Beta Bionics announced today that it began the U.S. launch of its iLet bionic pancreas with the Dexcom G7 continuous glucose monitor (CGM). The launch marks the second G7-compatible automated insulin delivery system to hit the market in as many days. Yesterday, Tandem Diabetes Care became the first to launch an artificial pancreas using Dexcom’s […]
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Edwards plans to spin off critical care business next year
Edwards Lifesciences announced today that it intends to spin off its critical care business by the end of 2024. The company shared a number of key plans going forward as it outlined its plans for future growth. Among its plans, Edwards expects to spin off the critical care unit and its full range of smart […]
FDA clears fingertip blood collection device from BD
BD announced today that the FDA granted 510(k) clearance to its MiniDraw novel blood collection device. Franklin Lakes, New Jersey-based BD’s device obtains blood samples from a fingerstick, producing lab-quality results for commonly ordered blood tests. BD designed MiniDraw as a less invasive device compared to traditional venous blood draw. A trained healthcare worker can […]
Ambu has a reimbursement win for its single-use bronchoscope
Ambu announced today that CMS has approved a transitional pass-through (TPT) payment for its aScope 5 Broncho HD. The TPT payment, effective Jan. 1, 2024, will last for 24–36 months, allowing incremental reimbursement for outpatient procedures using the device. The aScope 5 Broncho HD series is Ambu’s latest generation of single-use bronchoscope. Cleared by the […]
Medtronic wins CE mark for rechargeable deep brain stimulation tech
Medtronic announced that it received CE mark approval for its Percept RC neurostimulation device. The medtech giant labeled the deep brain stimulation (DBS) device as the smallest and thinnest device on the market. Also rechargeable, the system features BrainSense sensing technology. Medtronic says its launch marks the first release of a rechargeable DBS system with […]
Tandem Diabetes Care launches first automated insulin pump integrated with Dexcom G7 CGM
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it launched its updated t:slim X2 insulin pump software with the Dexcom G7. Integration makes Tandem the first to offer automated insulin delivery with the latest-generation Dexcom continuous glucose monitor (CGM). The FDA cleared the next-generation Dexcom G7 in December 2022. By February of this year, the company began […]
Levita Magnetics takes its MARS robotic surgery platform international
Levita Magnetics today announced the international launch of its MARS (magnetic-assisted robotic surgery) system with its placement at Hospital Luis Tisne in Santiago, Chile. Dr. Julio Jimenez used the system to perform same-day-discharge cholecystectomies (gallbladder removal) and bariatric surgeries. Jiminez previously helped Levita Magnetics with its clinical trials, said Levita Magnetics founder, CEO and President […]
Exactech wins clearance for new ankle surgery navigation system
Exactech announced today that its BlueOrtho subsidiary has received FDA 510(k) clearance for ExactechGPS Ankle. The Gainesville, Florida–based company described the system as the first of its kind for total ankle arthroplasty. It connects the preoperative plan with real-time intraoperative instrument guidance, confirming that resections meet the surgical plan. Designed to improve surgical precision, the […]
Johnson & Johnson’s Ethicon settles more Physiomesh suits
Johnson & Johnson has settled more than 200 cases remaining in a multi-district litigation over hernia mesh made by its Ethicon subsidiary. U.S. District Court Judge Richard Story in Northern Georgia on Dec. 1 agreed to dismiss the cases with prejudice at the request of lawyers for both sides. The lawyers had informed him that […]
EndoQuest raises $42M for endoluminal robotic tech
EndoQuest Robotics announced that it closed a C-1 preferred financing round worth $42 million in proceeds. The Houston-based endoluminal surgical robotic technology developer earmarked the funding to aid its development efforts. It expects the funds to fuel the advancement of its flexible endoluminal robot for minimally invasive procedures. EndoQuest designed its platform to address unmet […]
Johnson & Johnson MedTech says new products will fuel growth
Johnson & Johnson considers itself “uniquely positioned to lead the next wave of healthcare innovation.” Ahead of a meeting with the investment community today, the company outlined its views on where it stands in the medtech and pharmaceutical markets. New Brunswick, New Jersey-based Johnson & Johnson set long-term financial targets, including at least 3% sales […]