today announced advancements for its AI-powered GI Genius system, as well as a new collaboration. The company unveiled its ColonPRO latest-generation software for the GI Genius intelligent endoscopy system. GI Genius, a computer-aided polyp detection system powered by AI, has been available in the U.S. since 2021. Medtronic designed it to redefine GI screening by […]