Alcon has officially completed its acquisition of LumiThera, expanding our Retina portfolio with the Valeda® photobiomodulation (PBM) device. We look forward to broadening access to this non-invasive and efficacious treatment to dry AMD patients*⁽¹⁻²⁾, as we continue to address unmet needs in eye care. Learn more: http://spr.ly/6040ABue6 #Alcon #Retina #AMD *Dry AMD eyes with: 3 medium drusen, or 1 large drusen, or non-central involving GA; and with BCVA between 20/32 – 20/70 (i.e., early and intermediate dry AMD, and a sub-set of late dry AMD). References: 1. U.S. Food and Drug Administration. De Novo classification request for Valeda Light Delivery System (DEN230083). Accessed June 2025: http://spr.ly/6042ABue8. 2. LumiThera, Inc. A double-masked, randomized, sham-controlled, parallel group, multi-center study to assess the safety and efficacy of photobiomodulation (PBM) in subjects with dry age-related macular degeneration (AMD) (LIGHTSITE III). Clinical Study Report CSP005.

☑️ Baxter launches next-gen Welch Allyn Connex 360 Vital Signs Monitor. The device records patient vitals in under one minute and uploads directly to EMRs. ☑️ Johnson & Johnson launches Shockwave Javelin IVL catheter in Europe. The new catheter expands treatment options for patients with peripheral artery disease. ☑️ Exero Medical completes U.S. study enrolment for xBar system. The trial supports the company’s bid for FDA clearance of its postoperative monitoring device. ☑️ Vivani sets record date for Cortigent neuromod spin-off. The move allows Vivani to focus fully on its implantable drug delivery device pipeline. ☑️ Nalu Medical, Inc. secures $50M growth funding from Trinity Capital. The capital will support scaling of its implantable neurostimulation therapies. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

🚀 Big moves in Vancouver #medtech. Kardium has received FDA approval for its Globe Pulsed Field System—a new way to treat atrial fibrillation. This milestone follows a $340M CAD raise earlier this year and puts Kardium at the forefront of a global shift in cardiac care. Another example of Vancouver innovation making a worldwide impact. https://lnkd.in/gbRRDMBw

Peripheral Vascular Devices Market to Reach USD 15,721.29 Million by 2031 The global Peripheral Vascular Devices Market was valued at USD 11,247.6 Million in 2024. According to MarketsGlob, it is expected to reach USD 15,721.29 Million by 2031, growing at a CAGR of 4.9% from 2025 to 2031. Medtronic Inc. | Angiomed GmbH | Abbott Laboratories Vascular Enterprises Limited | Terumo Corporation | ENDOLOGIX Inc. | William Cook Europe ApS | Bolton Medical Inc. | Jotec GmbH | ClearStream Technologies Ltd. | Aesculap AG | Boston Scientific Corporation | Curative Medical Devices GmbH | Lepu | Microport | Bioteq | Others https://lnkd.in/d44TvCG7 ⚡ Market Drivers ✔ Rising prevalence of peripheral vascular diseases globally ✔ Increasing adoption of minimally invasive vascular procedures ✔ Advancements in stent, catheter, and graft technologies ✔ Growing demand for treatments addressing vessel damage and blockages #PeripheralVascularDevices #MedicalDevices #Stents #BalloonCatheter #AorticStentGraft #EmbolicProtection #HealthcareInnovation #MarketGrowth

Elutia has sold its drug-eluting bioenvelope technology (such as the EluPro bioenvelope shown below) to Boston Scientific for $88 million. Analysts describe the acquisition as a strong fit for Boston Scientific, since the bioenvelope tech could be used with many of the implantable devices in its portfolio. Senior Editor Sean Whooley has more details on Drug Delivery Business News and MassDevice. (DDBN link in the comments.) #medtech #meddevice #mergersandacquisitions #cardiology

The submission marks an important milestone for Conavi as we advance toward bringing our next-generation IVUS/OCT imaging solution to the U.S. market,” said Tom Looby, Chief Executive Officer of Conavi Medical. “With our pilot system already cleared by the FDA, we feel that this submission leverages a strong regulatory foundation and may provide for an efficient review process. We believe the next-generation Novasight Hybrid™ system is well positioned to capitalize on the growing adoption of intravascular imaging, a category that has been shown to improve procedural outcomes during coronary interventions.

Bayer's (OTCMKTS: $BAYRY), Gadoquatrane is now under FDA review—designed for MRI imaging at 60% lower gadolinium dose while maintaining diagnostic quality. If approved, it could redefine contrast safety. https://lnkd.in/d67s3qQy

Retina biosimilar approval news from Market Scope: South Korea’s Alteogen announced Sept. 17 that the European Commission had granted marketing authorization for #Eyluxvi (formerly ALT-L9), its biosimilar to #Eylea (#aflibercept 2 mg). #retina #biosimilar #Europe #Korea https://lnkd.in/g2JBqdpj

The recent FDA approval of Abbott’s Tendyne and CE approval of Edwards’ SAPIEN M3 confirmed that transcatheter mitral valve replacement (TMVR) is certainly a #MedTechMarketToWatch. The long-established success and durability of surgical mitral valve intervention has made the adoption of transcatheter alternatives more cautious and gradual. Despite Tendyne’s 2020 EU approval, TMVR adoption has been slow, but emerging technologies aim to overcome current limitations and expand its reach. A crowded field of innovators is racing to break into the TMVR space, each vying for a foothold in a complex and competitive market. HighLife, Cardiovalve (Venus Medtech International), 4C Medical Technologies, Inc., ReValve Solutions, Affluent Medical, InnovHeart, and Tioga Cardiovascular   Will technological advances from TMVR first movers finally overcome barriers for broader adoption? How will adoption and clinical practice differ between US and Europe?   Speaking of Europe - Susan Posner and Tracy Walters are headed to London for LSI Europe, September 7-10. Reach out to schedule a meeting if you will be there.